Protocol - Risk Factor Assessment in Blood Donors

Protocol - TTIMS.pdf

Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation

Protocol - Risk Factor Assessment in Blood Donors

OMB: 0910-0841

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Transfusion-Transmissible	Infections	Monitoring	System	(TTIMS)	
Laboratory	and	Risk	Factor	Database	Coordinating	Center	(LRCC)	

Risk	Factor	Assessment	in	Blood	Donors	

Protocol	1	

11	July	2017	

Protocol	Synopsis	
	
The	Transfusion-Transmissible	Infections	Monitoring	System	(TTIMS)	Laboratory	and	Risk	Factor	
Database	Coordinating	Center	(LRCC)	project	has	two	primary	responsibilities	in	TTIMS.	The	first	
responsibility	is	to	lead	the	collection,	evaluation	and	analysis	of	risk	factors	in	blood	donors	who	have	
HIV	(NAT	yield	and	seropositive),	HCV	(NAT	yield)	and	HBV	(NAT	yield)	positive	blood	donors	(Protocol	
1).	The	second	responsibility	is	to	establish	a	biospecimen	repository,	conduct	laboratory	analyses	of	HIV	
seroprevalent	infections	to	be	able	to	classify	them	as	newly	acquired	or	long	standing,	and	to	
determine	genotypes	and,	where	applicable,	drug	resistance	profiles	for	HIV	(NAT	yield	and	
seropositive),	HCV	(NAT	yield)	and	HBV	(NAT	yield)	infections	(these	activities	are	described	in	a	
separate	Protocol	2	document).		
	
The	overall	objectives	of	Protocol	1	procedures	are	to:	a.)	Coordinate	the	collection	of	risk	factor	data	by	
the	participating	blood	centers	from	enrolled	donors	meeting	consensus	definitions,	b.)	Combine	risk	
factor	data	and	disease	marker	surveillance	information	across	different	blood	collection	organizations;	
c.)	Evaluate	and	monitor	risk	factor	data	of	donors	and	their	donations	confirmed	to	be	positive	for	
transfusion-transmissible	viral	infections;	and	d.)	Compare/analyze	risk	factor	data	to	those	obtained	in	
the	REDS-II	TTI	Marker	Prevalence	and	Donor	Risk	Factor	Study.	The	specific	aim	of	this	part	of	LRCC	
activities	is	to	catalog	contemporary	risk	factors	for	the	purpose	of	understanding	how	blood	donors	
became	infected	with	a	transfusion-transmissible	virus.	While	the	likely	risk	factors	for	acquisition	of	
HIV,	HCV,	and	HBV	are	known,	the	relative	frequency	of	such	risk	factors	in	US	blood	donors	is	not	well	
known,	and	could	change	over	time	as	blood	donor	eligibility	criteria	are	modified.	Blood	donors	with	
infections	that	meet	the	study	consensus	case	definitions	as	well	as	false-positive	control	donors	at	the	
American	Red	Cross,	Blood	Systems,	Inc.,	New	York	Blood	Center,	and	OneBlood	will	be	asked	to	
complete	a	risk	factor	questionnaire	following	notification	of	their	test	results	via	routine	blood	center	
procedures.	Each	organization	will	interview	its	own	blood	donors.	Consent	and	interview	responses	will	
be	captured	electronically.	A	participation	incentive	linked	to	completion	of	the	risk	factor	interview	will	
be	provided	to	each	participant.	Data	analysts	at	the	LRCC	will	generate	monthly,	quarterly,	and	annual	
reports	of	risk	factors.	Analyses	will	be	stratified	by	infection,	donor	demographics,	and	US	Department	
of	Health	and	Human	Services	Public	Health	Service	region	so	that	the	relative	proportion	of	specific	risk	
behaviors	such	as	men	having	sex	with	men	(MSM),	multiple	heterosexual	partners	(MHP),	and	injection	
drug	use	(IDU)	can	be	monitored	for	proportional	changes	over	time.	In	addition,	research	publications	
will	be	developed	to	more	completely	describe	the	risk	factor	findings	reported	by	blood	donors	who	
have	HIV	(NAT	yield	and	seropositive),	HCV	(NAT	yield)	or	HBV	(NAT	yield)	infections	in	combination	with	
other	results	from	the	TTIMS	program.		
	
	

2	

Table	of	Contents	

Protocol	Synopsis	...................................................................................................................	2	
Background	and	Significance	..................................................................................................	4	
Objectives	..............................................................................................................................	8	
Specific	Aims	of	Risk	Factor	Assessment	.................................................................................	8	
Study	Procedures	and	Tasks	..................................................................................................	10	
Study	Population	...........................................................................................................................	10	

Risk	Factor	Survey	Administration	........................................................................................	17	
Analyses	and	Reporting	........................................................................................................	18	
Triggered	Follow-up	Investigations	.......................................................................................	19	
Statistical	Considerations	......................................................................................................	19	
Risk	Factor	Questionnaire	Content	.......................................................................................	22	
Prospective	and	Retrospective	Interviews	............................................................................	22	
Human	Subjects	Considerations	............................................................................................	22	
Timeline	...............................................................................................................................	24	
References	............................................................................................................................	25	
Appendices	...........................................................................................................................	27	
Appendix	1	–	TTIMS	DDCC	and	LRCC	Information	Flow	Diagram	.....................................................	27	
Appendix	2	–	Risk	Factor	Frequencies	Reported	by	Donors	During	the	REDS-II	Study	.....................	28	
Appendix	3	–	TTIMS	Study	Information	Mailer	for	Cases	(English	version)	......................................	31	
Appendix	4	–	TTIMS	Study	Information	Mailer	for	Cases	(Spanish	version)	....................................	33	
Appendix	5	–	TTIMS	Study	Information	Mailer	for	Controls	(English	version)	.................................	34	
Appendix	6	–	TTIMS	Study	Information	Mailer	for	Controls	(Spanish	version)	................................	36	
Appendix	7	–	Study	Management	System	Core	Content	.................................................................	37	
Appendix	8	–	TTIMS	Risk	Factor	Questionnaire	(English	version)	....................................................	39	
Appendix	9	–	TTIMS	Risk	Factor	Questionnaire	(Spanish	version)	...................................................	61	

	
	

	

3	

Laboratory	and	Risk	Factor	Coordinating	Center	
Protocol	1	–	Risk	Factor	Assessment	and	Analysis	
Background	and	Significance	
Approximately	4.5	million	US	patients	receive	red	cell	transfusions	each	year	and	millions	of	other	
patients	receive	platelets	and/or	plasma.1	Preventing	the	transmission	of	infections	to	persons	requiring	
transfusion	is	of	paramount	importance.	Information	on	current	risk	factors	for	viral	infections	in	blood	
donors	was	largely	unavailable	in	the	US	until	the	REDS-II	Marker	Rates	and	Donor	Risk	Factor	Study	
(DRFS)	was	completed.2	Blood	donors	from	four	large	blood	centers	were	included	in	a	case-control	
study	of	donors	with	confirmed	infections	(cases)	and	a	comparison	population	of	donors	with	repeat	
reactive	unconfirmed	infections	(false	positive	donors,	classified	as	controls).		
American	Red	Cross	(ARC),	Blood	Systems,	Inc.	(BSI),	New	York	Blood	Center	(NYBC),	and	OneBlood	
participated	in	the	case-control	study	from	2010	to	2013.	Donors	with	serologic	and	nucleic	acid	testing	
(NAT)	or	NAT-only	confirmed	human	immunodeficiency	virus	(HIV),	hepatitis B	virus	(HBV),	hepatitis C	
virus	(HCV)	infections	(cases)	and	donors	with	false-positive	results	(controls)	were	interviewed	for	
putative	behavioral	and	demographic	risks.		
	
Frequencies	of	putative	risk	factors	from	that	study	are	provided	separately	for	males	and	females	with	
regard	to	sexual	exposures	and	grouped	together	for	other	exposures	(Appendix	2	Table	1).	Male	HIV	
and	HBV	cases	had	similar	numbers	of	female	sexual	partners	as	did	controls	(median	4	and	6,	
respectively),	but	male	HCV	and	HTLV	cases	reported	higher	numbers	of	female	partners	(median	15	
and	10,	respectively).	Over	60%	of	male	HIV	cases	reported	MSM	behavior,	including	over	50%	in	the	
last	12	months;	this	was	not	common	for	HBV,	HCV	or	controls.	For	females,	higher	numbers	of	sexual	
partners	were	reported	for	HIV	(median	10)	and	HCV	(median	9)	cases,	but	not	for	HBV	or	controls.	
Sexually	transmitted	diseases	were	frequently	reported	by	female	HIV,	and	HCV-infected	donors	(3536%);	HCV-infected	female	donors	also	frequently	reported	sex	with	an	injection	drug	user	(IDU).	When	
both	sexes	were	combined,	HCV-infected	donors	reported	the	highest	frequencies	of	injecting	drugs,	
steroids	or	vitamins,	or	using	non-injection	drugs,	or	receiving	a	blood	transfusion	in	the	period	of	19582011	with	50%	of	transfusions	occurring	≤1990.	Reporting	having	ever	spent	three	or	more	days	in	jail,	a	
detention	center,	shelter	or	group	home	was	associated	with	all	four	viral	infections,	but	was	highest	
among	HCV	cases.	In	contrast,	HBV-infected	donors	were	more	likely	to	report	having	lived	abroad	or	
immigrated	to	the	US,	or	having	an	HBV	or	HCV	infected	family	member.	
	
Before	the	DRFS,	other	studies	of	risk	factor	profiles	among	HIV-infected	donors	were	funded	by	the	
CDC	for	approximately	10	years	after	implementation	of	serologic	screening	in	the	mid-1980s,	and	
studies	of	HCV-seropositive	donors	were	conducted	in	the	early	1990s.3	A	study	of	risk	factors	for	HCV	
infection	in	nucleic	acid	positive	(NAT)	anti-HCV	negative	donors	from	the	early	2000s	was	also	
reported.4		
	
ARC	has	conducted	infection	trend	analyses.5,6	The	findings	show	continued	HIV	risk	with	the	prevalence	
of	HIV	in	first-time	donors	hovering	around	10	per	100,000	donations	in	each	year	of	the	10-year	period	
studied	and	the	incidence	in	repeat	donors	increasing	from	1.49	per	100,000	person-years	in	1999-2000	
to	2.16	per	100,000	persons-years	in	2007-2008.7	While	the	prevalence	of	HCV	in	first-time	donors	
decreased	over	this	time	interval	from	345	to	163	per	100,000	donations,	the	incidence	in	repeat	donors	
did	not	decrease	and	evidence	of	incident	infection	in	first-time	donors	increased.	Moreover	specific	
4	

age,	gender	and	minority	race/ethnicity	groups	were	over-represented.	Significantly	increased	incidence	
of	both	HIV	and	HCV	were	observed	in	2007-2008	compared	to	2005-2006.	Similar	analyses	for	HBV	
have	shown	an	incidence	in	all	donors	of	3.4	per	100,000	person-years	which	is	lower	than	earlier	
estimates,	but	remains	higher	than	for	HIV	and	HCV.8	
	
Brief	reviews	of	older	studies	of	HIV,	HCV,	HBV	risk	factors	are	provided	to	establish	a	historical	context	
for	the	epidemiology	of	each	of	these	infections	in	blood	donors.		
	
HIV	
Among	38,000	persons	in	33	states	with	confidential	name-based	HIV	infection	reporting	in	2004,	malemale	sex	was	the	most	frequently	reported	transmission	category,	followed	by	heterosexual	contact	and	
IDU.9	The	1999-2002	National	Health	and	Nutrition	Examination	Survey	(NHANES)	results	show	that	nonHispanic	black	participants	(N=1283)	who	reported	ever	using	cocaine/street	drugs,	in	addition	to	those	
who	tested	positive	for	the	presence	of	HSV-2	antibody,	had	a	higher	prevalence	of	HIV	infection.10	In	
blood	donors,	risk	factors	reported	by	HIV	seropositive	donors	from	over	20	years	ago	were	different	for	
males	and	females.		In	males,	male-male	sex	was	most	common	followed	by	IDU,	then	sex	with	an	IDU,	
but	27%	did	not	disclose	or	could	not	identify	a	risk,	whereas	in	females,	sex	with	males	at	risk	for	HIV	
was	most	common	(81%	of	whom	were	IDU)	followed	by	IDU,	but	41%	did	not	disclose	or	could	not	
identify	a	risk.11,12	
	
HCV	
Hepatitis	C	is	the	most	common	blood-borne	infection	in	the	United	States,	and	risk	factors	are	
associated	with	percutaneous	or	mucosal	exposures	to	blood	or	blood-derived	body	fluids.	A	national	
population-based	survey	NHANES	III,	1988-1994)	surveyed	approximately	15,000	participants	and	found	
that	a	history	of	injection	drug	use	was	the	strongest	risk	factor	for	HCV	infection.13	Other	significant	risk	
factors	included	20	or	more	lifetime	sexual	partners,	and	blood	transfusion	before	1992.	Among	blood	
donors,	a	matched	case-control	study	of	2,300	participants	showed	that	injection	drug	use	was	highly	
associated	with	HCV	seropositivity	and	was	the	most	common	risk	factor	reported	by	US	blood	donors	
(about	50%).14	Data	from	the	Centers	for	Disease	Control	and	Prevention	from	1995-2000	demonstrate	
that	most	newly	acquired	infections	are	associated	with	injection	drug	use,	followed	by	exposure	to	an	
infected	sex	partner	or	to	multiple	sex	partners,	health	care	work	with	frequent	exposure	to	blood,	and	
rarely,	nosocomial,	iatrogenic	and	perinatal	exposures.15	HCV	NAT	positive,	anti-HCV	negative	blood	
donors	had	the	following	risk	factors,	recent	injection	drug	use	(IDU),	followed	by	occupational	
exposure,	sexual	contact	with	an	HCV-infected	partner	(who	was	an	IDU),	and	perinatal	exposure.4	
	
HBV	
The	1988-1994	NHANES	data	(N=40,000)	demonstrate	that	black	race,	increasing	number	of	sexual	
partners,	and	non-US	place	of	birth	were	highly	associated	with	HBV	infection.16		Centers	for	Disease	
Control	and	Prevention	surveillance	data	from	1990-2004	show	that	the	proportion	of	acute	HBV	cases	
reporting	multiple	sexual	partners	and	male-male	sex	doubled	over	this	time	period,	indicating	that	
these	behaviors	are	associated	with	increased	risk	of	HBV	transmission.17	
	
The	greatest	improvements	in	infectious	disease	blood	safety	come	from	preventing	the	donation	of	
blood	from	infected	donors.	To	increase	the	probability	of	preventing	such	donations,	blood	collection	
organizations	need	to	be	able	to	aggregate	data	to	understand	larger	patterns	across	organizations.	
Standardized	data	coding,	research	database	processes,	and	data	collection	procedures	across	
organizations	will	benefit	transfusion	safety.	Identifying	and	reporting	risk	factors	for	viral	infections	in	
confirmed-positive	viremic	and	seropositive	donors	is	not	mandated	by	the	US	FDA	or	required	by	blood	
5	

organizations	or	standard-setting	bodies.	Risk	factor	assessment	by	blood	organizations	is	currently	
done	as	part	of	individual	donor	notification	and	counseling	by	blood	centers,	but	not	in	a	systematic	
way	within	or	across	organizations.	A	systematic	collection	of	risk	factor	data	will	enhance	the	
information	already	contained	in	the	centers’	databases	and	allow	the	FDA	and	other	agencies	to	
monitor	the	impact	of	changes	in	donor	eligibility	policies.		
	
In	the	REDS-II	Infection	Marker	Rates	and	DRFS,	donors	with	donations	that	tested	false	positive	
(controls)	were	interviewed	as	a	comparison	population.	These	false-positive	donors	included	donors	
who	tested	HIV,	HCV,	HBV,	or	HTLV	serology	repeat	reactive	on	one	screening	test	but	were	not	
confirmed	to	have	infection.	Controls	were	not	matched	to	cases	on	any	demographics	or	other	factors.	
The	inclusion	of	controls	allowed	for	an	analytical	assessment	of	the	statistical	association	and	odds	of	
infection	comparing	risk	behaviors	and	demographics	between	those	with	confirmed	infections	(cases)	
to	uninfected	donors.	Table	1	provides	risk	behavior	results	showing	the	odds	of	HIV	infection	between	
cases	and	controls	from	the	REDS-II	study	and	Table	2	provides	risk	behavior	results	associated	with	HCV	
infection.			
	
Table	1.	Statistical	measures	of	behavioral	risk	factors	associated	with	HIV	infection	in	blood	donors	
from	the	REDS-II	US	Risk	Factor	Study.2			
Adjusted	Odds	Ratio,*		
95%	Confidence	Interval	&	p-value	
Sex	with	someone	who	is	HIV+	
131.7	
26.7	–	650.1	
<0.001	
MSM	
62.3	
27.6	–	140.4	
<0.001	
Injection	drug	use	
3.1	
0.3	–	28.5	
0.30	
3+	nights	in	detention/jail	
2.4	
1.2	–	4.8		
<0.01	
Tattoo,	body	piercing,	or	3+	ear	piercings	
2.8	
1.6	–	4.8	
<0.001	
Multiple	sexual	partners	in	last	year	
2.3	
1.4	–	3.8	
<0.01	
*	Adjusted	for	gender,	age,	race/ethnicity,	income,	first	time/repeat	donor	status.		
	
Table	2.	Statistical	measures	of	behavioral	risk	factors	associated	with	HCV	infection	in	blood	donors	
from	the	REDS-II	US	Risk	Factor	Study.2			
Factors	Associated	with	HCV	Infection	in	Blood	
Adjusted	Odds	Ratio*,	95%	
Donors	
Confidence	Interval	&	p-value	
IDU	
42.1	
13.0	–	136.3	
<0.001	
Household	member	with	Hepatitis	
15.4	
5.9	–	40.3		
<0.001	
Sex	with	IDU	
9.7	
4.4	–	21.2	
<0.001	
3+	nights	in	detention/jail		
7.5	
4.3	–	12.9	
<0.001	
Transfusion	Ever	
5.1	
2.7	–	9.6		
<0.001	
Tattoo	or	body	piercing	
3.5	
2.0	–	5.9	
<0.001	
*Adjusted	for	gender,	age,	race/ethnicity,	education,	first-time/repeat	status,	born	in	the	US	
	
Controls	are	equally	important	as	part	of	TTIMS	for	understanding	the	behavioral	characteristics	of	the	
uninfected	donor	population.	The	controls	that	were	interviewed	for	the	REDS-II	Study	would	not	serve	
as	appropriate	comparison	controls	for	blood	donors	with	infections	during	the	TTIMS	period	(2015	–	
2019)	for	two	reasons.	First,	directly	comparing	risk	behaviors	between	false-positive	donors	from	the	
REDS-II	Study	(2011	–	2012)	with	cases	from	TTIMS	would	involve	a	time	period	difference	of	4	to	8	
years	depending	on	when	the	TTIMS	cases	are	interviewed.	Secular	and	other	changes	in	the	donor	base	
between	the	two	time	periods	could	lead	to	substantial	bias,	particularly	with	respect	to	the	
Factors	Associated	with	HIV	Infection	in	Blood	Donors	

6	

demographics	of	donors	as	the	number	of	blood	donations	and	the	approach	to	donor	recruitment	in	
the	US	have	significantly	changed	over	the	this	time	period.	Second,	because	the	blood	donation	
eligibility	rule	for	MSM	has	now	changed,	it	is	important	to	assess	if	there	have	been	changes	in	
undisclosed	risk	behaviors	in	accepted	donors	with	and	without	infection.	Further,	by	conducting	control	
interviews	in	TTIMS,	we	will	also	be	able	to	assess	if	the	rates	of	undisclosed	risk	behaviors	such	as	MSM	
are	different	between	the	REDS-II	Study	and	TTIMS	time	periods.		
	
This	project	represents	a	collaborative	study	that	will	include	a	comprehensive	interview	study	of	viral	
infection	positive	blood	donors	at	the	ARC,	BSI,	NYBC	and	OneBlood	in	order	to	identify	the	current	
predominant	risk	factors	for	virus-positive	donations	and	will	also	establish	a	donor	biovigilance	capacity	
that	currently	does	not	exist	in	the	US.	Combined	data	are	critical	for	appropriate	national	donor	
infectious	disease	monitoring	efforts.	In	addition,	with	implementation	of	changes	in	the	indefinite	
donor	deferral	for	men	who	have	sex	with	men	(MSM)	to	a	1-year	deferral	since	last	MSM	contact,18	
monitoring	the	relative	prevalence	of	risk	behaviors	in	donors	with	confirmed	infection	is	important	for	
the	assessing	changes	in	risk	following	modification	of	the	deferral.19		Data	collected	by	TTIMS	will	be	
useful	for	both	regulatory	and	educational	reasons.	For	example,	this	information	could	be	used	to	
target	educational	interventions	to	reduce	donations	from	persons	with	high	risk	behaviors.	This	is	
particularly	important	in	the	case	of	behaviors	associated	with	incident	(recently	acquired)	infections;	
these	donations	have	the	greatest	potential	transmission	risk	because	they	could	be	missed	during	
routine	testing.	The	combined	database	will	capture	infectious	disease	and	risk	factor	information	on	
nearly	60%	of	all	blood	donors	and	donations	in	the	country.	
	

7	

Objectives	
	
The	LRCC	project	has	two	primary	responsibilities	in	TTIMS.	The	first	responsibility	is	to	lead	the	
collection,	evaluation	and	analysis	of	risk	factors	data	in	blood	donors	who	have	HIV	(NAT	yield	and	
seropositive),	HCV	(NAT	yield)	and/or	HBV	(NAT	yield)	positive	donations	and	also	donors	who	test	
repeat	reactive	but	do	not	confirm	positive	based	on	supplemental/confirmatory	testing	for	the	same	
infections	will	be	interviewed.	The	unconfirmed	(false	positive)	donors	will	serve	as	a	comparison	group	
to	the	confirmed	positive	donors	(items	1	–	4	below).	The	second	responsibility	is	to	establish	a	
biospecimen	repository,	conduct	laboratory	analyses	of	HIV	seroprevalent	infections	to	be	able	to	
classify	them	as	newly	acquired	or	long	standing,	and	to	determine	genotypes	and,	where	applicable,	
drug	resistance	profiles	for	HIV	(NAT	yield	and	seropositive),	HCV	(NAT	yield)	and	HBV	(NAT	yield)	
infections	(these	activities	are	described	in	a	separate	Protocol	2	document).	
	
The	TTIMS	LRCC	project	purpose	is	to	serve	as	the	coordinating,	laboratory,	and	analytical	center	for	
analyses	relevant	to	the	evaluation	and	monitoring	of	HIV	(NAT	yield	and	seropositive),	HCV	(NAT	yield)	
and	HBV	(NAT	yield)	positive	blood	donor	risk	factor	data,	molecular	surveillance	data	and	HIV	recency	
testing	data.	Specifically,	the	primary	objectives	are	to:	
	
1. Coordinate	the	collection	of	risk	factor	data	by	the	participating	blood	centers	where	donors	with	
infections	and	donors	who	tested	false	positive	donated.	
2. Integrate	risk	factor	data	and	disease	marker	surveillance	information	across	different	blood	
collection	organizations.	
3. Evaluate	and	monitor	risk	factor	characteristics	of	donors	and	donations	confirmed-positive	for	
transfusion-transmissible	infections.	
4. Compare/analyze	risk	factor	data	to	those	obtained	in	the	REDS-II	Marker	Prevalence	and	DRFS.	
5. Provide	logistical	support	for	the	TTIMS	project	and	for	the	Committee/Subcommittee	meetings,	
conferences,	and	donation(s)	transfer/shipment.	
6. Serve	as	the	biospecimen	repository	for	the	TTIMS	project.	
7. Perform	recency	testing	on	HIV	plasma	samples	from	donors	with	seropositive	infection	to	establish	
estimates	of	time	of	HIV	acquisition.	
8. Conduct	viral	genetic	sequence	analyses	on	plasma	samples	for	HIV	(NAT	yield	and	seropositive),	
HCV	(NAT	yield)	and	HBV	(NAT	yield)	positive	blood	donors	to	determine	genotypes	and	drug	
resistance	(where	applicable)	of	donor	infections.	
Specific	Aims	of	Risk	Factor	Assessment		
	
1)	Determine	current	behavioral	risk	factors	associated	with	all	HIV-infected	donors,	and	HCV	and	HBV	
NAT	yield	donors,	including	parenteral	and	sexual	risks,	across	the	participating	blood	collection	
organizations.		
	
Hypotheses:	
The	distribution	of	risk	factors	for	viral	infections	in	donated	blood	reported	by	donors	in	studies	
from	more	than	10	years	ago	will	not	be	same	as	those	reported	today.	We	expect	that	factors	
such	as	injection	drug	use	will	comprise	a	lower	proportion	of	identified	risk	in	blood	donors	

8	

with	infections,	and	those	sexual	exposures,	including	multiple	heterosexual	partners	(MHP)	and	
male-to-male	sex	(MSM),	will	comprise	a	larger	proportion	of	reported	risks	for	infection.		
	
2)	Analyze	integrated	risk	factor,	recency	and	genotype	data	together	because	when	taken	together	
these	may	show	that	blood	centers	are	not	achieving	the	same	degree	of	success	in	educational	efforts	
to	prevent	donation	by	donors	with	risk	behaviors	across	all	demographic	groups.		
	
The	primary	contribution	this	project	can	add	to	a	national	biovigilance	system	is	to	monitor	routes	and	
rates	of	viral	infection	acquisition	that	could	lead	to	transfusion	transmission.	Thus	results	from	this	
study	could	also	be	used	to	assist	in	formulating	guidelines,	informing	policy	decisions,	planning	
prevention	programs,	and	targeting	risk	reduction	interventions.	National	reporting	systems	with	
coordinated	collection	and	analysis	of	data	have	led	to	specific	recommendations	that	underpin	key	
transfusion	safety	initiatives	in	other	jurisdictions.20	
	
	
	

9	

Study	Procedures	and	Tasks	
	
Study	Population		
	
The	study	population	for	the	risk	factor	interviews	will	be	allogeneic	and	directed	donation	blood	donors	
from	the	four	participating	blood	centers	who	have	specific	screening	results	obtained	from	routine	
donation	screening	from	either	ARC	or	Creative	Testing	Solutions	(CTS)	laboratories.		
	
Inclusion	Criteria	
	
Donors	eligible	to	be	interviewed	for	the	risk	factor	study	as	part	of	LRCC	activities	will	be	donors	who	
have	confirmed	HIV,	HCV	NAT	yield,	or	HBV	NAT	yield	infections	and	donors	who	test	repeat	reactive	
but	do	not	confirm	positive	based	on	confirmatory	testing.	Table	3	provides	the	types	of	each	confirmed	
positive	viral	infection	that	will	qualify	as	eligible	cases	for	risk	factor	interviews.		
	
Defining	Infection	Status	
	
Consensus	Positive	Donors	
	
The	Donation	Database	Coordinating	Center	(DDCC)	portion	of	TTIMS	includes	development	and	use	of	
interpretation	algorithms	to	consistently	define	infections	based	on	routine	testing	at	ARC	or	CTS.	NAT	
yield	donors	are	considered	incident	infections	versus	those	of	HIV	seropositive	donors	where	the	time	
of	infection	acquisition	is	unknown	using	standard	laboratory	screens.	Testing	conducted	as	part	of	LRCC	
Protocol	2	will	be	used	to	further	classify	seropositive	HIV	infections	into	recent	or	long-standing	status.	
	
	
	

10	

Table	3.	Summary	of	consensus	positive	definitions	for	HIV,	HCV,	and	HBV	cases	used	to	define	eligible	
donors	for	risk	factor	interviews	as	cases.	
Donation	Test	Results	
Study	Definition	
	
HIV	
	
	
NAT-yield	
• Anti-HIV	nonreactive	(NR)	and		
(Incident	HIV)	
• HIV	NAT-discriminated	reactive	(dHIV)	and		
• HIV	NAT-discriminated	reactive	(dHIV)	in	an	independent	
sample	(e.g.	retrieved	plasma	component)	or	confirmed	HIV	
NAT-reactive	with	or	without	anti-HIV	seroconversion	in	a	
donor	follow-up	sample	
Seroreactive	+	NAT-reactive	
• Anti-HIV	repeat	reactive	(RR)	and		
(Prevalent	HIV)	
• HIV	NAT-discriminated	reactive	(dHIV)	
Seroreactive	+	low-level	
• Anti-HIV	repeat	reactive	(RR)	and		
viremia	or	virologic	control	
• HIV	MP-NAT	NR	and	
(Prevalent	HIV)	
• Anti-HIV	confirmed	reactive	(IFA,	EIA,	WB,	ChLIA)	in	an	
independent	sample	(e.g.	retrieved	plasma	component)	
Note:	10x	replicate	testing	with	at	least	1	reactive	on	dHIV	
NAT	required	to	define	as	HIV	controller	
	
HCV	
NAT-yield	
• Anti-HCV	nonreactive	(NR)	and		
(Incident	HCV)	
• HCV	NAT-discriminated	reactive	(dHCV)	and		
• HCV	NAT-discriminated	reactive	(dHCV)	in	an	independent	
index	donation	sample	(e.g.	retrieved	plasma	component)	or	
confirmed	HCV	NAT-reactive	with	or	without	anti-HCV	
seroconversion	in	a	donor	follow-up	sample	
	
HBV	
NAT-yield	
• Anti-HBV	nonreactive	(NR)	and		
(Incident	HBV)	
• HBV	NAT-discriminated	reactive	(dBIV)	and		
• HBV	NAT-discriminated	reactive	(dHBV)	in	an	independent	
sample	(e.g.	retrieved	plasma	component)	or	confirmed	HBV	
NAT-reactive	with	or	without	anti-HBV	seroconversion	in	a	
donor	follow-up	sample	
	
	
Exclusion	Criteria	
	
Donors	with	results	from	any	blood	donation	not	meeting	the	specific	testing	results	defined	in	Table	3	
will	not	be	eligible	for	risk	factor	interviews	as	cases.	Autologous	donors	meeting	these	infection	
definitions	are	not	eligible.		
	
	

11	

False-Positive	Donors	
	
Robust	confirmation	procedures	are	used	to	ensure	donors	who	are	repeat	reactive	on	one	of	the	
screening	tests,	but	negative	on	all	others,	are	verified	by	further	supplemental	testing	to	be	falsepositive.	These	donors	are	not	the	same	as	donors	who	are	classified	as	having	indeterminate	testing	
results.21	Donors	with	indeterminate	confirmation	results	will	not	be	eligible	as	controls	for	TTIMS.	
Donations	from	donors	who	test	repeat	reactive	but	are	not	confirmed	by	supplemental	testing	are	
believed	to	be	random	events	and	therefore	they	represent	an	appropriate	sample	of	the	blood	donor	
population.	Studies	of	infected	and	uninfected	blood	donors	have	previously	used	this	strategy	to	
identify	controls	for	case-case	control	studies2,22-24	and	research	has	shown	that	donors	with	falsepositive	results	on	an	initial	screening	test	are	not	infected.25-27	A	recent	study	has	suggested	that	some	
false-positive	test	results	for	HTLV	and	HCV	may	be	associated	with	certain	demographics,	but	for	antiHIV	or	HBsAg	false-positive	results	no	demographic	associations	were	evident.28			
	
For	TTIMS,	we	will	use	anti-HIV	screening	false-positive	donors	as	controls	for	all	HIV	cases.	The	
frequency	of	false-positive	testing	results	varies	according	to	the	sensitivity	and	specificity	and	other	
aspects	of	the	screening	tests	used.	For	anti-HIV	testing	the	ratio	of	false-positive	to	confirmed	positive	
donors	is	greater	than	15:1.	This	ratio	means	that	we	will	have	far	more	false-positive	donors	than	
confirmed	positive	donors	as	potential	participants	for	the	study.	Similarly,	HBsAg	false-positive	are	
straightforward	to	confirm	as	uninfected	and	will	serve	as	an	additional	source	of	potential	controls.	Use	
of	donors	with	HBsAg,	non-neutralized,	false-positive	donations	is	of	particular	relevance	to	serve	as	
controls	for	incident	[serology	negative,	nucleic	acid	test	positive	(NAT	yield)]	HBV	and	HCV	cases.				
	
The	operational	processes	that	are	used	for	blood	screening	results	notification	for	false-positive	donors	
represent	an	opportunity	to	sample	an	informative	control	group	that	has	interacted	with	each	blood	
center	in	a	largely	similar	manner	to	that	of	cases.	These	donors	are	contacted	by	mail	informing	them	
of	the	results	of	testing	and	their	false-positive	status.	Because	they	have	to	be	contacted	and	provided	
the	results,	which	include	the	false-positive	screening	tests,	these	donors	may	be	interested	and	
motivated	to	complete	the	questionnaire	as	part	of	the	counseling	process	even	though	they	do	not	
have	infection.	In	the	REDS-II	Risk	Factor	Study,	enrollment	of	false-positive	donors	for	control	
interviews	was	readily	achieved.		
	
Control	interviews	will	be	conducted	using	the	same	study	procedures	as	planned	for	case	interviews	
with	each	blood	center	interviewing	its	own	donors	by	telephone	using	the	internet-based	survey,	and	
the	web-based	study	management	system.	Controls	would	be	interviewed	in	years	2	through	5	of	the	
TTIMS	program,	but	would	be	enrolled	in	numbers	to	reflect	an	overall	1:2	case:control	ratio	for	the	
entire	TTIMS	project	period,	i.e.	the	total	number	of	cases	for	the	5	year	period	will	be	used	to	conduct	
control	interviews	to	achieve	a	final	1:2	ratio.		
	
	
	

12	

Donor	Enrollment	and	Study	Management	
	
General	Approach	
	
The	reports	of	confirmed	infections	(HIV	NAT	yield	and	seropositive	and	HCV	and	HBV	NAT	yield)	and	
false	positive	donors	provided	to	each	blood	center	by	the	DDCC	will	also	be	sent	to	the	LRCC	and	will	
serve	as	the	denominator	data	of	consensus	eligible	donors	for	LRCC	activities.		
	
First,	we	will	use	a	system	internal	to	the	LRCC	that	will	not	be	accessible	by	other	organizations	for	the	
purpose	of	tracking	completion	of	each	aspect	of	LRCC	project	procedures	for	each	qualifying	consensus	
eligible	donor.	The	DDCC	consensus	eligible	donor	reports	data	will	be	entered	into	an	activity	tracking	
database	at	Blood	Systems	Research	Institute	(BSRI).	We	are	not	planning	to	maintain	TTIMS	data	in	this	
BSRI-internal	activity	tracking	log,	but	rather	we	will	use	it	as	the	record	of	LRCC	tasks	for	each	
participant	and	specimen	set.	BSRI	will	use	these	data	with	the	donation	identification	number	(DIN)	as	
the	key	unique,	but	de-identified,	tracking	identifier	to	establish	a	sample	and	participant	tracking	log.		
	
Second,	a	study	management	system	(SMS)	will	be	developed	that	will	be	used	by	each	blood	center	to	
monitor	recruitment,	consent,	enrollment,	provision	of	incentives	and	communication	of	relevant	
results	back	to	each	participant.	Through	BSRI’s	affiliation	with	UCSF,	we	will	use	the	study	management	
software	Online	Collaborative	Research	Environment	(OnCore,	Forte	Research	Systems,	Madison,	WI).	
This	is	a	state-of-the-art	study	management	system	software	package	capable	of	tracking	activities	
related	to	donors	(recruitment,	consent,	enrollment,	completion	of	study	activities,	provision	of	
participation	incentives),	specimens	(receipt	of	specimens,	provision	to	specific	testing	laboratories,	
indication	of	completed	testing),	and	can	be	used	to	generate	summary	reports	of	each	of	these	
activities.		For	the	SMS	we	will	utilize	a	specific	component	of	the	OnCore	platform,	the	Unified	
Registries	Management	(URM)	system	to	guide	study	procedures	at	each	site	and	to	monitor	progress.	
This	is	a	customizable	set	of	study	and	participant	tracking	tools	that	will	serve	as	the	SMS	for	LRCC.	The	
OnCore	URM	module	enables	management	of	clinical	research	data	sets	that	are	configured	around	an	
event	(e.g.,	a	blood	donation)	and	the	ability	to	create	a	coordinated	cascade	of	data	capture	at	the	
person	or	event	level,	including	deployment	of	common	forms	for	all	participating	blood	centers	and	
data	export	tools	for	analysis	in	statistical	programs.		
	
The	OnCore	system	will	be	implemented	in	accord	with	all	required	data	security	and	privacy	
protections,	and	current	standard	best	practices.	Outside	of	the	OnCore	URM,	each	site	will	have	access	
to	donor-specific,	personally	identifying	information	(PII)	that	the	LRCC	will	not	have	access	to.	PII	will	be	
maintained	by	each	blood	center	per	standard,	regulated	procedures.	These	data	will	be	accessed	by	
LRCC	project	staff	within	each	center	for	the	purpose	contacting	and	recording	completion	of	TTIMS	
LRCC	project	activities.		
	
Within	the	OnCore	URM,	access	levels	for	all	study	staff	are	controlled	by	LRCC	senior	staff	based	on	job	
function.	At	the	donor	level,	the	data	captured	will	include	recruitment	status	(e.g.,	consented,	refusal,	
pending,	lost	to	follow-up),	risk	factor	interview	completed,	and	participation	incentive	provided.	At	the	
donation	or	sample	level	the	data	captured	will	include	an	indicator	of	successful	retrieval	of	the	frozen	
plasma	unit	from	the	index	donation,	bio-specimens	obtained	from	plasma	unit	or	from	alternate	
sources,	specimens	accessioned	into	the	repository,	recency	testing	completed,	and	molecular	
surveillance	testing	completed.		
	
13	

The	LRCC	will	create	a	centralized	repository	of	samples	from	consensus	HIV-positive,	HCV	NAT	yield,	
and	HBV	NAT	yield	blood	donations	to	serve	future	research	uses	such	as	availability	for	HIV,	HCV,	and	
HBV	evolutionary	geneticists	investigating	changes	in	virulence	and	pathogenicity	over	time.	These	
mechanisms	for	obtaining	additional	specimens	shall	be	ready	for	implementation	to	capture	other	
specimens	if	an	emerging	agent	of	concern	is	identified.	The	repository	is	described	in	Protocol	2.	
	
Control	donor	interviews	will	be	based	on	a	random	sample	of	anti-HIV,	or	HBsAg	false	positive	donors	
in	a	ratio	of	1	case	to	2	controls	within	each	blood	collection	organization.		
	
Description	of	LRCC	Activities	
	
The	LRCC	will	use	reports	developed	by	the	DDCC	subcontractor,	Quality	Analytics,	to	initially	identify	
those	potential	donors	who	are	eligible	for	participation	in	the	LRCC	portion	of	TTIMS.	The	diagram	
titled	Transfusion	Transmissible	Infections	Monitoring	System	(TTIMS),	Donation	Database	Coordinating	
Center	(DDCC)	and	Laboratory	and	Risk	Factor	Coordinating	Center	(LRCC)	maps	out	the	data	and	
specimen	flow	that	will	be	used	to	conduct	blood	center	specific	activities	under	the	LRCC	(Appendix	1).	
Communication	of	all	study-related	data	files	will	occur	via	secure	channels	(username	and	password	
protected	computers,	secure	file	transfer	protocols	(FTP),	and	as	required	per	the	terms	of	the	contract	
will	use	Secure	Sockets	Layer	(SSL)	and	Transport	Layer	Security	(TLS)	or	encrypted	SSL/TLS	connections).		
	
The	approach	to	identifying	eligible	cases	will	be	driven	by	data	directly	obtained	from	donation	testing	
by	ARC	and	CTS.	ARC	and	CTS	testing	data	will	be	provided	according	to	donation	identification	numbers	
(DINs)	and	will	be	electronically	transferred	to	the	DDCC	data	server,	as	described	in	the	TTIMS	DDCC	
Protocol.	These	data	will	define	HIV,	HBV,	and	HCV	consensus	positives.	Quality	Analytics	will	use	the	
consensus	infectious	marker	testing	algorithms	developed	for	this	project	and	will	run	interpretation	
programs	to	define	which	combinations	of	test	results	meet	the	required	study	eligibility	definitions.	
These	reports	will	then	be	sent	back	to	each	participating	blood	center	organization	and	to	CTS	by	DIN,	
and	will	serve	as	the	list	uses	to	retrieve	plasma	units	(if	available),	residual	volumes	from	testing	and	for	
the	recruitment	of	risk	factor	interview	participants.	This	process	removes	the	need	for	local	blood	
center	IT	expertise	in	running	these	algorithms	and	will	ensure	that	eligible	donors	are	defined	in	the	
same	across	all	participating	sites.	BSI,	NYBC,	and	OneBlood	testing	results	will	be	provided	to	the	DDCC	
by	CTS.	Similarly,	ARC	data	will	be	provided	to	the	DDCC	by	ARC	testing	laboratories.	The	data	will	flow	
to	the	DDCC	data	server	separately,	but	in	parallel	from	CTS	and	ARC	testing	labs.	
	
The	LRCC	will	coordinate	and	facilitate	the	activities	that	individual	blood	centers	will	use	for	recruiting,	
enrolling	and	characterizing	risk	behaviors	in	seroprevalent	and	NAT	yield	HIV	blood	donors	and	NAT	
yield	HCV	and	HBV	blood	donors.	Donors	with	false-positive	results	will	also	be	enrolled.	Donor	
counselors	at	participating	blood	centers	will	conduct	risk	factor	interviews.	Each	blood	center	will	be	
responsible	for	recruiting	its	own	blood	donors,	enrollment	of	these	donors,	conducting	the	web-based	
risk	factor	interview,	and	working	with	ARC,	CTS,	and	BSRI	to	provide	plasma	specimens	for	the	
repository	and	testing	at	the	LRCC.	
	
The	four	participating	blood	centers	in	LRCC	estimate	they	have	the	following	annual	number	of	
infections	that	will	qualify	for	LRCC	activities	(Table	4).		
	
14	

Table	4.	Annual	estimates	of	donors	with	infections	that	will	qualify	for	TTIMS	participation.	
Blood	Center	
Serology	+	NAT	
HIV	NAT	yield	 HCV	NAT	yield	 HBV	NAT	yield	
HIV	Positive	
ARC	
150	
20	
50	
20	
BSI	
24	
1	
4	
1	
NYBC	
22	
1	
4	
3	
OneBlood	
64	
1	
35	
11	
Total	
260	
23	
93	
35	
After	routine	notification	of	having	donated	a	confirmed	HIV-positive	donation,	HCV	NAT	yield,	or	HBV	
NAT	yield,	donors	will	be	asked	to	complete	an	interviewer-administered	telephone	questionnaire.	The	
LRCC	will	build	on	current	operational	procedures	to	facilitate	the	ease	of	use	of	the	risk	factor	interview	
instrument.	As	per	operational	procedures,	except	in	rare	circumstances,	donors	who	are	HIV	positive	
are	notified	in	person	by	blood	center	professional	medical	staff	(physician	or	qualified	donor	counselor)	
and	will	be	asked	to	complete	the	questionnaire	at	the	time	of	notification,	or	based	on	professional	
judgment	at	a	future	in-person	meeting	or	by	telephone	call	if	agreement	for	future	contact	is	obtained.	
Donors	with	false	positive	test	results	will	be	contacted	in	the	same	manner.	Trained	donor	counselors	
will	conduct	the	interview	over	the	telephone.	There	are	strict	operational	procedures	at	all	blood	
centers	in	place	to	verify	that	a	person	contacted	by	phone	is	the	donor.	If	the	donor’s	identity	cannot	
be	confirmed	via	standard	operational	procedures	the	interview	will	not	be	conducted.	Donor	
counselors	will	try	to	contact	donors	by	phone	to	follow-up	to	see	if	the	donor	received	the	routine	
notification	letter	and	counseling	materials.	Donor	counselors	will	attempt	to	contact	donors	up	to	3	
times	by	phone,	email,	or	letter.	If	counselors	are	unable	to	reach	a	donor	after	3	attempts	the	donor	
will	be	classified	as	lost	to	follow-up.	Study	information	mailer	templates	in	English	and	Spanish	are	
provided	in	Appendices	5	and	6.	The	LRCC	will	work	with	each	blood	center	to	include	the	project	
information	mailer	as	part	of	the	notification	letter	sent	to	donors	who	are	eligible	for	interview.	
Although	each	organization	will	seek	to	enroll	all	persons	who	meet	the	study	case	definitions,	it	is	
unrealistic	to	expect	100%	participation.	We	will	strive	to	achieve	no	less	than	50%	and	target	75%	
participation	as	our	enrollment	goal	for	each	qualifying	consensus	definition	donor.	We	believe	the	
provision	of	a	$75 participation	incentive	to	each	donor	who	consents	and	completes	the	risk	factor	
interview	may	be	very	helpful	in	reaching	the	target	participation	proportion.	Total	potential	enrollment	
per	year	is	provided	in	Table	5.		Importantly,	year	1	enrollment	will	likely	be	lower	than	in	subsequent	
years	because	risk	factor	interviews	for	the	first	year	will	mostly	be	conducted	retrospectively	following	
Office	of	Management	and	Budget	(OMB)	clearance	to	interview	donors.	An	enrollment	of	less	than	50%	
in	the	first	year	is	likely	the	maximum	that	will	be	achievable	due	to	the	elapsed	time	before	we	can	
contact	donors	for	interviews	and	the	associated	likely	increased	loss	to	follow-up	because	of	potentially	
out	of	date	contact	information	at	the	time	we	seek	to	recruit	study	participants.		

15	

Table	5.	Annual	estimates	of	donor	risk	factor	interviews	based	on	different	assumed	participation	
proportions.	
Assumed	
participation	of	
Serology	+	NAT	
donors	with	
HIV	NAT	yield	 HCV	NAT	yield	 HBV	NAT	yield	
HIV	Positive	
confirmed	
infection	
100%	
260	
23	
93	
35	
75%	
195	
17	
70	
26	
50%	
130	
12	
47	
18	

Assessment	and	Measurement	Procedures	
The	LRCC	will	use	similar	study	procedures	to	those	from	the	REDS-II	DRFS	study	to	compile	risk	factor	
data	for	all	qualifying	HIV	infections	and	HCV/HBV	NAT	yield	infections	across	different	blood	collection	
organizations.	Because	TTIMS	requires	both	consistency	and	timeliness	in	capturing	risk	factor	
responses,	interviewer	administered	questionnaires	will	be	performed.	This	also	creates	an	opportunity	
for	donor	counselors	to	provide	additional	counseling.	Interviews	will	be	electronically	transferred	to	the	
LRCC	as	part	of	a	consolidated	database	of	all	completed	interviews.	Data	form	scanning	or	key	punch	
entry	will	not	be	necessary.	The	LRCC	will	conduct	quality	control	and	assurance	processes	that	include	
allowed	and	out-of-range	values;	interview	quality	control	reports	will	be	generated	and	provided	back	
to	each	blood	center	on	a	monthly	basis	to	check	and,	where	necessary,	correct	and	resubmit	updated	
interviews.	The	DDCC	overall	database	for	TTIMS	will	serve	a	similar	role	as	in	the	previous	REDS-II	
Marker	Prevalence	and	DRFS	by	allowing	additional	cross-checking	of	some	types	of	donor-reported	
information.	For	example,	self-reported	first-time	or	repeat	donor	status	is	difficult	to	verify,	therefore	
we	will	rely	on	blood	center	records	to	determine	first-time	or	repeat	donor	status.	These	blood	center	
data	are	more	reliable	than	donor	self-reported	information.				
Although	not	specifically	relevant	to	LRCC	Protocol	1,	the	LRCC	will	coordinate	with	the	DDCC	and	
participating	blood	collection	organizations	regarding	collection,	tracking,	shipping	(including	freight),	
storage,	and	retrieval	of	all	biospecimens	for	lab	characterizations.	The	primary	path	by	which	we	will	
achieve	coordination	with	the	DDCC	will	be	through	the	“Numerator	Test	Data”	reports	provided	to	
each	blood	center	and	BSRI	for	the	purpose	of	tracking	information	(Appendix	1).	This	information	will	
be	integrated	into	the	SMS	so	that	bio-specimen	and	participant	tracking,	as	well	as	availability	of	results	
from	interviews	and	testing	are	traceable	in	monitoring	reports.	Each	participating	blood	center	will	
have	access	to	only	data	from	its	own	donors	and	not	to	that	of	other	centers.	
The	unique	identifier	to	be	used	in	this	study	is	ISBT	128	DIN.	
The	DIN	is	the	ISBT	128	term	used	to	identify	the	specific	unit	number	assigned	to	a	particular	donation.	
The	DIN	is	composed	of	three	data	elements	structured	in	a	way	that	allows	each	collection	to	be	
globally	unique.	For	example,	this	prevents	hospitals	from	receiving	duplicate	unit	numbers,	originating	
from	multiple	locations.	DIN	is	not	linkable	to	any	other	records	except	by	the	blood	collection	
organization	where	the	donation	was	given	and	the	DIN	was	assigned.	
16	

Risk	Factor	Survey	Administration	
	
Each	organization,	ARC,	BSI,	NYBC,	and	OneBlood,	will	interview	its	own	donors.	The	LRCC	will	
coordinate	and	train	blood	centers	in	conducting	risk	factor	interviews	by	donor	counselors	via	
telephone.	A	tailored	plan	will	be	developed	for	each	site	based	on	language	administration	capability	
(i.e.	Spanish-language	capability	or	English-only).	The	risk	factor	interview	is	targeted	to	be	conducted	
within	30-days	of	the	date	the	index	donation	is	confirmed	to	meet	TTIMS	eligibility	definitions	(once	
prospective	interviewing	is	approved	by	OMB	and	IRBs,	and	training	is	completed).	
	
BSRI	is	a	UCSF	affiliate	and	as	such	has	access	to	the	web-based	survey	data	collection	software	
program,	Qualtrics™	(Qualtrics,	Provo,	UT).	Data	collected	using	the	web-based	interviews	are	stored	on	
Qualtrics	servers	in	AZ,	CO,	and	UT	but	can	be	downloaded	at	any	time	(multiple	formats,	Stata,	SAS,	
Excel,	CSV,	PDF,	etc.).	The	survey	tool	will	be	designed	to	automatically	email	or	print	out	individual	
survey	responses	at	the	completion	of	the	interview.	Printed	copies	will	be	kept	by	each	blood	center.	In	
addition,	the	software	can	also	be	programmed	to	send	the	output	to	a	designated	person	upon	survey	
completion	or	at	set	intervals.	The	LRCC	will	use	this	feature	to	collect	the	survey	data	in	the	project	
database	as	soon	as	each	interview	is	finished.		
	
For	the	purpose	of	administration	of	risk	factor	interviews,	all	LRCC	project	staff	will	access	the	
electronic	survey	using	individually	defined	usernames	and	passwords	that	will	be	provided	by	UCSF	IT	
Services.	Access	will	be	granted	or	revoked	by	BSRI	and	UCSF.	The	coordinators	and	donor	counselors	
will	access	the	interview	form	via	a	permanent	hyperlink	and	create	a	new	record	by	entering	data	for	a	
new	participant	using	the	DIN	as	the	study	subject	number.		
	
A	risk	factor	questionnaire	has	been	developed	that	focuses	on	the	risk	behaviors	associated	with	
human-to-human	transmission	of	viral	infections	for	which	blood	centers	universally	screen	donated	
blood	(English	and	Spanish	versions	included	as	Appendices	8	and	9).	The	ability	to	ask	questions	about	
all	three	viruses	on	a	single	instrument	is	feasible	since	infected	individuals	often	share	risk	factors	for	
routes	of	virus	acquisition.		Although	the	risk	of	transmission	varies	for	each	virus,	HBV,	HCV,	and	HIV	
can	all	be	acquired	through	the	following	routes:	parenteral	(examples:	blood	or	blood	product	
transfusion,	transplantation,	injection	drug	use,	tattooing,	body	piercing,	needle	stick	injury),	sexual,	
perinatal	(examples:	during	pregnancy,	labor,	delivery	or	breastfeeding),	and	household	contact	
(examples:	sharing	toothbrushes	or	razor	blades	with	an	infected	individual).	These	routes	of	acquisition	
and	risk	factors	have	all	been	previously	identified	in	the	literature	and	are	considered	to	be	wellestablished.4,14,29-32	Our	study	is	designed	to	assess	the	frequency	of	these	routes	of	self-reported	
infection	acquisition.	The	study	is	not	designed	to	assess	very	rare	or	newly	hypothesized	routes	of	
infection	acquisition.	
	
We	estimate	that	it	will	take	5	minutes	time	to	complete	verbal	informed	consent,	the	questionnaire	will	
require	approximately	40	minutes	of	the	donor’s	time.		The	instrument	has	been	developed	with	skip	
patterns	so	that	the	time	of	administration	may	vary	substantially	based	on	the	risk	behaviors	of	
different	donors.	Donors	will	be	interviewed	by	counselors	who	are	employed	by	the	organization	
where	the	donor	gave	blood.	Interviews	will	be	conducted	in	English	or	Spanish	based	on	the	preference	
stated	by	each	donor	and	site	capability.	Consent	will	be	obtained	in	the	same	language	as	the	
interview.	Data	from	completed	questionnaires	from	all	four	participating	organizations	will	be	collected	
in	a	secure	database	managed	by	BSRI.	BSRI	researchers	will	not	have	access	to	the	names	or	any	other	
personally	identifying	information,	except	biometric	identifiers.		
	
17	

	
Analyses	and	Reporting	
	
The	OnCore	study	management	system	is	designed	to	keep	track	of	the	route	of	study	subject	contact,	
including	capturing	basic	demographic	information	on	donors	whom	we	contact,	those	who	refuse	to	
participate	and	those	we	are	unable	to	contact	following	recruitment	efforts	(classification	categories	
will	include;	enrolled,	refused,	pending,	unable	to	contact,	lost	to	follow-up,	interview	complete).	This	
information	will	be	analyzed	to	assess	whether	demographic	differences	are	evident	for	donors	who	
participate	compared	to	donors	who	refuse	or	are	lost-to	follow-up.	
	
The	LRCC	will	establish	ongoing	data	analysis	capabilities	to	evaluate	and	monitor	results	obtained	from	
risk	factor	interviews,	recency	testing,	and	genotype	and	drug	resistance	testing.	Prevalence	and	
incidence	trends	will	be	primarily	monitored	by	the	DDCC.	Stratified	analyses	will	be	conducted	by	the	
LRCC	using	information	captured	from	the	confirmed	case	listings	provided	by	the	DDCC	to	each	center	
and	to	the	LRCC	as	well	as	the	additional	data	collected	from	risk	factor	interviews.			
	
Risk	factor	analyses	will	include	overall	analyses,	as	well	as	comparison	of	results	to	centers	that	fully	
participated	in	the	REDS-II	study	(ARC,	BSI	and	NYBC).	This	will	enable	us	to	compare	the	risk	behavior	
proportions	for	HIV	infection	observed	in	TTIMS	to	those	determined	during	the	REDS-II	DRFS,	i.e.,	to	
the	proportions	of	donors	with	HIV	that	reported	IDU,	MSM	or	MHP.	We	will	assess	whether	the	
proportion	of	infection	attributable	to	each	risk	behavior	is	approximately	the	same	or	different	from	
those	observed	previously.	The	comparison	of	risk	factors	for	new	HBV	and	HCV	infections	will	also	be	
possible,	but	given	small	numbers	of	NAT	yield	infections,	it	is	unlikely	quantitative	statistical	
comparisons	can	be	achieved.		
	
The	analysis	and	reporting	of	results	to	the	TTIMS	Steering	Committee	(SC)	and	FDA	will	be	delayed	by	at	
least	a	month	following	the	close	of	a	quarter	in	order	to	allow	sufficient	time	for	quality	control,	
cleaning	and	analysis	of	information.	The	one	month	delay	following	the	close	of	a	quarter	is	important	
to	be	confident	the	data	are	as	complete	and	accurate	as	possible.		The	planned	report	content	and	
reporting	periods	are:	
	
A. Quarterly	reports	(based	on	achieved	enrollment	and	completed	testing	at	the	close	of	the	quarter)		
1. For	each	type	of	viral	infection:	
a. Number	of	completed	interviews	in	the	quarter	by	center	and	overall	
b. Frequency	tables	of	age,	gender,	race/ethnicity,	first-time	or	repeat	status,	DHHS	public	
health	region,	and	donation	type	of	interviewed	donors	
c. Frequency	tables	of	reported	risk	factors	
2. Results	of	HIV	recency	testing	(once	LRCC	Protocol	2	is	implemented)	
a. Frequency	tables	of	HIV	recency	results	by	the	same	categories	listed	in	A.1.b	
3. Frequency	tables	of	combined	analyses	of	recent	infections	and	risk	factors	
	
B. Semi-annual	reports	(based	on	achieved	enrollment	and	completed	testing	at	the	close	of	the	semiannual	period)	
1. Genotype	results	for	HIV,	HCV,	and	HBV	and	drug	resistance	results	for	HIV	and	HBV	
2. Frequency	tables	of	combined	analyses	of	recent	infections,	risk	factors,	and	genotypes	for	each	
of	the	three	viruses	
18	

3. Separate	frequency	tables	of	risk	factors	in	HIV	NAT	yield	infections	
Triggered	Follow-up	Investigations	
	
The	LRCC	will	coordinate	with	the	DDCC	and	participating	blood	collection	organizations	to	conduct	
follow-up	investigations	triggered	by	significant	changes	in	TTI	incidence/prevalence	rates	and	risk	
factors,	as	defined	by	consensus	agreement	between	FDA	and	the	TTIMS	SC.	One	approach	might	be	to	
rely	on	95%	Confidence	Intervals	calculated	on	quarterly	or	semi-annual	datasets.	If	the	95%	confidence	
intervals	for	incidence,	prevalence	and	risk	factor	frequencies	are	non-overlapping	this	may	represent	
evidence	of	“significant	changes”.	Even	so,	some	random	variability	is	expected	in	all	of	these	data,	and	
so	an	alternate	approach	could	be	to	conduct	trend	analyses	by	month	or	quarter	to	assess	the	
possibility	of	sustained	change.	The	shorter	the	period	the	data	are	compared,	the	higher	the	likelihood	
of	variability	that	could	appear,	but	is	not	in	fact	significant.	Ultimately,	the	TTIMS	SC	using	the	data	that	
have	been	provided	by	DDCC	and	LRCC	activities	will	determine	if	an	investigation	is	required.		
	
If	an	investigation	is	prompted,	the	investigation	will	include	verifying	that	the	processes	of	donor	and	
donation	qualification	for	each	blood	establishment	participating	in	LRCC	have	been	performed	in	
accordance	with	FDA	regulations,	cGMP	and	all	standard	operating	procedures	of	the	blood	
establishment.		This	also	includes	adhering	to	all	manufacturers’	instructions,	acting	on	all	information	
provided	by	the	donor	at	the	time	of	donation	and	any	additional	information	provided	by	the	donor	
post-donation	(e.g.,	disclosure	of	any	high-risk	behavior).	These	investigations,	should	they	be	triggered,	
will	be	conducted	within	30	days	of	their	identification.	
Statistical	Considerations	
	
Power	and	Sample	Size	
	
Power	analyses	to	help	guide	the	understanding	of	what	levels	of	excess	risk	can	be	estimated	assuming	
a	case	to	control	ratio	of	1:2	with	50%	case	enrollment	was	conducted	and	the	expected	number	of	HIV,	
HCV	and	HBV	cases	during	the	TTIMS	period	was	conducted.	The	detailed	results	from	the	REDS-II	Study	
(Appendix	2)	provide	information	on	the	prevalence	of	risk	behaviors	reported	by	HIV,	HCV	and	HBV	
cases	and	false-positive	controls	from	that	study.		In	addition,	a	survey	study	of	undisclosed	risk	factors	
in	accepted	male	donors	conducted	as	part	of	REDS-III,	found	non-compliance	with	the	MSM	deferral	in	
uninfected	male	blood	donors	of	2.6%.19		For	HIV,	we	assume	a	maximum	expected	prevalence	of	
undisclosed	risks	in	the	control	group	during	TTIMS	based	on	these	recent	data.	Power	to	detect	
significant	associations	depending	on	the	excess	risk	in	cases	and	the	baseline	prevalence	of	each	
behavior	in	controls	with	a	sample	size	of	710	confirmed	HIV-positive,	interviewed	donors	compared	to	
1420	interviewed	controls	is	provided	in	Table	6.	The	table	shows	the	power	at	α=0.05	to	detect	
significant	associations	between	risk	factors	with	a	prevalence	of	2.6,	1.7,	0.5	and	0.25%	in	controls	
donors	assuming	10,	5,	3,	and	2-fold	higher	odds	of	specific	risk	behaviors	in	confirmed-positive	donors.		
	
To	place	these	estimates	in	context,	we	will	have	sufficient	power	to	detect	odds	ratios	just	above	2-fold	
higher	for	any	behavior	reported	by	2.6%	of	controls.	In	addition,	although	the	adjusted	odds	ratio	in	the	
REDS-II	study	was	3.1	for	the	association	between	HIV	infection	and	intravenous	drug	use	(IDU),	it	was	
not	statistically	significant.	In	that	study	0.4%	of	false-positive	controls	reported	IDU.	With	the	proposed	
number	of	controls	we	will	have	sufficient	power	to	detect	an	odds	ratio	of	5	or	higher	for	IDU	if	0.5%	of	
19	

controls	report	IDU	history.	Overall,	the	proposed	ratio	of	cases	to	controls	for	HIV	in	TTIMS	will	be	able	
to	achieve	similar	power	levels	as	achieved	in	the	REDS-II	study.		
	
Table	6.	Power	for	various	risk	factor	prevalence	combinations	for	HIV	cases	compared	to	controls,	
assuming	50%	case	enrollment	and	a	1:2	case:control	ratio.	
Infectious	Marker	
Prevalence	of	risk	
	
case/control	sample	 factor	in	controls	–	
Odds	ratio	to	detect	in	cases	
sizes	
[Reference]	
10	
5	
3	
2	
Power	
	
2.6%19	
1.0	
1.0	
1.0	
0.79	
HIV	
1.7%2	
1.0	
1.0	
0.97	
0.62	
710/1420	
0.5%	
1.0	
0.94	
0.58	
0.23	
0.25%	
0.99	
0.71	
0.33	
0.14	
	
The	inclusion	of	control	interviews	for	NAT-only	HCV	and	HBV	cases	will	increase	the	number	of	cases	
and	controls	over	the	five	year	period	to	a	projected	1030	and	2060,	respectively.	The	additional	560	
control	interviews	will	be	triggered	based	on	being	HBsAg	false-positive.	HBsAg	confirmation	testing	
when	non-neutralized	along	with	being	anti-HBc	and	NAT	negative	indicate	that	any	HBsAg	false-positive	
does	not	have	an	HBV	infection.	These	controls	would	be	informative	for	comparing	to	the	up	to	280	
NAT-only	HCV	and	HBV	infections	that	are	planned	to	be	interviewed	as	part	of	TTIMS.	Power	to	detect	
significant	associations	depending	on	the	excess	risk	in	cases	and	the	baseline	prevalence	of	each	
behavior	in	controls	with	a	sample	size	of	280	incident	HCV	and	HBV	confirmed	positive,	interviewed	
donors	compared	to	560	interviewed	controls	is	provided	in	Table	7.	The	table	shows	the	power	at	
α=0.05	to	detect	significant	associations	between	risk	factors	with	a	prevalence	of	5.2,	2.3,	0.5	and	
0.25%	in	controls	donors	assuming	10,	5,	3,	and	2-fold	higher	odds	of	specific	risk	behaviors	in	
confirmed-positive	donors.	The	estimates	are	based	on	risk	behaviors	that	were	significantly	associated	
with	HCV	or	HBV	infection	in	controls	from	the	REDS-II	Study;	5.2%	of	controls	from	that	study	reported	
spending	3	or	more	nights	in	jail,	detention	or	a	group	home,	and	2.3%	of	controls	reported	sex	with	an	
IDU.	
	
Table	7.	Power	for	various	risk	factor	prevalence	combinations	for	HCV	and	HBV	cases	compared	to	
controls,	assuming	50%	case	enrollment	and	a	1:2	case:control	ratio.	
Infectious	Marker	
Prevalence	of	risk	
	
case/control	sample	 factor	in	controls	–	
Odds	ratio	to	detect	in	cases	
sizes	
[Reference]	
10	
5	
3	
2	
Power	
	
5.2%	2	
1.0	
1.0	
0.98	
0.67	
2
HBV	&	HCV	
2.3%	 	
1.0	
1.0	
0.81	
0.38	
280/560	
0.5%	
0.96	
0.60	
0.27	
0.12	
0.25%	
0.76	
0.35	
0.16	
0.09	
	
For	the	assessment	of	the	association	between	IDU	and	incident	HCV,	we	will	be	able	to	estimate	a	
significant	odds	ratio	of	less	than	9	in	cases	compared	to	controls.	In	the	REDS-II	Study	the	association	
between	HCV	and	IDU	was	highly	significant	with	an	odds	ratio	of	42.		
	
For	other	uncommon	risk	behaviors	in	the	uninfected	population,	such	as	those	with	frequency	of	
0.25%,	if	all	interviewed	false-positive	donors	are	included	in	the	analysis	of	infection	risk	factors	2060	
20	

controls	can	be	compared	to	each	case	group.	If	this	is	done,	we	will	have	sufficient	power	(1-β	>	0.80)	
to	detect	odds	ratios	of	10	or	higher	in	cases.	Similarly,	we	will	have	sufficient	power	(1-β	=	0.80)	to	
detect	odds	ratios	of	5	or	higher	if	the	behavioral	prevalence	in	uninfected	donors	is	around	0.65%.		

Statistical	Analyses	
We	will	compute	descriptive	statistics,	such	as	frequencies	and	measures	of	central	tendency	(means	
and	medians)	in	order	to	characterize	the	infected	population	and	catalog	donor-reported	risk	factors	
likely	to	be	the	route	of	virus	acquisition	in	case	groups.	We	will	compare	the	risk	factors	reported	by	
donors	according	to	demographics	and	in	different	regions	of	the	country	to	determine	if	patterns	of	
infection	acquisition	vary	using	the	Chi-square	or	t-test	depending	on	the	structure	of	the	predictor	
variable	included	in	the	analysis.	Independently	for	each	virus,	univariable	and	multivariable	logistic	
regression	analysis	will	be	used	to	compare	risk	factors	when	the	outcome	variable,	infection	status,	can	
be	defined	in	a	dichotomous	manner.	For	example,	to	assess	the	association	between	risk	behaviors	and	
demographics	when	comparing	recently	acquired	HIV	to	long-standing	HIV	infection.	The	multivariable	
analyses	will	be	important	so	that	we	may	account	for	potential	confounding	with	regard	to	factors	such	
as	socio-economic	status	and	education	level.		
The	inclusion	of	controls	will	allow	for	more	advanced	statistical	analyses.	In	addition	to	descriptive	
statistics,	such	as	frequencies,	we	will	be	able	to	use	multivariable	logistic	regression	analysis	to	
compare	confirmed-positive	and	false-positive	donors	to	determine	the	association	between	risk	
behaviors,	while	adjusting	for	demographics,	Public	Health	Service	(PHS)	regions,	or	other	factors.	The	
multivariable	analysis	will	be	important	so	that	we	may	account	for	potential	differences	between	cases	
and	controls	with	regard	to	factors	such	as	socio-economic	status.	Furthermore,	advanced	exploratory	
analyses	may	also	be	possible,	such	as	multilevel	modeling	and	potentially	structural	equation	modeling.	
Use	of	these	techniques	could	generate	novel	interpretations	of	patterns	of	infection	in	blood	donors	
and	also	provide	for	a	more	direct	assessment	of	how	similar	or	dissimilar	infections	in	blood	donors	are	
to	the	larger	sets	of	data	on	infections	identified	through	other	public	health	surveillance,	and	higher	
risk	groups	surveillance.	These	analyses	will	allow	for	a	deeper	level	of	monitoring	of	the	data	from	
TTIMS	and,	if	other	public	health	datasets	can	be	accessed,	a	direct	comparison	to	other	sources.	
Examples	of	published	studies	using	these	techniques	show	there	is	potential	for	new	insights	if	these	
methods	are	applied	to	blood	donor	data.33-35		
Survey	Considerations	and	OMB	Requirements	
The	LRCC	will	develop	and	perform	standardized	risk	interview	survey(s),	in	accordance	with	
administrative	processes	such	as	review	and	approval	by	Institutional	Review	Boards	(IRBs)	and	Office	of	
Management	and	Budget	(OMB).	We	will	obtain	OMB	clearance	to	allow	for	the	use	of	the	risk	factor	
interview	instrument	and	the	planned	$75	participation	compensation	we	intend	to	provide	to	donors	
who	complete	the	risk	factor	interview.	Furthermore,	all	required	IRB	approvals	and	other	
administrative	approvals	will	be	obtained.	As	the	lead	institution	for	LRCC	activities,	BSRI	will	obtain	IRB	
approval	for	all	activities.	Each	blood	center	and	CTS	will	obtain	any	necessary	IRB	approvals	for	their	
respective	activities.	We	will	work	with	FDA	to	prepare	the	required	OMB	submission	documents	at	
each	stage	of	that	process.		

21	

Risk	Factor	Questionnaire	Content	
The	risk	factor	interview	covers	content	on	common	routes	of	exposure	and	also	less	common	routes	
(Appendices	8	and	9,	for	English	and	Spanish	versions).	In	addition	the	questionnaire	will	provide	each	
confirmed-positive	donor	the	opportunity	to	report	how	he/she	believes	he/she	may	have	been	
infected.	Four	versions	of	the	questionnaire	introduction	will	be	developed	in	consultation	with	the	
participating	blood	centers	to	reflect	the	required	content	for	administration	of	verbal	consent	as	
mandated	by	local	IRBs.	The	risk	factor	and	related	survey	content	is	identical	for	all	centers.	The	risk	
factor	interview	is	based	on	the	same	content	that	was	used	in	the	REDS-II	DRFS.	That	interview	was	
previously	approved	by	OMB	(OMB	Control	Number	0925-0630,	expiration	date	4/30/2014).	Content	
has	been	updated	to	reflect	changes	in	our	understanding	of	risk	factors	and	to	address	new	content	
relevant	in	the	current	time	period.	
Prospective	and	Retrospective	Interviews	
The	majority	of	risk	factor	interviews	during	TTIMS	will	be	conducted	soon	after	confirmatory	testing	is	
completed	from	donors	who	have	been	newly	classified	as	consensus	positive	for	each	infection	based	
on	blood	donation	testing	(prospective	interviews).	We	will	also	obtain	human	subjects	approvals	to	
conduct	risk	factor	interviews	of	donors	from	the	beginning	(September	25,	2015)	in	order	to	capture	
data	from	the	beginning	of	the	contract	period	(retrospective	interviews).	
Participant	Incentives	
Incentives	will	be	provided.	Donors	meeting	consensus	interview	definitions	will	receive	$75	for	
completing	the	interview.	As	for	cases,	controls	will	be	compensated	$75	for	completing	the	interview.	
Incentives	will	be	provided	through	the	same	operational	procedures	within	each	organization	that	
allow	for	personally	identifying	each	donor.	The	study	investigators	and	LRCC	staff	at	BSRI	will	not	have	
access	to	PII	and	will	not	be	responsible	for	providing	the	incentive	payments	to	participants;	each	
participating	blood	center	will	be	responsible	for	ensuring	participation	incentives	are	provided	to	
participants.	
Human	Subjects	Considerations	
All	human	subjects	and	other	approval	requirements	will	be	met	before	the	donor	interviews	can	begin.	
Confirmed-positive	donors	will	be	asked	to	complete	the	questionnaire	proximate	to	the	time	that	they	
are	notified	of	their	infection	status.	This	represents	an	emotionally	difficult	and	challenging	time	for	
donors.	Some	donors	may	be	completely	surprised	or	even	in	denial	about	at	the	results	of	testing.	The	
notification	process	is	intended	to	be	as	benign	as	possible.	The	addition	of	a	questionnaire	designed	to	
assess	risk	behaviors	into	the	notification	process	may	be	difficult	for	some	donors	to	complete.	
Participation	in	the	risk	factor	interview	is	optional	and	is	not	a	condition	for	future	counseling.	Using	
their	professional	knowledge	and	insight,	the	donor	counselors	will	decide	if	each	donor	is	in	an	
appropriate	state	of	mind	to	be	interviewed.	Donors	will	be	given	the	option	of	being	contacted	at	a	
later	time	to	complete	the	questionnaire.	Donors	may	refuse	participation	and	future	contact.		
Each	infection	has	potentially	serious	consequences	for	the	future	health	of	the	blood	donor.	Part	of	
standard	counseling	is	to	encourage	that	donors	seek	full	medical	evaluation	by	their	physician.	This	is	
22	

particularly	important	for	HIV	where	the	seriousness	of	the	infection	for	long-term	health	and	the	
potential	for	stigma	is	likely	to	bring	distress.	As	per	required	operational	procedures,	no	donor	
identifiers	that	could	reasonably	be	used	to	identify	specific	individuals	will	be	available	to	the	study	
researchers.	
	
For	false	positive	donors,	the	interview	may	also	be	useful	in	helping	donor	counselors	with	the	
counseling	message	and	in	identifying	or	ruling-out	possible	types	of	behaviors	that	could	lead	to	false	
positive	testing	results.	Again,	as	per	required	operational	procedures	no	donor	identifiers	that	could	
reasonably	be	used	to	identify	specific	individuals	will	be	available	to	the	study	researchers.	
	
A	DHHS	Certificate	of	Confidentiality	will	be	obtained	to	prevent	the	project	from	being	compelled	to	
release	any	information	reported	by	the	persons	who	participate	in	this	study,	except	under	the	special	
circumstances	as	specified	by	the	Certificate.	
	
Qualtrics™	HIPAA	and	HITECH	Compliance	
	
HIPAA	Statement:	With	some	restrictions,	Qualtrics	may	be	designated	as	a	Business	Associate	when	the	
Qualtrics	BA	Agreement	is	signed	with	a	Covered	Entity—those	organizations	that	are	required	to	
comply	with	HIPAA	privacy	rules.	All	client	data	are	considered	confidential,	and	treated	as	such,	with	no	
specific	designation	(such	as	medical	(protected	health	information,	PHI),	PII,	or	public).	Although,	there	
is	a	duty	of	care	that	Qualtrics	maintains	with	respect	to	PII	data,	for	the	LRCC	tasks,	PII	will	not	be	
captured	on	Qualtrics	servers.	
	
Related	to	HIPAA,	HITECH	(Health	Information	Technology	for	Economic	and	Clinical	Health	Act)	are	
updated	assessment	rules	to	ensure	that	data	are	properly	protected	and	best	security	practices	
followed.	By	using	secure	and	certified	data	centers,	Qualtrics	ensures	the	highest	protection	and	testing	
as	per	HITECH	requirements.	
	
If	the	Qualtrics/UCSF	partnership	dissolves	(Qualtrics	is	a	Business	Associate),	the	data	remains	on	the	
Qualtrics	servers	for	an	additional	12	months.	All	interview	data	will	be	held	in	parallel	on	servers	at	the	
LRCC	for	the	purpose	of	analysis	which	will	be	backed-up	on	regular	schedules.	At	project	completion,	
the	LRCC	will	request	data	be	purged	from	Qualtrics	servers	using	existing	request	procedures.	We	will	
request	a	final	transfer	of	data	and	deletion	from	Qualtrics	servers	at	the	end	of	the	LRCC	contract	
performance	period	as	part	of	Transition	Out	or	upon	dissolution	of	the	Qualtrics/UCSF	partnership.	
	
	

23	

Timeline	
TTIMS LRCC Protocol 1 - Risk Factors
Study Activities
Administrative
Protocol Development
Protocol Finalization
Manual of Procedures
IRB Approvals
OMB Clearance

2015
2016
2017
2018
2019
2020
S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S

Study Monitoring System (SMS)
SMS Content Development and Testing
SMS Training
Study Monitoring
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Risk Factor Survey
Survey Content Development
Survey Interviewer Training
Survey Administration
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Risk Factor Surveillance
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Manuscript Preparation and Submission

	

	

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Armstrong	GL,	Wasley	A,	Simard	EP,	McQuillan	GM,	Kuhnert	WL,	Alter	MJ.	The	prevalence	of	
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14.	
Murphy	EL,	Bryzman	SM,	Glynn	SA,	et	al.	Risk	factors	for	hepatitis	C	virus	infection	in	United	
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Alter	MJ.	Prevention	of	spread	of	hepatitis	C.	Hepatology	(Baltimore,	Md	2002;36:S93-8.	
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McQuillan	GM,	Coleman	PJ,	Kruszon-Moran	D,	Moyer	LA,	Lambert	SB,	Margolis	HS.	Prevalence	
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McAuley	JD,	Caglioti	S,	Williams	RC,	et	al.	Clinical	significance	of	nondiscriminated	reactive	
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Sharma	UK,	Stramer	SL,	Wright	DJ,	et	al.	Impact	of	changes	in	viral	marker	screening	assays.	
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Vo	MT,	Bruhn	R,	Kaidarova	Z,	Custer	B,	Murphy	EL,	Bloch	EM.	A	retrospective	analysis	of	falsepositive	infectious	screening	results	in	blood	donors.	Transfusion	2015.	
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Cleary	PD,	Singer	E,	Rogers	TF,	et	al.	Sociodemographic	and	behavioral	characteristics	of	HIV	
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Carneiro-Proietti	AB,	Catalan-Soares	BC,	Castro-Costa	CM,	et	al.	HTLV	in	the	Americas:	
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Custer	B,	Sullivan	SD,	Hazlet	TK,	Iloeje	U,	Veenstra	DL,	Kowdley	KV.	Global	epidemiology	of	
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Van	der	Bij	AK,	Coutinho	RA,	Van	der	Poel	CL.	Surveillance	of	risk	profiles	among	new	and	repeat	
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Transfusion	2006;46:1729-36.	
33.	
McMahon	JM,	Pouget	ER,	Tortu	S.	Individual	and	couple-level	risk	factors	for	hepatitis	C	
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34.	
Frew	PM,	Alhanti	B,	Vo-Green	L,	et	al.	Multilevel	factors	influencing	hepatitis	B	screening	and	
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Bowleg	L,	Neilands	TB,	Tabb	LP,	Burkholder	GJ,	Malebranche	DJ,	Tschann	JM.	Neighborhood	
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26	

Appendices	
Appendix	1	–	TTIMS	DDCC	and	LRCC	Information	Flow	Diagram	
	

	
27	

Appendix	2	–	Risk	Factor	Frequencies	Reported	by	Donors	During	the	REDS-II	Study	
	
Table	1.	Risk	Factor	Frequencies	Reported	by	Donors	During	the	REDS-II	Study:	Sexual,	behavioral	and	
other	risk	factors	for	participating	blood	donors	by	infection	status,	published	in.2	
Sexual	risk	behavior	
HIV	cases	
HBV	cases	 HCV	cases	 False-positives	
controls	
Males	
n=	149	(%)		 n=	190	(%)	 n=	186	(%)	
n=	761	(%)	
Number	of	female	sexual	
	
	
	
	
partners,	median	(IQR)	
Lifetime	
4	(1-13)	
6	(2-13)	
15	(7-30)	
5	(2-10)	
Last	5	years	
1	(0-3)	
1	(1-3)	
2	(1-3)	
1	(1-2)	
Number	of	male	sexual	
	
	
	
	
partners,	median	(IQR)	
Lifetime	
2	(0-8)	
0	(0-0)	
0	(0-0)	
0	(0-0)	
Last	5	years	
MSM	or	Sex	with	MSM,	ever	
Yes	

2	(0-5)	
	
92	(61.7)	

0	(0-0)	
	
11	(5.8)	

0	(0-0)	
	
9	(4.8)	

0	(0-0)	
	
13	(1.7)	

Monogamous,	last	12	months	
Yes	
Male	sexual	partner,	last	12	
months	
Yes	
Used	condom,	always*	
Yes	
Sexually	transmitted	disease	
Yes	
Sex	for	money	or	drugs	
Yes	
Sex	with	injecting	drug	user		
Yes	
Not	specified,	D/N*	
Sex	with	hepatitis	positive	
partner	
Yes	
Not	specified,	D/N*	
Sex	with	HIV-positive	partner	
Yes	
Not	specified,	D/N*	
Sex	with	blood	transfusion	
recipient	
Yes	
Not	specified,	D/N*	
	

	
60	(40.3)	
	

	
119	(62.6)	
	

	
136	(73.1)	
	

	
574	(75.4)	
	

78	(52.4)	
	
		21	(26.9)	
	
33	(22.3)	
	
5	(3.4)	
	
7	(4.7)	
20	(13.4)	
	

7	(3.7)		
	
2	(28.6)	
	
28	(14.7)	
	
6	(3.2)	
	
18	(9.5)	
19	(10.0)	
	

2	(1.1)	
	
0	(0.0)	
	
45	(24.2)	
	
4	(2.2)	
	
49	(26.3)	
17	(9.1)	
	

2	(0.3)	
	
	1	(50.0)	
	
53	(7.0)	
	
9	(1.2)	
	
15	(2.0)	
26	(3.4)	
	

4	(2.7)	
17	(11.4)	
	
39	(26.2)	
19	(12.8)	
	

8	(4.2)	
26	(13.7)	
	
2	(1.1)	
5	(2.6)	
	

12	(6.5)	
13	(7.0)	
	
1	(0.5)	
2	(1.1)	
	

5	(0.7)	
18	(2.4)	
	
0	(0.0)	
9	(1.2)	
	

1	(0.7)	
20	(13.4)	

4	(2.1)	
15	(7.9)	

10	(5.4)	
18	(9.7)	

26	(3.4)	
46	(6.0)	

	

28	

Appendix	2	Table	1:	Cont’d	

HIV	cases	

HBV	cases	

HCV	cases	

False-positives	
controls	
n=	825	(%)	
	

Females	
Number	of	male	sexual	
partners,	median	(IQR)	
Lifetime	
Last	5	years	
Number	of	female	sexual	
partners,	median	(IQR)	
Lifetime	
Last	5	years	
Sex	with	MSM,	ever	
Yes	
Monogamous,	last	12	months	
Yes	
Male	sexual	partner,	last	12	
months	
Yes	
Used	condom,	always†	
Yes	
Sexually	transmitted	disease	
Yes	
Sex	for	money	or	drugs	
Yes	
Sex	with	injecting	drug	user		
Yes	
Not	specified,	D/N*	
Sex	with	hepatitis	positive	
partner	
Yes	
Not	specified,	D/N*	
Sex	with	HIV-positive	partner	
Yes	
Not	specified,	D/N*	
Sex	with	blood	transfusion	
recipient	
Yes	
Not	specified,	D/N*	
	

n=	47	(%)	
	

n=	102	(%)	
	

n=	130	(%)	
	

10	(4-15)	
3	(1-5)	
	

3	(1-10)	
1	(1-2)	
	

9	(4-20)	
1	(1-2)	
	

4	(1-7)	
1	(1-1)	
	

0	(0-1)	
0	(0-0)	
	
3	(6.4)	
	
28	(59.6)	
	

0	(0-0)	
0	(0-0)	
	
3	(2.9)	
	
71	(69.6)	
	

0	(0-0)	
0	(0-0)	
	
4	(3.1)	
	
86	(66.2)	
	

0	(0-0)	
0	(0-0)	
	
11	(1.3)	
	
653	(79.2)	
	

43	(91.5)	
76	(74.5)	
	
	
6	(14.0)	 				13	(17.1)	
	
	
17	(36.2)	
13	(12.8)	
	
	
10	(21.3)	
4	(3.9)	
	
	
6	(12.8)	
10	(9.8)	
6	(12.8)	
5	(4.9)	
	
	

91	(70.0)	
	
9	(9.9)	
	
48	(36.9)	
	
12	(9.2)	
	
60	(46.2)	
9	(6.9)	
	

676	(81.9)	
	
92	(13.6)	
	
106	(12.9)	
	
0	(0.0)	
	
19	(2.3)	
32	(3.9)	
	

3	(6.4)	
3	(6.4)	
	
13	(27.7)	
5	(10.6)	
	

6	(5.9)	
11	(10.8)	
	
1	(1.0)	
1	(1.0)	
	

19	(14.6)	
8	(6.2)	
	
0	(0.0)	
1	(0.8)	
	

15	(1.8)	
21	(2.6)	
	
3	(0.4)	
13	(1.6)	
	

1	(2.1)	
3	(6.4)	

6	(5.9)	
8	(7.8)	

9	(6.9)	
12	(9.2)	

41	(5.0)	
39	(4.7)	

	
	
	

	

29	

	
Appendix	2	Table	1:	Cont’d	

HIV	cases	

HBV	cases	

HCV	cases	

False-positives	
controls	
n=	316	(%)	
n=	1,587	(%)	
	
	
	
	

Both	sexes,	lifetime	(ever)	
n=	196	(%)	 n=	292	(%)	
Other	exposures	
	
	
Injected	illegal	drugs,	steroid	
	
	
or	vitamins	
Yes	
6	(3.1)	
14	(4.8)	 116	(36.7)	
6	(0.4)	
Any	illegal	drug	use	(non	
	
	
	
injecting)	
Yes	
48	(24.5)	
59	(20.2)	 197	(62.3)	
193	(12.2)	
Tattoo	or	body	piercing‡	
	
	
	
	
Yes	
128	(65.3)	 124	(42.5)	 218	(69.0)	
671	(42.3)	
Jail,	prison,	detention,	shelter	
	
	
	
	
or	group	home	(3	nights	or	
more)	
Yes	
47	(24.0)	
54	(18.5)	 181	(57.3)	
83	(5.2)	
Blood	transfusion	
	
	
	
	
Yes	
5	(2.6)	
20	(6.9)	
57	(18.0)	
105	(6.6)	
Medical	or	dental	exposure§	
	
	
	
	
Yes	
166	(84.7)	 235	(80.5)	 308	(97.5)	
1,477	(93.1)	
HCV/HBV	infected	member	in	
	
	
	
	
the	household	
Yes	
3	(1.5)	
44	(15.1)	
37	(11.7)	
30	(1.9)	
Family/self	living	abroad	or	
	
	
	
	
immigrated		to	the	US	
Yes	
21	(10.7)	 149	(51.0)	
13	(4.1)	
88	(5.6)	
*	Not	specified,	D/N	is	included	as	a	category	when	≥10%	of	cases	or	controls	did	not	
respond	or	selected	“don’t	know”	in	response	for	this	topic		
†Always	used	condom	with	male	sexual	partners	if	had	one	or	more	male	partners	in	the	last	
12	months	
‡	Tattoo	or	body	piercing	or	3+	ear	piercings	
§	Includes	any	IM/IV	injections,	tissue	or	organ	transplant,	endoscopy,	colonoscopy,	dental	
injection,	acupuncture,	needle	stick	injury	or	body	fluid	exposure	ever	
	
	

	

30	

Appendix	3	–	TTIMS	Study	Information	Mailer	for	Cases	(English	version)	
Research	Study	Invitation		
TEMPLATE	TO	BE	MODIFIED	FOR	LOCAL	USE	[Text	in	Brackets	Requires	Local	Information]	
We	 want	 to	 invite	 you	 to	 participate	 in	 a	 research	 study	 with	 [Blood	 Systems,	 Inc].	 	 The	 study	 can	 be	
done	 in	 person	 or	 over	 the	 telephone	 and	 takes	 about	 45	 minutes	 of	 your	 time.	 The	 following	 is	 a	
description	of	the	research	study.	
If	you	choose	to	participate	and	complete	the	interview	you	will	receive	$75	for	your	time.	This	will	be	
mailed	to	your	home	address	after	you	complete	the	study.	
This	study	is	being	conducted	at	four	U.S.	blood	centers:	the	American	Red	Cross	(ARC),	Blood	Systems,	
Inc.	(BSI),	New	York	Blood	Center	(NYBC),	and	OneBlood	in	order	to	obtain	a	nationwide	understanding	
of	 risk	 factors	 for	 donating	 virus	 positive	 blood.	 The	 goal	 of	 the	 study	 is	 to	 identify	 self-reported	 risk	
factors	for	donations	that	test	positive	for	one	of	three	possible	viruses,	human	immunodeficiency	virus	
(HIV),	hepatitis	B	virus	(HBV),	and/or	hepatitis	C	virus	(HCV).	The	study	protects	your	identity	because	
the	 information	 submitted	 to	 the	 coordinating	 center	 will	 not	 include	 your	 name	 or	 other	 personally	
identifying	information.		
This	project	is	being	funded	by	the	US	Food	and	Drug	Administration	(FDA)	and	the	National	Heart	Lung	
and	Blood	Institute	of	the	National	Institutes	of	Health.	
What	will	happen	with	the	answers	I	give	during	the	interview?	
You	will	be	asked	about	known	risk	factors	for	HIV,	HBV,	and/or	HCV.	Each	virus	is	spread	in	different	
ways	 and	 you	 may	 not	 have	 had	 any	 of	 the	 risk	 factors	 that	 we	 ask	 about.	 Your	 responses	 will	 be	
grouped	 with	 other	 donors	 who	 complete	 the	 interview.	 The	 study	 will	 determine	 how	 common	
different	 risk	 factors	 are	 and	 will	 report	 summary	 measures	 on	 patterns	 of	 risk	 factors	 in	 all	 of	 the	
donors	that	tested	positive	for	the	same	virus.		
If	 you	 tell	 us	 something	 during	 the	 interview	 that	 would	 have	 made	 you	 ineligible	 to	 donate,	 we	 will	
have	 to	 add	 this	 to	 your	 donor	 record	 and	 this	 may	 lead	 to	 deferral	 from	 future	 blood	 donation.	
However,	there	will	be	no	other	repercussions	if	the	answers	you	give	now	are	different	than	those	you	
gave	when	you	donated.	
How	will	the	privacy	of	your	responses	be	protected?	
To	 help	 us	 protect	 your	 privacy,	 we	 have	 obtained	 a	 Certificate	 of	 Confidentiality	 from	 the	 US	
Department	of	Health	and	Human	Services.	
What	is	a	Certificate	of	Confidentiality?	
With	a	Certificate	of	Confidentiality,	the	researchers	cannot	be	forced	to	disclose	information	that	may	
identify	 you,	 even	 by	 a	 court	 subpoena,	 in	 any	 federal,	 state,	 or	 local	 civil,	 criminal,	 administrative,	
legislative,	 or	 other	 proceedings.	 The	 researchers	 will	 use	 the	 Certificate	 to	 resist	 any	 demands	 for	
information	that	would	identify	you,	except	as	explained	below.	
31	

The	Certificate	cannot	be	used	to	resist	a	demand	for	information	from	personnel	of	the	United	States	
Government	that	is	used	for	auditing	or	evaluation	of	federally	funded	projects.	
You	should	understand	that	a	Certificate	of	Confidentiality	does	not	prevent	you	or	a	member	of	your	
family	from	voluntarily	releasing	information	about	yourself	or	your	involvement	in	this	research.	If	an	
insurer,	employer,	or	other	person	obtains	your	written	consent	to	receive	research	information,	then	
the	researchers	may	not	use	the	Certificate	to	withhold	that	information.	
The	Certificate	of	Confidentiality	does	not	prevent	the	researchers	from	disclosing	voluntarily,	without	
your	consent,	information	that	would	identify	you	as	a	participant	in	the	research	project	under	specific	
circumstances.	For	example,	we	will	voluntarily	disclose	information	about	incidents	such	as	intent	to	
hurt	yourself	or	others.	
Who	can	answer	my	questions	about	the	study?	
Your	 participation	 in	 the	 study	 is	 voluntary	 and	 you	 may	 decide	 you	 do	 not	 want	 your	 interview	
responses	included.	If	you	have	questions	about	the	study	or	you	want	to	have	your	interview	responses	
excluded	at	any	time,	you	may	call	[Dr.	Brian	Custer	at	Blood	Systems	Research	Institute	at	(415)	9010756].	
	
If	 you	 have	 any	 questions	 about	 the	 testing	 results	 from	 your	 blood	 donation	 please	 call	 [Donor	
Counseling	 and	 Notification	 Services	 at	 (800)	 289-4923	 or	 Dr.	 Hany	 Kamel	 at	 Blood	 Systems	
headquarters	at	(480)	675-5659].	
	
If	 you	 have	 any	 questions	 about	 your	 rights	 as	 a	 research	 participant	 in	 this	 study,	 please	 call	 the	
[University	 of	 California	 San	 Francisco,	 Committee	 on	 Human	 Research,	 which	 is	 also	 known	 as	 an	
Institutional	 Review	 Board	 (a	 group	 of	 people	 who	 review	 the	 research	 to	 protect	 your	 rights)	 at	 415476-1814].	
	
	
How	do	I	join	the	study?	
Simply	call	[(800)	289-4923]	and	one	of	our	specially	trained	counselors	will	be	happy	to	enroll	you	in	
the	study.	If	we	do	not	hear	from	you	we	will	likely	give	you	a	call	to	give	you	a	chance	to	enroll.		
	
	

	

32	

Appendix	4	–	TTIMS	Study	Information	Mailer	for	Cases	(Spanish	version)		
	
To	Be	Added	
	
	

33	

Appendix	5	–	TTIMS	Study	Information	Mailer	for	Controls	(English	version)	
Research	Study	Invitation	
TEMPLATE	TO	BE	MODIFIED	FOR	LOCAL	USE	[Text	in	Brackets	Requires	Local	Information]	
We	 want	 to	 invite	 you	 to	 participate	 in	 a	 research	 study	 with	 [Blood	 Systems	 Inc.]	 	 The	 study	 can	 be	
done	 in	 person	 or	 over	 the	 telephone	 and	 takes	 less	 than	 45	 minutes	 of	 your	 time.	 The	 following	 is	 a	
description	of	the	research	study.	
If	you	choose	to	participate	and	complete	the	interview	you	will	receive	$75	for	your	time.	This	will	be	
mailed	to	your	home	address	after	you	complete	the	study.	
This	study	is	being	conducted	at	four	U.S.	blood	centers:	the	American	Red	Cross	(ARC),	Blood	Systems,	
Inc.	(BSI),	New	York	Blood	Center	(NYBC),	and	OneBlood	in	order	to	obtain	a	nationwide	understanding	
of	 risk	 factors	 for	 donating	 virus	 positive	 blood.	 The	 goal	 of	 the	 study	 is	 to	 identify	 self-reported	 risk	
factors	for	donations	that	test	positive	for	one	of	three	possible	viruses,	human	immunodeficiency	virus	
(HIV),	hepatitis	B	virus	(HBV),	and/or	hepatitis	C	virus	(HCV).	We	will	also	be	comparing	responses	from	
donors	 who	 tested	 confirmed	 positive	 to	 donors,	 like	 you,	 who	 tested	 unconfirmed	 (false	 positive)	 to	
find	 out	 if	 risk	 factors	 are	 different	 between	 these	 two	 groups	 of	 donors.	 The	 study	 protects	 your	
identity	 because	 the	 information	 submitted	 to	 the	 coordinating	 center	 will	 not	 include	 your	 name	 or	
other	personally	identifying	information.		
This	project	is	being	funded	by	the	US	Food	and	Drug	Administration	(FDA)	and	the	National	Heart	Lung	
and	Blood	Institute	of	the	National	Institutes	of	Health.	
What	will	happen	with	the	answers	I	give	during	the	interview?	
You	will	be	asked	about	known	risk	factors	for	HIV,	HBV,	and/or	HCV.	Each	virus	is	spread	in	different	
ways	 and	 you	 may	 not	 have	 had	 any	 of	 the	 risk	 factors	 that	 we	 ask	 about.	 Your	 responses	 will	 be	
grouped	 with	 other	 donors	 who	 complete	 the	 interview.	 The	 study	 will	 determine	 how	 common	
different	 risk	 factors	 are	 and	 will	 report	 summary	 measures	 on	 patterns	 of	 risk	 factors	 in	 all	 of	 the	
donors	that	tested	positive	for	the	same	virus	compared	to	donors	who	tested	false	positive.		
If	 you	 tell	 us	 something	 during	 the	 interview	 that	 would	 have	 made	 you	 ineligible	 to	 donate,	 we	 will	
have	 to	 add	 this	 to	 your	 donor	 record	 and	 this	 may	 lead	 to	 deferral	 from	 future	 blood	 donation.	
However	there	will	be	no	other	repercussions	if	the	answers	you	give	now	are	different	than	those	you	
gave	when	you	donated.	
How	will	the	privacy	of	your	responses	be	protected?	
To	 help	 us	 protect	 your	 privacy,	 we	 have	 obtained	 a	 Certificate	 of	 Confidentiality	 from	 the	 US	
Department	of	Health	and	Human	Services.	
What	is	a	Certificate	of	Confidentiality?	
With	a	Certificate	of	Confidentiality,	the	researchers	cannot	be	forced	to	disclose	information	that	may	
identify	 you,	 even	 by	 a	 court	 subpoena,	 in	 any	 federal,	 state,	 or	 local	 civil,	 criminal,	 administrative,	
legislative,	 or	 other	 proceedings.	 The	 researchers	 will	 use	 the	 Certificate	 to	 resist	 any	 demands	 for	
34	

information	that	would	identify	you,	except	as	explained	below.	
The	Certificate	cannot	be	used	to	resist	a	demand	for	information	from	personnel	of	the	United	States	
Government	that	is	used	for	auditing	or	evaluation	of	federally	funded	projects.	
You	should	understand	that	a	Certificate	of	Confidentiality	does	not	prevent	you	or	a	member	of	your	
family	from	voluntarily	releasing	information	about	yourself	or	your	involvement	in	this	research.	If	an	
insurer,	employer,	or	other	person	obtains	your	written	consent	to	receive	research	information,	then	
the	researchers	may	not	use	the	Certificate	to	withhold	that	information.	
The	Certificate	of	Confidentiality	does	not	prevent	the	researchers	from	disclosing	voluntarily,	without	
your	consent,	information	that	would	identify	you	as	a	participant	in	the	research	project	under	specific	
circumstances.	For	example,	we	will	voluntarily	disclose	information	about	incidents	such	as	an	intent	to	
hurt	yourself	or	others.	
Who	can	answer	my	questions	about	the	study?	
Your	 participation	 in	 the	 study	 is	 voluntary	 and	 you	 may	 decide	 you	 do	 not	 want	 your	 interview	
responses	included.	If	you	have	questions	about	the	study	or	you	want	to	have	your	interview	responses	
excluded	at	any	time,	you	may	call	[Dr.	Brian	Custer	at	Blood	Systems	Research	Institute	at	(415)	9010756].	
	
If	 you	 have	 any	 questions	 about	 the	 testing	 results	 from	 your	 blood	 donation	 please	 call	 [Donor	
Counseling	 and	 Notification	 Services	 at	 (800)	 289-4923	 or	 Dr.	 Hany	 Kamel	 at	 Blood	 Systems	
headquarters	at	(480)	675-5659].	
	
If	 you	 have	 any	 questions	 about	 your	 rights	 as	 a	 research	 participant	 in	 this	 study,	 please	 call	 the	
[University	 of	 California	 San	 Francisco,	 Committee	 on	 Human	 Research,	 which	 is	 also	 known	 as	 an	
Institutional	 Review	 Board	 (a	 group	 of	 people	 who	 review	 the	 research	 to	 protect	 your	 rights)	 at	 415476-1814].	
	
	
How	do	I	join	the	study?	
Simply	call	[(800)	289-4923]	and	one	of	our	specially	trained	counselors	will	be	happy	to	enroll	you	in	
the	study.		If	we	do	not	hear	from	you	we	will	likely	give	you	a	call	to	give	you	a	chance	to	enroll.		
	

	

35	

Appendix	6	–	TTIMS	Study	Information	Mailer	for	Controls	(Spanish	version)		
	
To	Be	Added	
	
	
	

36	

Appendix	7	–	Study	Management	System	Core	Content	
	
A. DONATION	DATA	
	
Donation	Identification	Number	(DIN):	_________________________	
	
Donor	Identification	Number	(Donor	ID):	_______________________	
	
Blood	Collection	Center:	__________________________	
	
Center	Code:	________	
	
Donation	Date:	Day	_____	Month	_____	Year	_____	
	
Donor	Zip	code	of	Residence:	_________________	
	
	
B. TESTING	RESULTS	
	
Please	identify	the	virus	and	the	confirmed	test	results	from	blood	donation	testing.	Please	note,	all	
HIV	positive	donors	are	eligible	for	interview.	HCV	NAT	only	or	HBV	NAT	only	confirmed-positive	
donors	are	eligible	for	interview.	Donors	eligible	for	interview	as	controls	include	those	serology	
only	false	positive	for	HIV	and/or	HBV.		
	
Confirmed	Positive:		
Virus:			 o			HIV	 	
	
Markers:			
o	Anti	HIV	-1,	-2		
	

o	HIV	NAT	

If	available:			

o	HIV-1					o	HIV	-2	

	
o			HCV		

				

				

	

o	HCV	NAT	

					

			

	

o	Anti-HBc	

Markers:				
o	Anti-HCV	
	

	
o			HBV		
Markers:					
o	HBsAg	

		o	HBV	NAT	

	
Unconfirmed	(False)	Positive:		
	
o			anti-HIV	false	positive	
o			HBsAg	false	positive	
37	

	
C. RECRUITMENT	
	
The	date	and	method	of	each	attempt	to	contact	the	donor	and	the	results	of	that	attempt	will	be	
recorded	using	this	form.	
	
	
D. PLASMA	UNIT	TRACKING	
	
The	status	of	plasma	unit,	retention	tube,	and	testing	lab	residual	sample	retrieval	will	be	
documented	using	this	form.	Entries	include	whether	retrieval	was	necessary,	successful,	and	date	
shipped	to	CTS	or	LRCC.		
	
E. SPECIAL	SAMPLE	COLLECTION	AND	TRACKING	
	
If	there	is	a	need	for	additional	sample	collection,	the	status	(successful/date	shipped	to	CTS	or	
LRCC)	will	be	tracked	using	this	form.			
	
	
	

38	

Appendix	8	–	TTIMS	Risk	Factor	Questionnaire	(English	version)		
	
OMB	Control	Number:	XXXX-XXXX	
OMB	Clearance	Expiration	Date:	MM-DD-YYYY	
	
SECTION	A	-	DONATION	DATA	AND	VERBAL	CONSENT	
	
Notes	to	interviewer:		
1. Administer	this	survey	as	early	as	possible	after	the	date	that	disease	and	marker	testing,	
including	confirmation	testing,	is	completed	for	the	donation.	
2. Review	the	infection	marker	testing	results	before	contacting	the	donor.	
3. Complete	the	Donation	Data	section	before	contacting	the	donor.	
4. Be	sure	to	properly	identify	the	donor	according	to	standard	operational	procedures	
5. When	reading	the	possible	answers	to	the	donor,	do	not	say	“	Don’t	know”	or	“Refuse	to	
answer”		
DONATION	DATA	
	
Donation	Identification	Number	(DIN):	_________________________	
Donor	Identification	Number	(Donor	ID):	_______________________	
Blood	Collection	Center:	__________________________	
Center	Code:	________	
Donation	Date:	Day	_____	Month	_____	Year	_____	
Donor	Type	(select	one):	¡		Case					¡		Control	
Date	of	Interview:		Day____		Month	_____	Year	____	
Interviewer	Initials:	______________	

	 	

	

Interview	Language	(select	one):	¡		English					¡		Spanish	
	
VERBAL	CONSENT	–	PLEASE	READ	THE	FOLLOWING	TO	THE	DONOR:	
	
I	am	asking	you	to	be	part	of	a	research	study	about	risk	factors	for	infectious	diseases	in	blood	donors.		
The	study	is	being	done	by	[Your	Organization],	other	blood	centers,	the	US	Food	and	Drug	
Administration,	and	the	National	Institutes	of	Health,	National	Heart	Lung	and	Blood	Institute.	
FOR	CONFIRMED	POSITIVES:	I	am	contacting	you	because	testing	on	your	donation	confirmed-positive	
for	a	viral	infection	the	last	time	you	donated	blood.		If	you	agree	to	participate,	I	will	ask	you	questions	
about	possible	ways	you	could	have	gotten	infected.	
FOR	FALSE	POSITIVES:	I	am	contacting	you	because	your	recent	donation	tested	unconfirmed	or	false	
positive.		If	you	agree	to	participate,	I	will	ask	you	questions	about	risk	factors	for	viral	infections	so	we	
can	compare	answers	from	false	positive	donors,	like	you,	to	answers	that	true	positive	donors	give	on	
the	same	questions.	
39	

The	interview	should	take	no	more	than	45	minutes.	Your	participation	is	voluntary	and	you	may	refuse	to	
answer	any	question.	Some	of	the	questions	are	about	private	matters	such	as	sexual	experiences	and	
drug	use.	Our	purpose	in	asking	these	questions	is	to	improve	the	safety	of	donated	blood.	If	you	tell	us	
something	during	the	interview	that	would	have	made	you	ineligible	to	donate,	I	will	have	to	add	
this	to	your	donor	record	and	this	may	lead	to	deferral	from	future	blood	donation.	However,	there	
will	be	no	consequences	if	the	answers	you	give	now	are	different	than	those	you	gave	when	you	
donated	blood.	
We	will	keep	your	responses	confidential.		To	help	us	protect	your	privacy,	we	have	obtained	a	
Certificate	of	Confidentiality	from	the	US	Department	of	Health	and	Human	Services.		With	this	
Certificate,	the	researchers	cannot	be	forced	to	disclose	information	that	may	identify	you.		The	risk	
of	participating	in	this	study	is	if	the	information	you	give	is	not	kept	confidential.		However	no	
information	that	identifies	you	by	name	will	be	entered	into	the	database,	only	the	answers	to	these	
questions.	There	is	no	direct	benefit	to	you	of	participation	other	than	the	knowledge	that	you	are	
helping	efforts	to	maintain	a	safe	blood	supply	by	allowing	us	to	understand	risks	and	motivations	of	
blood	donors.		
If	you	have	any	questions,	feel	free	to	ask	me	now.		You	may	also	call	XXX-XXXX.		Do	you	have	any	
questions	before	we	begin?	
	
Do	you	agree	to	participate	in	this	study?			
¡ Yes	(If	YES,	verbal	consent	obtained)	
¡ No			
	
[For	printed	record	maintained	at	blood	center]	
	
Signature	of	Interviewer:		
	
____________________________________			Date:	__________________	

	

40	

SECTION	B	–	DONOR	DEMOGRAPHIC	DATA	
	
(Please	read	the	following:)		First,	I	will	ask	you	some	questions	about	you	and	about	blood	
donation.		I	remind	you	that	your	answers	will	be	kept	confidential.		
	
1. What	sex	do	you	consider	yourself	to	be?	
¡ Male					
¡ Female					
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
2. What	sex	were	you	assigned	at	birth?					
¡ Male	
¡ Female					
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
3. What	is	your	birth	date?		
Day	____		Month	____	Year	____		
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
4. What	is	your	country	of	birth?		
¡ USA	
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
5. At	the	time	of	your	last	blood	donation,	what	was	the	highest	level	of	education	you	
had	completed?		
¡ Never	been	to	school	
¡ Elementary	school	
¡ Junior	high	school	or	middle	school	
¡ High	school	
¡ College	or	technical	school	
¡ Graduate	school	or	professional	degree	
¡ (Don’t	know)	
¡ (Refuse	to	answer)		
	
6. Are	you	of	Hispanic,	Latino,	or	Spanish	origin?		
¡	Yes	
41	

¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
		
7. What	is	your	race?	(Please	read	the	following:)	Federal	policy	defines	“Hispanic”	not	as	
a	race,	but	as	an	ethnicity.	Hispanics	can	be	of	any	race.	[MARK	ALL	THAT	APPLY]	
¡ White	
¡ Black	or	African	American	
¡ Asian	
¡ American	Indian	or	Alaska	Native	
¡ Native	Hawaiian	or	other	Pacific	Islander	
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
8. At	the	time	of	your	last	blood	donation,	what	was	your	occupation?	[Interviewer,	
please	ask	as	an	open-ended	question,	then	select	the	most	applicable	option	below]	
¡ Agriculture,	Forestry,	Fishing,	Hunting,	Mining,	Quarrying,	Oil	and	Gas	Extraction	
¡ Construction	and	Manufacturing	
¡ Wholesale	and	Retail	Trade	
¡ Transportation,	Warehousing,	and	Utilities		
¡ Information	Services	(e.g.	tv,	film,	radio,	news,	library,	publishing)	
¡ Finance,	Insurance,	Real	Estate,	Rental,	Leasing	
¡ Professional,	Scientific,	and	Technical	Services	
¡ Management	and	Administrative	Support	
¡ Educational	Service	
¡ Healthcare	and	Social	Assistance	
¡ Arts,	Entertainment,	and	Recreation	
¡ Accommodation	and	Food	Services	
¡ Public	Administration	(i.e.	Government)	
¡ Military	
¡ Retired	
¡ Disabled	
¡ Unemployed	
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
9. At	the	time	of	your	last	donation,	what	was	your	annual	household	income	from	all	
sources?	[Interview,	please	read	all	numerical	answer	choices]	
¡ Less	than	$10,000	
¡ $10,000	to	less	than	$30,000	
42	

¡
¡
¡
¡
¡
¡

$30,000	to	less	than	$50,000	
$50,000	to	less	than	$75,000	
$75,000	to	less	than	$100,000	
$100,000	or	more	
(Don’t	know)	
(Refuse	to	answer)	

	
10.
¡
¡
¡
¡
¡
¡
¡

At	the	time	of	your	last	donation,	what	was	your	marital	status?	
Single,	never	married	SKIP	TO	QUESTION	12	
Living	together,	but	not	legally	married	
Married	
Separated	or	divorced								
Widowed	 SKIP	TO	QUESTION	12	
(Don’t	Know)	SKIP	TO	QUESTION	12	
(Refuse	to	answer)	SKIP	TO	QUESTION	12	
	
11. At	the	time	of	your	last	donation	if	you	were	married	or	living	with	a	partner,	what	was	
the	gender	of	this	person?	
¡			Male	
¡ Female	
¡ Other	(SPECIFY)	____________________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
12.
¡
¡
¡
¡
¡
¡

Which	of	the	following	best	represents	how	you	think	of	yourself?	
Straight/heterosexual	
Bisexual	
Gay/lesbian/homosexual	
Something	else	
(Don't	know)	
(Refuse	to	answer)	

	
13. Have	you	ever	been	vaccinated	against	hepatitis	B	virus?		
¡ Yes	
13.1	Were	you	vaccinated	as	an….?	
¡	Infant	
¡	Child	
¡	Adult	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
43	

14. Before	your	last	donation	did	you	ever	take	PRE-exposure	prophylaxis,	or	PrEP?	
[Interviewer,	please	read	the	following:]	PrEP	is	antiviral	medication	taken	daily	for	
months	or	years	to	reduce	a	person’s	chance	of	getting	HIV.			
¡	Yes	
¡	No	 SKIP	TO	QUESTION	16	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
15. In	the	month	before	your	last	blood	donation,	were	you	taking	PRE-exposure	
prophylaxis,	or	PrEP?		
¡	Yes	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
16. Before	your	last	donation	did	you	ever	take	POST-exposure	prophylaxis,	or	PEP?	
[Interviewer,	please	read	the	following:]	PEP	is	antiviral	medication	taken	daily	for	28	
days	after	a	person’	has	had	a	single	high-risk	exposure	to	HIV.			
¡	Yes	
¡	No	 SKIP	TO	QUESTION	18	for	HIV	positive	donors,	otherwise	skip	to	Question	19	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
17. In	the	month	before	your	last	blood	donation,	were	you	taking	POST-exposure	
prophylaxis,	or	PEP?		
¡	Yes	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
18. [For	HIV	confirmed-positive	donors	only]	Did	you	know	you	were	infected	with	HIV	
before	you	donated	blood?		
¡	Yes	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
19. Before	your	last	donation,	did	you	ever	take	anti-retroviral	therapy	for	HIV	infection?		
¡	Yes	
¡	No	 SKIP	TO	QUESTION	21		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
20. In	the	month	before	your	blood	donation,	were	you	taking	anti-retroviral	therapy	for	
HIV	infection?	
¡	Yes	
44	

¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
21. Before	your	last	blood	donation,	did	you	do	any	activities	that	you	think	may	have	put	
you	at	risk	for	an	HIV	infection	or	hepatitis	infection?		
¡	Yes	
21.1	What	was	the	activity	or	activities?	[Interviewer,	please	ask	as	an	open-ended	
question,	then	select	the	most	applicable	option(s)	below:]	
¡	Heterosexual	contact	
¡	Homosexual	contact	
¡	Unsafe	sexual	contact	(did	not	use	condoms	or	other	protective	barriers)	
¡	Sexual	contact,	not	specified	
¡	IDU	
¡	Medical/Dental	procedure	
¡	Accidental	needle	stick	
¡	Tattoo/Piercing	
¡	Blood	transfusion	
¡	From	mother	at	birth	
¡	Non-sexual	contact	(work/family	exposure)	
¡	Travel	or	living	in	a	foreign	country	
¡	Other	(SPECIFY)________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
22. Can	you	specify	the	date	when	you	think	you	might	have	got	infected?		
¡ Yes	
22.1	 Month_____	Year	______		
¡ No	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
23. At	the	time	of	your	last	donation	were	you	aware	that	the	activity	you	thought	might	
be	the	reason	for	your	infection	could	place	you	at	a	higher	risk	for	infection?		
¡	Yes	
23.1	How	did	you	find	out	the	activity	could	place	you	at	higher	risk	for	infection?	
[Interviewer,	please	ask	as	an	open-ended	question,	then	select	the	most	
applicable	option	below:]	
¡	Healthcare	provider	
¡	Blood	center	
¡	Internet	
¡	Friends	
¡	Other	(SPECIFY)________________	
45	

¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
24. Before	your	most	recent	donation	had	you	previously	donated	at	this	or	any	other	
blood	or	plasma	center	or	blood	drive?	[IF	YES,	MARK	ALL	THAT	APPLY]	
¡ Yes	
24.1	Where	did	you	donate?	
¡	This	blood	center	
¡	Another	blood	center	
¡	At	a	plasma	center	where	I	was	paid	for	donating	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
25. Please	tell	me	whether	any	of	the	following	reasons	or	factors	contributed	to	your	
decision	to	donate	blood.	For	each	statement,	please	answer	yes	or	no.		
[READ	SLOWLY	AND	MARK	AN	ANSWER	FOR	EACH]	
	
a. I	wanted	to	donate	blood	to	help	someone	in	need	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
		
b. In	response	to	a	TV	or	radio	campaign,	a	phone	call,	or	letter	from	blood	bank	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
c. I	was	encouraged	or	pressured	by	family,	friends,	coworkers,	or	by	someone	at	a	blood	
drive	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
d. I	wanted	to	get	my	test	results	for	my	blood	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
e. I	wanted	to	get	the	incentives	for	donating	that	the	blood	bank	was	offering	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
f. I	donated	to	help	others	after	a	natural	or	man-made	disaster	or	tragedy	occurred	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
26. Is	there	any	other	reason	why	you	came	to	the	blood	center?	
¡	Yes	(SPECIFY)	____________________________________	
¡	No		
¡	(Don’t	know)	
46	

¡	(Refuse	to	answer)	
	

	

27. Did	any	of	the	following	factors	influence	your	decision	to	come	to	the	blood	center?	
For	each	statement,	please	answer	yes	or	no.			
[READ	SLOWLY	AND	MARK	AN	ANSWER	FOR	EACH]	
	
a. Blood	center	testing	is	confidential	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
b. Blood	center	testing	is	more	accurate	than	at	other	test	sites	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
c. Blood	center	testing	is	free	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
d. I	think	that	the	tests	would	identify	any	problem	with	my	blood	
¡	Yes		¡	No		¡	(Don’t	know)		¡	(Refuse	to	answer)	
	
28. Outside	of	blood	donation,	have	you	previously	been	tested	for	HIV?		
¡ Yes	
28.1	When	was	the	last	time	you	were	tested	for	HIV?	
Month_____	Year	______	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
28.2	What	was	the	result	of	the	test?		
¡			Positive	
¡			Negative	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡ No	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
29. Outside	of	blood	donation,	have	you	previously	been	tested	for	HBV?	
¡ Yes	
29.1	When	was	the	last	time	you	were	tested	for	HBV?	
Month_____	Year	______	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
29.2	What	was	the	result	of	the	test?		
¡			Positive	
¡			Negative	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
47	

¡ No	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
30. Outside	of	blood	donation,	have	you	previously	been	tested	for	HCV?	
¡ Yes	
30.1	When	was	the	last	time	you	were	tested	for	HCV?	
Month_____	Year	______	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
	30.2	What	was	the	result	of	the	test?		
¡			Positive	
¡			Negative	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡ No	
¡ (Don’t	know)	
¡ (Refuse	to	answer)
	
	

48	

SECTION	C	–	RISK	FACTORS	ASSESSMENT	–	PART	I	
	
(Please	read	the	following:)		In	this	next	section,	I	will	ask	you	some	questions	about	
behaviors	you	may	or	may	not	have	engaged	in	that	can	increase	the	risk	of	infection.		Some	
people	may	have	had	many	different	experiences	while	others	have	not.		I	am	asking	you	for	
this	information	because	the	data	could	help	improve	the	safety	of	the	blood	supply.	I	
remind	you	that	your	answers	will	be	kept	confidential.	
	
For	the	next	few	questions	unless	stated	otherwise	the	term	“sex”	refer	to	any	of	the	
following	activities,	whether	or	not	a	condom	or	other	protection	was	used:	
1. Vaginal	Sex	(contact	between	penis	and	vagina)		
2. Oral	Sex	(mouth	or	tongue	on	someone’s	vagina,	penis,	or	anus)	
3. Anal	Sex	(contact	between	penis	and	anus)		
	
31. Using	these	definitions	of	sex,	in	the	12	months	before	your	last	donation	did	you	have	
sex?	
¡	Yes	
¡	No	 SKIP	TO	QUESTION	34	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
32. In	the	12	months	before	your	last	donation	did	you	have	sex	with	only	one	partner?		
¡	Yes		
¡	No		 SKIP	TO	QUESTION	34	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
33. To	the	best	of	your	knowledge,	in	the	12	months	before	your	last	donation	did	your	
partner	have	sex	with	only	you?	
¡	Yes	
¡	No		
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
Now	I	am	going	to	ask	you	about	sexual	partners	and	sexual	contacts	you	have	had	over	
different	time	periods	in	your	life.		
	
34. How	many	male	sexual	partners	have	you	had	in	your	lifetime?		Please	include	both	
ongoing	partners	and	one-time	encounters	with	men.	
_________		IF	NONE,	SKIP	TO	QUESTION	39		
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
35. In	the	5	years	before	your	last	blood	donation,	how	many	male	sexual	partners	did	you	
have?	Please	include	both	ongoing	partners	and	one-time	encounters	with	men.	
_________	
49	

¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
36. In	the	12	months	before	your	last	blood	donation,	how	many	male	sexual	partners	did	
you	have?	Please	include	both	ongoing	partners	and	one-time	encounters	with	men.	
_________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
37. For	this	question	do	not	include	oral	sex.	Regarding	your	male	sexual	partners	and	onetime	encounters	with	men	in	the	12	months	before	your	last	blood	donation	if	you	had	
vaginal	or	anal	sex	how	often	did	you	use	condoms	or	protective	barriers?		
¡ Never	
¡ Sometimes	
¡ Always	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
38. Before	your	most	recent	blood	donation,	when	was	your	last	sexual	contact	with	a	
male?		
Month	__________		Year	__________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
39. How	many	female	sexual	partners	have	you	had	in	your	lifetime?		Please	include	both	
ongoing	partners	and	one-time	encounters	with	women.	
_________	IF	NONE,	SKIP	TO	QUESTION	44	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
40. In	the	5	years	before	your	last	blood	donation,	how	many	female	sexual	partners	did	
you	have?	Please	include	both	ongoing	partners	and	one-time	encounters	with	women.	
_________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
41. In	the	12	months	before	your	last	blood	donation,	how	many	female	sexual	partners	
did	you	have?	Please	include	both	ongoing	partners	and	one-time	encounters	with	
women.	
_________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
50	

	
	
42. For	this	question	do	not	include	oral	sex.	Regarding	your	female	sexual	partners	and	
one-time	encounters	with	women	in	the	12	months	before	your	last	blood	donation	if	
you	had	vaginal	or	anal	sex	how	often	did	you	use	condoms	or	protective	barriers?	
¡ Never	
¡ Sometimes	
¡ Always	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
43. Before	your	most	recent	blood	donation,	when	was	your	last	sexual	contact	with	a	
female?	
Month	__________		Year	__________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
44. Before	your	last	donation,	did	you	ever	have	a	sexually	transmitted	disease,	also	known	
as	a	STD?	Examples	of	STDs	include	gonorrhea,	chlamydia,	syphilis,	genital	herpes,	
genital	warts,	and	HPV.		
¡ Yes	
44.1	Can	you	tell	me	which	STD?	
¡	Gonorrhea	
¡	Chlamydia	
¡	Syphilis	
¡	HPV	
¡	Genital	herpes	
¡	Genital	warts	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
¡	No	SKIP	TO	QUESTION	46	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
45. In	the	12	months	before	your	last	blood	donation,	did	you	have	a	STD?	Examples	of	
STDs	include	gonorrhea,	chlamydia,	syphilis,	genital	herpes,	genital	warts,	and	HPV.		
¡ Yes	
45.1	Can	you	tell	me	which	STD?	
¡	Gonorrhea	
¡	Chlamydia	
¡	Syphilis	
¡	HPV	
¡	Genital	herpes	
¡	Genital	warts	
51	

¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	

	

¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
46. 	Before	your	last	donation,	did	you	ever	inject	drugs,	steroids,	or	vitamins	not	
prescribed	by	a	health	care	provider?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	50	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
47. In	the	12	months	before	your	last	blood	donation,	did	you	inject	drugs,	steroids,	or	
vitamins	not	prescribed	by	a	health	care	provider?	
¡ Yes	
47.1	Can	you	tell	me	what	substance	was	or	substances	were	injected?	[MARK	ALL	
THAT	APPLY]	
¡	Heroine	
¡	Cocaine	
¡	Methamphetamine	
¡	Other	(SPECIFY)____________	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
48. Before	your	last	donation,	did	you	ever	share	needles	or	syringes	with	another	person?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	50	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	

	
49. In	the	12	months	before	your	last	blood	donation,	did	you	share	needles	or	syringes	
with	another	person?			
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
50. Before	your	last	donation,	did	you	ever	use	any	drugs	that	you	did	not	inject,	that	is,	
drugs	that	are	smoked,	snorted,	inhaled,	or	taken	orally?	Please	do	not	include	the	use	
of	marijuana	when	answering	this	question.		
¡	Yes	
¡	No	SKIP	TO	QUESTION	52	
52	

¡	(Don’t	know)	
¡	(Refuse	to	answer)	
		
51. In	the	12	months	before	your	last	blood	donation,	did	you	use	any	drugs	that	you	did	
not	inject,	that	is,	drugs	that	are	smoked,	snorted,	inhaled,	or	taken	orally?	Please	do	
not	include	the	use	of	marijuana	when	answering	this	question.		
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
52. Before	your	last	donation	did	you	ever	intentionally	engage	in	sex	while	“high”	or	
“drunk”?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	54	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
53. In	the	12	months	before	your	last	blood	donation,	did	you	intentionally	engage	in	sex	
while	“high”	or	“drunk”?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
54. Have	you	ever	given	or	received	money	or	drugs	for	sex?	
¡	Yes	
¡	No	SKIP	TO	QUESTION	56	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
55. In	the	12	months	before	your	last	blood	donation,	did	you	give	or	receive	money	or	
drugs	for	sex?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
	
	

	

53	

SECTION	C	–	RISK	FACTORS	ASSESSMENT	PART	II	
	
(Please	read	the	following:)	Now	I	am	going	to	ask	you	about	other	risk	factors	or	
behaviors	that	can	increase	the	chances	of	infection.		Please	answer	each	question	to	the	
best	of	your	knowledge.		I	am	asking	you	for	this	information	because	it	could	help	to	
improve	the	safety	of	the	blood	supply.		I	remind	you	that	your	answers	will	be	confidential.	
	
56. How	many	tattoos	do	you	have	on	your	body?	(When	answering	this	question	please	
include	permanent	cosmetics	(lip,	brow	or	eyeliner),	which	are	applied	in	a	similar	way	
as	tattoos).		
¡ 0	(No	tattoos)		SKIP	TO	QUESTION	59	
¡ 1	
¡ 2	
¡ 3	or	more	
¡ (Don’t	know)	
¡ (Refuse	to	answer)		
	
57. In	the	12	months	before	your	last	blood	donation,	did	you	get	a	new	tattoo	or	had	one	reapplied?	(Again,	when	answering	this	question	please	include	permanent	cosmetics	(lip,	
brow	or	eyeliner),	which	are	applied	in	a	similar	way	as	tattoos)	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
58. Where	did	you	go	to	have	your	most	recent	tattoo(s)	applied?		
¡ Tattoo	parlor	
¡ Beauty	salon		
¡ At	home	or	a	friend’s	house	
¡ At	a	party	or	rave	
¡ In	jail,	prison	or	a	detention	center	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
59.
¡
¡
¡
¡
¡
¡

In	total,	how	many	ear	piercings	do	you	have?		
0	(No	piercings)		SKIP	TO	QUESTION	61	
1	
2	
3	or	more	
(Don’t	know)	
(Refuse	to	answer)		
	
60. In	the	12	months	before	your	last	blood	donation,	did	you	get	any	new	ear	piercings?			
¡	Yes	
54	

¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
61. In	total,	how	many	body	piercings	do	you	have?	
¡ 0	(No	piercings)		SKIP	TO	QUESTION	63	
¡ 1	
¡ 2	
¡ 3	or	more	
¡ (Don’t	know)	
¡ (Refuse	to	answer)		
	
62. In	the	12	months	before	your	last	blood	donation,	did	you	get	any	new	body	piercings?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
63. Have	you	ever	spent	three	or	more	nights	in	a	row	in	any	of	the	following?	(MARK	ALL	
THAT	APPLY)		
¡ Jail	or	Prison	
¡ Detention	Center	(For	example,	juvenile	detention	or	inpatient	treatment)	
¡ A	Shelter	or	Group	Home	
¡ None	of	the	above	SKIP	TO	QUESTION	66	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	

	

64. In	the	12	months	before	your	last	blood	donation,	did	you	spend	three	or	more	nights	
in	a	row	in	jail,	prison,	a	detention	center,	a	shelter,	or	a	group	home?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
		
	
65. In	total,	how	long	did	you	spend	in	jail,	prison,	a	detention	center,	a	shelter,	or	a	group	
home?	
¡ Less	than	1	month	
¡ 1	month	to	less	than	6	months	
¡ 6	months	or	more	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
	

55	

SECTION	C	RISK	FACTOR	ASSESSMENT	PART	III	–	Sexual	Partner	Exposures	
	
[Please	read	the	following:]	These	next	questions	ask	about	the	health	and	risk	factors	of	
your	current	and	previous	sexual	partners.	While	you	may	not	know	their	exact	medical	
histories,	please	answer	these	questions	to	the	best	of	your	ability.		
	
I	will	now	remind	you	of	the	definition	of	sex	for	the	purposes	of	this	questionnaire.	The	
terms	“sexual	contact”	and	“sex”	refer	to	any	of	the	following	activities,	whether	or	not	a	
condom	or	other	protection	was	used:	
1. Vaginal	Sex	(contact	between	penis	and	vagina)		
2. Oral	Sex	(mouth	or	tongue	on	someone’s	vagina,	penis,	or	anus)	
3. Anal	Sex	(contact	between	penis	and	anus)		
	
66. Have	you	ever	had	sex	with	anyone	who	has	injected	drugs,	steroids	or	vitamins	not	
prescribed	by	a	health	care	provider?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	68	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
67. In	the	12	months	before	your	last	blood	donation,	did	you	have	sex	with	anyone	who	
has	injected	drugs,	steroids	or	vitamins	not	prescribed	by	a	health	care	provider?		
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
68. Have	you	ever	had	sex	with	a	male	who	has	had	sex	with	another	male?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	70	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
69. In	the	12	months	before	your	last	blood	donation,	did	you	have	sex	with	a	male	who	
has	had	sex	with	another	male?	
¡		Yes	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
70. Have	you	ever	had	sex	with	anyone	who	has	tested	positive	for	hepatitis?		
¡		Yes	
¡		No	SKIP	TO	QUESTION	72	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
56	

71. In	the	12	months	before	your	last	blood	donation,	did	you	have	sex	with	anyone	who
has	tested	positive	for	hepatitis?
¡		Yes	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
72. Before	your	last	donation,	did	you	ever	have	sex	with	anyone	who	has	tested	positive
for	HIV?
¡		Yes	
¡		No	SKIP	TO	QUESTION	74	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
73. In	the	12	months	before	your	last	blood	donation,	did	you	have	sex	with	anyone	who
has	tested	positive	for	HIV?
¡		Yes	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
74. Have	you	ever	had	sex	with	anyone	who	has	received	a	blood	transfusion?
¡		Yes	
¡		No	SKIP	TO	QUESTION	76	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
75. In	the	12	months	before	your	last	blood	donation,	did	you	have	sex	with	anyone	who
has	received	a	blood	transfusion?
¡		Yes	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	

57	

SECTION	C	RISK	FACTOR	ASSESSMENT	PART	IV	–	Medical	and	Other	Exposures	
	
[Please	read	the	following:]	This	next	set	of	questions	asks	about	medical	procedures	you	
may	have	undergone	or	accidents	you	may	have	experienced.	I	once	again	remind	you	that	
your	answers	are	confidential.	
	
	
76. Have	you	ever	received	a	blood	transfusion?		
¡		Yes	
76.1	When	was	the	last	time	you	had	a	blood	transfusion?	
Month_____	Year	_____	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
77. Have	you	ever	received	an	organ	or	tissue	transplant?	Examples	of	tissues	that	are	
commonly	transplanted	include	bone,	skin,	corneas,	heart	valves,	stem	cells.	
¡		Yes			
	
77.1	What	type	of	organ	or	tissue?	
(SPECIFY)	____________________________	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
	
77.2	When	was	the	last	time	you	received	a	tissue	or	organ	transplant?	
Month	_____		Year	_____	
¡ (Don’t	know)	
¡ (Refuse	to	answer)	
¡		No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
78. Have	you	ever	received	acupuncture?	
¡		Yes	
¡		No	SKIP	TO	QUESTION	80	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
79. In	the	12	months	before	your	last	blood	donation,	did	you	receive	acupuncture?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
58	

80. Have	you	ever	had	a	needle	stick	injury	(accidentally	been	stuck	by	a	needle	or	other	
sharp	instrument	after	it	was	used	for	providing	medical	care	to	someone	else)	or	some	
other	unintentional	needle	stick?		
¡	Yes	
¡	No	SKIP	TO	QUESTION	82	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
81. In	the	12	months	before	your	last	blood	donation,	did	you	have	a	needle	stick	injury?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
82. Did	you	ever	get	someone	else’s	blood,	body	fluids,	vomit,	or	feces	splashed	into	your	
eyes,	mouth,	or	in	an	open	skin	wound?	
¡	Yes	
¡	No	SKIP	TO	QUESTION	84	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
83. In	the	12	months	before	your	last	blood	donation,	did	you	get	someone	else’s	blood,	
body	fluids,	vomit,	or	feces	splashed	into	your	eyes,	mouth,	or	in	an	open	skin	wound?	
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
84. To	the	best	of	your	knowledge,	before	your	last	donation	was	anyone	living	in	your	
household	(including	family,	friends	or	roommates)	infected	with	HIV,	hepatitis	B	or	
hepatitis	C?	
¡	Yes	
84.1	Can	you	tell	me	which	person(s)	is/are/were	infected?	
[MARK	ALL	THAT	APPLY]		
¡			Mother	
¡ Father	
¡ Sister	or	brother	
¡ Spouse	or	partner		
¡ Child	
¡ Another	relative	
¡ Roommate	
¡ Friend	
¡ (Don’t	know)	
¡ (Refuse	to	answer)		
59	

¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
85. Are	you	currently	taking	antiviral	therapy?		
¡	Yes	
¡	No	
¡	(Don’t	know)	
¡	(Refuse	to	answer)	
	
	
END	OF	QUESTIONNAIRE	
	
[Please	Read]	Thank	you	for	taking	the	time	to	complete	this	questionnaire.		If	you	have	any	
questions	or	concerns,	you	may	ask	me	now.		You	can	also	contact	Donor	Counseling	and	
Notification	Services	for	more	information	at	(XXX)	XXX-XXXX.	
	
[Interviewer	Comments:	Please	provide	any	additional	comments	or	impressions	about	the	risk	
factors	disclosed	or	not	disclosed	by	the	donor]	
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________	

60	

Appendix	9	–	TTIMS	Risk	Factor	Questionnaire	(Spanish	version)	
	
To	Be	Added	
	

61	


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