Summary of Changes NHSS 2015

National HIV Surveillance System (NHSS)
Attachment 11.

Summary of Proposed Changes in the ICR for the
National HIV Surveillance System (NHSS) OMB # 0920-0573

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Summary of Proposed Changes in the ICR for the
National HIV Surveillance System (NHSS) OMB #
0920-0573 Attachment 11

Summary of Revisions
The revisions to this ICR include the addition of annual
reporting hours for completing a Standards Evaluation Report (SER)
and an Annual Performance Report (APR). Modifications to currently
collected data elements and forms including the Adult Case Report
Form (ACRF), Pediatric Case Report Form (PCRF) and the Perinatal HIV
Exposure Reporting (PHER) form are also requested.
CDC monitors data quality and implementation of HIV
surveillance programs and health departments report on their
progress twice a year using process and outcome standards. Findings
from these reports are used to improve data quality, interpretation,
usefulness, and efficiency, as well as to monitor performance and
progress in achieving both state and national HIV surveillance
program objectives. The SER consists of a brief set of questions
specific to data evaluation standards and laboratory reporting that
minimizes the reporting burden on health departments. CDC provides
standard SAS programs that can be run on state and local
surveillance databases to extract the needed evaluation data in the
report. Laboratory reporting questions are used to characterize the
completeness and quality of data reported from laboratories in each
jurisdiction. The information collected on laboratory data and data
quality measures are used to ensure the accuracy, timeliness, and
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completeness of the national HIV surveillance data which are widely
used and disseminated and critical for monitoring and evaluating the
objectives of the National HIV/AIDS Strategy (NHAS). In addition,
health departments annually provide a narrative report describing
their progress towards achieving program objectives including an
implementation plan and timeline as part of the APR. The project
narratives, implementation plans and timelines of the APR are
critical for ensuring funded programs are making adequate progress
toward meeting program objectives outlined in the cooperative
agreement for the NHSS. See attachments 3(e) and 3(f) for
information collected for the SER and the APR.
Form revisions requested in this ICR will generally enhance
efficiency of data collection and not increase the burden of current
data collection. Form revisions include necessary changes related to
advances in testing technologies (e.g., categories to accommodate
new tests and testing algorithms) and advances in antiretroviral
(ARV) treatments(e.g. differentiating reasons for treatment such as
pre-exposure prophylaxis) and other non-substantial editorial
changes aimed to improve format and usability of the ACRF, PCRF, and
PHER forms (e.g., standardization of date variables). The specific
changes to the ACRF, PCRF, and PHER form are summarized below and
described in Table 1 at the end of this document.

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Summary of Revisions to the ACRF and PCRF
New categories of diagnostic tests have become available. The
first category can detect and distinguish between HIV-1 antigen and
HIV-1/2 antibody. The second category can detect and distinguish
among HIV-1 antigen, HIV-1 antibody, and HIV-2 antibody. However,
the current versions of the ACRF and PCRF do not include the new
categories of tests or result options that are necessary to
accurately capture the results of these tests. Also, some test
categories on the current ACRF and PCRF refer to “typedifferentiating tests”, but the newly available tests can
distinguish between antigen and antibody, which are analytes, not
“types” (HIV-1 vs. HIV-2). The ACRF and PCRF have been updated to
include the new tests and result options.
The Patient Identification and Residence at Diagnosis sections
of the ACRF and PCRF have been updated to add the address date
associated with the current street address and the residence at
diagnosis street address. “Address Date” has been added after
“Current Address, Street” in the Patient Identification section. The
phone, city, county, state/country and zip code has been shifted to
account for the addition of the address date and “Address Date” has
been added after “Street Address” in the Residence at Diagnosis
section. Health departments need this information to accurately
capture the date associated with the patient’s current address and
address at diagnosis in the NHSS. Assessment of the most recent
location of residence is critical for areas that are providing
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assistance in linking patients to care and for retention in care
activities as well as more accurate data on the number of persons
currently living with HIV in a jurisdiction to better focus care and
preventions services and target funding.
The Patient Identification and Health Department Use Only
sections of the ACRF and PCRF have been updated to add instructions
“(record all dates as mm/dd/yyyy)” to be consistent with all other
sections of the forms with dates that have guidance to inform the
user how to accurately record dates.
The facility type associated with the child’s facility of birth
was added to the Treatment/Services Referrals section on the ACRF
and the Birth History section on the PCRF. Health departments
currently capture facility type of birth in the NHSS. The form was
updated to allow a location for health departments to capture the
information for entry into the NHSS. Finally, the notation
indicating if a variable is transmitted to CDC (i.e., “*”) was
corrected for several variables. Medical record number and person
completing the form were removed from the State/Local Use Only
section of both the ACRF and PCRF because this information is
captured in the Patient Identification section and Facility
Providing Information section. The OI check boxes were removed for
opportunistic illnesses (OI) in the Clinical section on the ACRF and
PCRF to streamline format. Minor label edits are specified in Table
1.

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Summary of Revisions to the ACRF only
The HIV Testing and Antiretroviral Use History section of the
ACRF currently includes questions that capture whether a person has
ever taken antiretrovirals (ARVs) (for any purpose), the names of
the ARVs taken, the dates ARVs first began, and the dates of last
use. This section is being revised to collect information to monitor
and differentiate the reasons for ARV use: for HIV treatment, for
pre-exposure prophylaxis (PrEP), for post-exposure prophylaxis
(PEP), to prevent mother to child transmission during pregnancy, for
hepatitis B treatment, and, if needed, for other reason (reason to
be specified by surveillance staff completing the ACRF). The changes
to this section include separating out the questions related to HIV
testing and the questions related to ARV use to improve clarity and
readability. Response options in this section that previously
differentiated “Refused” from “Don’t Know/Unknown” have been
combined into a single response option with the label “Unknown” as
changes in data collection and analysis practices no longer require
differentiation between the two response options.
Summary of Revisions to the PCRF only
Within the Patient History section, the numbers preceding the
response options for the question “Child’s biological mother’s HIV
infection status” were removed. This change was made to minimize
potential errors when entering the information into the reporting
system. Three opportunistic infections (i.e., Carcinoma, invasive
cervical, M. tuberculosis, pulmonary X, and Pneumonia, recurrent in
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a 12 mo. period) were added to the Clinical section of the PCRF to
reflect the current HIV Surveillance Case Definition. In addition,
three date variables (i.e., “Date: _ _/_ _/_ _ _ _”) were removed from the
Services Referrals section and replaced with “Date began: _ _/_ _/_
_ _ _” and “Date of last use: _ _/_ _/_ _ _ _”. This change was made
to mirror what is planned for data collection in the next reporting
software update.

Summary of Revisions to the PHER Form
The top of the PHER form currently includes a space to write a
State Number; however it is not clear if this State Number belongs
to the infant or the mother. This section is being revised to
collect the infant and the mother’s state number to prevent
confusion and allow the user to link data from the PHER Form to the
ACRF and the PCRF. The City Number of the infant and the mother was
also added as this is the primary case identifier in some separately
funded cities.
Two questions on the PHER form were revised to correct skip
patterns. Question 8 was revised to capture any available toxicology
screen results on the mother (question 9) regardless of the answer
to question 8. A toxicology screen could have been done even if
evidence of substance use was omitted from the medical or social
work records. Question 15 was also revised to capture any available
birth information in question 17, regardless of whether the mother
was referred for HIV care post-delivery (question 15).

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The Antiretroviral Drugs section was entirely removed from the
PHER form, as the list of current ARVs is constantly evolving and we
are not able to keep up with the changes in real time. In addition,
we do not provide a list of drugs on the ACRF or PCRF and we want
these forms to be as consistent as possible.
Finally, the changes to the PHER form include revisions to the
formatting (e.g., inserted page numbers and corrected spacing
issues) to improve clarity and readability. The changes also include
minor modifications to update typographical errors (e.g., replaced
the reference to page 8 with a reference to page 4).
The previous burden associated with this ICR was 53,700 hours.
The total requested burden for this ICR is 50,504 hours. This
represents a reduction of 3, 194 hours or 6% decrease overall. The
decrease is largely due to decreases in the number of stage 3 (AIDS)
case reports nationally which is accounted for in our burden
calculations. Additionally, since the last ICR, CDC has made
improvements in national data processing resulting in improved data
quality and deduplication of cases which also contributes to
reduction in case counts used in our burden calculations. These
factors are counterbalanced by anticipated increases in laboratory
and case report updates among persons living with HIV and the burden
included for annual reporting of the SER and Laboratory Report and
APR. Together these factors result in a small overall change in the
burden requested in this ICR.

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Table 1. Proposed Modifications to the Adult HIV
Confidential Case Report Form (ACRF)*, Pediatric HIV
Confidential Case Report Form (PCRF)* and the Perinatal HIV
Exposure Reporting Form* (PHER)
Location in Document

Location in Document
Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section
Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section
Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section
Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section
Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section

Attachment 3a:
Top half of page 4;
Treatment/Services
Referrals section
Attachment 3a:
Top half of page 4; HIV
Antiretroviral Use
History section and HIV
Testing History section

Modifications to the ACRF Attachment 3(a), the PCRF
form Attachment 3(b) and PHER Attachment 3(d)
Modifications made only to the ACRF
•

Removed the words “the” and “section” from the
“For Children of Patient” header.

•

Changed the variable label from “Child Soundex” to
“Child’s Last Name Soundex”.

•

Added formatting to designate the date format to
be used for “Child’s Date of Birth” variable.
Inserted _ _/_ _/_ _.

•

Updated the variable label “Hospital of Birth (if
child was born at home, enter “home birth”)” to
“Facility Name of Birth (if child was born at
home, enter “home birth”)”.
Changed the variable label from “Hospital Name” to
“Facility Type”. Added selected facility type
categories and values. Included the category
"Inpatient" with the values of "Hospital" and
"Other, specify". Included the category
"Outpatient" with the value of "Other, specify".
Included the category "Other Facility" with the
values of "Emergency Room", "Corrections",
"Unknown", and "Other, specify".
Moved the variable label “Phone” up one line to
come after “Facility Name of Birth…”. Added the
standard designation for the phone number format
(i.e., Phone (
)_______).
Separated out the HIV testing-related questions
from the antiretroviral use-related questions in
the “HIV Testing and Antiretroviral Use History”
section and created two separate sections.
In the “HIV Antiretroviral Use History” section:
o Created section header “HIV Antiretroviral Use
History (record all dates as mm/dd/yyyy)”.
o Deleted “testing and treatment history” from the
first question, replacing with “antiretroviral
(ARV) use” and added a colon (:) at the end of
the first question, “Main source of testing and
treatment history information (select one)”.
o Removed “/PEMS” from the “NHM&E/PEMS” choice in
the first question.

•

•

•

•

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•

o Retained in first row “Date patient reported
information _ _ /_ _ /_ _ _ _”.
o In the second row, retained the question “Ever
taken any ARVs?”. Combined the response options
“Refused” and “Don’t Know/Unknown” into a single
response labeled “Unknown”.
o Added a third row of the “HIV Antiretroviral Use
History” section that modified the collection of
antiretroviral medications to include the reason
for antiretroviral use:
 “If yes, reason for ARV use (select all that
apply):”
□ HIV Tx ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
□ PrEP ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
□ PEP ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
□ PMTCT ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
□ HBV Tx ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
□ Other __________________ ARV medications:______
Date began: _ _ /_ _ /_ _ _ _
Date of last use: _ _ /_ _ /_ _ _ _
In the “HIV Testing History” section below the
“HIV Antiretroviral Use History” section:
o Revised existing section header “HIV Testing and
Antiretroviral Use History” (if required by
Health Department) (record all dates as
mm/dd/yyyy)” and deleted “and Antiretroviral
Use” and “(if required by Health Department)”.
o Deleted “and treatment” from the first question
and added a colon (:) at the end of the first
question, “Main source of testing and treatment
history information (select one)”.
o Removed “/PEMS” from the “NHM&E/PEMS” choice in
the first question.
o Combined the response options “Refused” and
“Don’t Know/Unknown” into a single response
option labeled “Unknown” for the questions “Ever
had previous positive HIV test”, “Ever had a
negative HIV test”, and “Number of negative HIV
tests within 24 months before first positive
test”.

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Location in Document
Attachment 3b:
Bottom half of page 2;
Patient History section

Modifications made only to the PCRF
•

Attachment 3b:
Bottom half of page 2;
Patient History section

•

Attachment 3b:
Bottom half of page 3;
Clinical section

•

Attachment 3b:
Bottom half of page 3;
Clinical section

•

Attachment 3b:
Bottom half of page 3;
Clinical section

•

Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases only)
section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section

•

Removed the number and hyphen (-) at the beginning
of each check box option associated with the
variable label “Child’s biological mother’s HIV
infection status (select one):”.
Removed extra space between “had” and
“HETEROSEXUAL” in the “Biological Mother had
HETEROSEXUAL relations with any of the following:”
header.
Added the following three OI's to the section:
“Carcinoma, invasive cervical”, “M. tuberculosis,
pulmonary†”, and “Pneumonia, recurrent in a 12 mo.
period”.
Removed columns 1 and 2 of the last row of the
section (i.e., Removed the variable label “Has
this child been diagnosed with pulmonary
tuberculosis?” along with the variable label
“Date”).
Shifted the text in column 3 of the last row of
this section (i.e., “If TB selected above,
indicate RVCT Case Number”) to the left and put
the text on one line as on the ACRF.
Added a header (in green) for “Residence at
Birth”.

•

Removed “Residence at Birth” variable label and
shifted the text “Check if SAME as Current
Address” to the left.

•

Changed the header (in green) from “Hospital of
Birth” to “Facility of Birth”.

•

Changed the variable label “Facility Name” to
“Facility Name of Birth (if child was born at
home, enter "home birth")”.

•

Added new variable “Facility Type” for consistency
with the revised ACRF.

•

Added an asterisk (*) at the beginning of “ZIP
Code”.

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Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Top half of page 4;
Birth History (for
Perinatal Cases
only)section
Attachment 3b:
Bottom half of page 4;
Services Referrals
section
Attachment 3b:
Bottom half of page 4;
Services Referrals
section
Attachment 3b:
Bottom half of page 4;
Services Referrals
section
Location in Document
Attachment 3a:
Bottom half of page 1,
2, 3, and 4; Footer
Attachment 3b:
Bottom half of page 1,
2, 3, and 4; Footer

•

Replaced the colon (:) with a question mark (?) at
the end of the variable label “Did mother received
any antiretrovirals (ARVs) prior to this
pregnancy:”.

•

Changed “Maternal Soundex” to “Maternal Last Name
Soundex”.

•

Removed the colon (:) at the end of the variable
label “*Other Maternal ID - List Type:”.

•

Removed the colon (:) at the end of the variable
label “Number”.

•

Removed the three date variables (i.e., “Date: _
_/_ _/_ _ _ _”) and replaced with “Date began: _
_/_ _/_ _ _ _” and “Date of last use: _ _/_ _/_ _
_ _”.
Shifted the “Yes” checkbox to the left for
“Neonatal ARVs for HIV prevention”.

•

Updated the revision date of the form from 3/2013
to 9/2015.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Removed the text “*Patient Name”. Shifted
remaining variables in the row to the left.

•

•

Shifted the “Yes” checkbox to the left for “Antiretroviral therapy for HIV treatment”.
Modifications to the ACRF and PCRF

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Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Added vertical lines to separate the variable
labels “First Name”, “Middle Name”, and “Last
Name” for the primary and alternate names
collected in the first two rows of the section.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Removed the asterisk (*) from the beginning of the
variable label “Alternate Name Type”.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Added text at the top of the section “(record all
dates as mm/dd/yyyy)”.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Changed variable label from “*Current Street
Address” to “*Current Address, Street”.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Added new variable “Address Date” after “Current
Address, Street”. Shifted “Phone”, “City”,
“County”, “State/Country” and “ZIP Code” to
account for the addition of the “Address Date”
variable.

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Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Removed the colon (:) at the end of the variable
labels “Other ID Type” and “Number”.

Attachment 3a:
Top half of page 1;
Patient Identification
section
Attachment 3b:
Top half of page 1;
Patient Identification
section

•

Added an asterisk (*) at the beginning of the
variable label “Number”.

Attachment 3a:
Top half of page 1;
Health Department Use
Only section
Attachment 3b:
Top half of page 1;
Health Department Use
Only section

•

Added text at the top of the section “(record all
dates as mm/dd/yyyy)”.

Attachment 3a:
Top half of page 1;
Facility Providing
Information section
Attachment 3b:
Top half of page 1;
Facility Providing
Information section

•

Added an asterisk (*) at the beginning of the
variable label “ZIP code”.

Attachment 3a:
Bottom half of page 1;
Patient Demographics
section
Attachment 3b:
Bottom half of page 1;
Patient Demographics
section

•

Removed the asterisks (*) before the variable
labels “Expanded Ethnicity” and “Expanded Race”.

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Attachment 3a:
Bottom half of page 1;
Residence at Diagnosis
section
Attachment 3b:
Bottom half of page 1;
Residence at Diagnosis
section

•

Added text at the top of the section “record all
dates as mm/dd/yyyy)”.

Attachment 3a:
Bottom half of page 1;
Residence at Diagnosis
section
Attachment 3b:
Bottom half of page 1;
Residence at Diagnosis
section

•

Added new variable “Address Date” after “Street
Address”.

Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Removed the text “-Provider identifier information
is not transmitted to CDC!-”.

Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Changed variable label from “Physician’s Name
(Last, First, M.I.)” to “Provider Name (Last,
First, M.I.)” and removed the colon (:) from the
end of the variable label. Added an asterisk (*)
before the variable label “Provider Name (Last,
First, M.I.)”.

Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Changed the variable label from “Phone No” to
“Phone” and removed the colon (:) from the end of
the variable label. Added an asterisk (*) before
the variable label “Phone”.

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Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Removed the variable “Medical Record No”.

Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Removed the colon (:) from the “Hospital/Facility”
variable label.

Attachment 3a:
Top half of page 2;
State/Local Use Only
section
Attachment 3b:
Top half of page 2;
State/Local Use Only
section

•

Removed the variable “Person Completing Form”.

Attachment 3a:
Top half of page 2;
Facility of Diagnosis
section
Attachment 3b:
Top half of page 2;
Facility of Diagnosis
section

•

Moved the text “(check all that apply to the
facility below)” to be directly after the variable
label before starting the checkboxes. Capitalized
the “C” in “check”. That is, updated to “(Check
all that apply to the facility below)”.

Attachment 3a:
Top half of page 2;
Facility of Diagnosis
section
Attachment 3b:
Top half of page 2;
Facility of Diagnosis
section

•

Added an asterisk (*) at the beginning of the
variable label “ZIP code”.

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Attachment 3a:
Top half of page 2;
Facility of Diagnosis
section
Attachment 3b:
Top half of page 2;
Facility of Diagnosis
section

•

Removed the asterisk (*) from the beginning of the
variable label “Specialty”.

Attachment 3a:
Bottom half of page 2;
Patient History section
Attachment 3b:
Bottom half of page 2;
Patient History section

•

Removed the word “section” from the variable label
“Received transfusion of blood/blood components
(other than clotting factor) (document reason in
Comments section)” to update to “Received
transfusion of blood/blood components (other than
clotting factor) (document reason in Comments)”.

Attachment 3a:
Bottom half of page 2;
Patient History section
Attachment 3b:
Bottom half of page 2;
Patient History section

•

Removed the word “section” from the variable label
“Other documented risk (please include detail in
Comments section)” to update to “Other documented
risk (please include detail in Comments)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Changed text at the top of the section from
“Laboratory Data (record additional tests in
Comments section) (record all dates as
mm/dd/yyyy)” to “Laboratory Data (record
additional tests and tests not specified below in
Comments) (record all dates as mm/dd/yyyy)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Changed the name of the first test category from
“HIV Antibody Tests (Non-type-differentiating)” to
“HIV Immunoassays (Non-differentiating)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Removed the block for TEST 3 and its result in the
first test category “HIV Immunoassays (Nondifferentiating)”.

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Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Removed “Other: Specify Test:___________” from the
TEST 1 and TEST 2 lines in the first test category
“HIV Immunoassays (Non-differentiating)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

De-emphasized the Rapid Test checkboxes by moving
them further to the right after the “Collection
Date” variable label, removing bold font, and
making proper case (i.e., “Rapid Test (check if
rapid)”) in the RESULT lines of the first test
category “HIV Immunoassays (Non-differentiating)”.
Removed the colon (:) at the end of the Rapid Test
checkbox labels.
Changed “Manufacturer__________________” to “Test
Brand Name/Manufacturer_____________________” in
the first test category “HIV Immunoassays (Nondifferentiating)”. Moved from the RESULT lines to
the TEST lines.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Changed the name of the second test category from
“HIV Antibody Tests (Type-differentiating) [HIV-1
vs. HIV-2]” to “HIV Immunoassays
(Differentiating)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Changed the TEST line to read “ HIV-1/2
Type-differentiating (Differentiates between HIV-1
Ab and HIV-2 Ab) Test Brand
Name/Manufacturer________________________” in the
second test category “HIV Immunoassays
(Differentiating)”. Also, removed the text “TEST”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Changed the result options to the following, with
a checkbox for each: “HIV-1”, “HIV-2”, “Both
(undifferentiated)”, “Neither (negative)”,
“Indeterminate” for the first test type in the
second test category “HIV Immunoassays
(Differentiating)”. Retained the text “RESULT:”,
and “Collection Date”. Added a Rapid Test checkbox
following “Collection Date” to read “
Rapid Test (check if rapid)”.

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Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Added a row to capture a second test type to read
“ HIV-1/2 Ag/Ab-differentiating
(Differentiates between HIV Ag and HIV Ab) Test
Brand Name/Manufacturer________________________”
under the second test category “HIV Immunoassays
(Differentiating)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Added a row to capture a second result with a
checkbox for: “Ag reactive”, “Ab reactive”, “Both
(Ag and Ab reactive)”, “Neither (negative)”,
“Invalid/Indeterminate” for the second test type
in the second test category “HIV Immunoassays
(Differentiating)”. Added the text “RESULT:”, the
“Collection Date” variable, and Rapid Test
checkbox.
Added a row to capture a third test type to read
“ HIV-1/2 Ag/Ab and Type-differentiating
(Differentiates among HIV-1 Ag, HIV-1 Ab, and HIV2 Ab) Test Brand
Name/Manufacturer________________________” under
the second test category “HIV Immunoassays
(Differentiating)”.

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Added a row to capture a third result in the
second type category “HIV Immunoassays
(Differentiating)” with the row titled “Result*:”.
Added two components: “HIV-1 Ag” and “HIV Ab”.
Response options for “HIV-1 Ag” were “Reactive”,
“Nonreactive”, “Not Reported”, with a checkbox for
each. Response options for “HIV Ab” were “HIV-1
Reactive”, “HIV-2 Reactive”, “Both Reactive,
Undifferentiated”, “Both Nonreactive”, with a
checkbox for each. Added Collection Date. Added
instructions “*Select one result for HIV-1 Ag and
one result for HIV Ab”.
Changed the text from “TEST 1:” to “TEST” under
the third test category “HIV Detection Tests
(Qualitative).

Removed the block for TEST 2 and its RESULT under
the third test category “HIV Detection Tests
(Qualitative)”.

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11/13/2015

Attachment 3a:
Top half of page 3;
Laboratory Data section
Attachment 3b:
Top half of page 3;
Laboratory Data section

•

Removed “HIV-1 P24 Antigen” from the TEST row
under the third test category “HIV Detection Tests
(Qualitative)”.

Attachment 3a:
Bottom half of page 3;
Laboratory Data section
Attachment 3b:
Bottom half of page 3;
Laboratory Data section

•

Changed “CD4 at or closest to current diagnostic
status” to “CD4 at or closest to diagnosis” under
the fifth test category “Immunologic Tests (CD4
count and percentage)”.

Attachment 3a:
Bottom half of page 3;
Laboratory Data section
Attachment 3b:
Bottom half of page 3;
Laboratory Data section

•

Removed “p24 Ag” from the text line “Complete the
above only if none of the following was positive…”
under the “Documentation of Tests” header.

Attachment 3a:
Bottom half of page 3;
Laboratory Data section
Attachment 3b:
Bottom half of page 3;
Laboratory Data section

•

Removed the colon at the end of the last line of
the first row under the “Documentation of Tests”
heading in the section. The phrase was updated as
follows: “Complete the above only if none of the
following was positive: HIV-1 Western blot, IFA,
culture, viral load, or qualitative NAAT [RNA or
DNA]”.

Attachment 3a:
Bottom half of page 3;
Clinical section
Attachment 3b:
Bottom half of page 3;
Clinical section

•

Removed the three “OI” columns.

Attachment 3a:
Bottom half of page 4;
Comments section
Attachment 3b:
Bottom half of page 4;
Comments section

•

Removed the asterisk (*) at the beginning of
header.

Attachment 3a:
Bottom half of page 4;
Comments section
Attachment 3b:
Bottom half of page 4;
Comments section

•

Decreased the number of lines allowed for entry in
the “Comments” section.

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11/13/2015

Attachment 3a:
Bottom half of page 4;
Local/Optional Fields
section
Attachment 3b:
Bottom half of page 4;
Local/Optional Fields
section
Location in Document

•

Attachment 3d:
Top half of page 1;
Header

•

Added “Infant’s” before “State Number”.

Attachment 3d:
Top half of page 1;
Header

•

Added “Mother’s State Number_________”.

Attachment 3d:
Top half of page 1;
Header

•

Added “Infant’s City Number __________”.

Attachment 3d:
Top half of page 1;
Header
Attachment 3d:
Top half of page 1;
Question 4
Attachment 3d:
Bottom half of page 1;
Question 7
Attachment 3d:
Bottom half of page 1;
Question 7
Attachment 3d:
Bottom half of page 1;
Footer

•

Added “Mother’s City Number __________”.

•

Changed “test performed” to “test(s) performed”.

•

Changed “State No.” to “State Number” and “City
No.” to “City Number”.

•

Updated the “(See list.)” under HIV serostatus to
“(See list below)”.

•

Changed the first sentence of the privacy
statement to: “Public reporting burden of this
collection of information is estimated to average
30 minutes per response, including the time for
reviewing instructions, searching existing data
sources, gathering and maintaining the data
needed, and completing and reviewing the
collection of information.”

Attachment 3d:
Bottom half of page 1,
2, 3, and 4; Footer

•

Added page numbers (e.g., Page 1 of 4) to improve
the user’s ability to locate and reference
questions.

Attachment 3d:
Top half of page 2;
Question 8

•

Replaced “No (Go to 10.)” with “No (Go to 9)”.

Decreased the number of lines allowed for entry in
the “Local/Optional Fields” section.

Modifications to the PHER Form

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Attachment 3d:
Top half of page 2;
Question 8, Question 9,
and Question 10
Attachment 3d:
Top half of page 2;
Question 9

•

Removed the extra line under “Specific drug(s) not
documented”.

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Top half of page 2;
Question 9 and Question
10

•

Moved the checkbox for “No” under the “Yes,
negative result” checkbox and moved “Toxicology
screen not documented” under “No”.

Attachment 3d:
Top half of page 2;
Question 10

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Bottom half of page 2;
Question 11

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Bottom half of page 2;
Question 12

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Bottom half of page 2;
Question 12
Attachment 3d:
Bottom half of page 2;
Question 12

•

Added “(Go to 13)” after the “Unknown” checkbox.

•

Removed the “See list on p.8” under “Drug name”.

Attachment 3d:
Bottom half of page 2;
Question 12

•

Removed the column for “Other (specify)” and
merged lines i through vi for the two columns.

Attachment 3d:
Bottom half of page 2;
Question 12

•

Replaced “Stop codes (See list on p. 8)” with
“Stop codes (See list on p. 4)”.

Attachment 3d:
Top half of page 3;
Question 14a

•

Inserted space below questions (similar to Q15).

Attachment 3d:
Top half of page 3;
Question 14

•

Added “(Go to 15)” after the “Unknown” checkbox.

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11/13/2015

Attachment 3d:
Top half of page 3;
Question 14

•

Removed the extra space between “Record not
available” and “(Go to 15)”.

Attachment 3d:
Top half of page 3;
Question 14

•

Removed the “See list on p.8” under “Drug name”.

Attachment 3d:
Top half of page 3;
Question 14

•

Removed the column for “Other (specify)” and
merged lines i through vi for the two columns.

Attachment 3d:
Top half of page 3;
Question 15

•

Replaced “No (Go to 18.)” with “No (Go to 17)”.

Attachment 3d:
Top half of page 3;
Question 15

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Top half of page 3;
Question 16

•

Attachment 3d:
Top half of page 3;
Question 16

•

Added “the mother’s” to the question: “If yes,
indicate first CD4 result or first viral load
after discharge from hospital (up to 6 months
after discharge)”. Example: “If yes, indicate the
mother’s first CD4 result or first viral load
after discharge from hospital (up to 6 months
after discharge)”.
Replaced “Viral load” with “Viral load result”.

Attachment 3d:
Top half of page 3;
Question 16

•

Inserted space below questions (similar to Q15).

Attachment 3d:
Bottom half of page 3;
Question 18

•

Moved “Not applicable” under “Not specified”.

Attachment 3d:
Bottom half of page 3;
Question 18

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Bottom half of page 3;
Question 19

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

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11/13/2015

Attachment 3d:
Bottom half of page 3;
Question 19

•

Inserted space below questions (similar to Q15).

Attachment 3d:
Top half of page 4;
Question 20

•

Removed the “See list on p.8” under “Drug name”.

Attachment 3d:
Top half of page 4;
Question 20

•

Removed the column for “Other (specify)” and
merged lines i through vi for the two columns.

Attachment 3d:
Top half of page 4;
Question 20

•

Updated the spacing so it is consistent between
the five responses (e.g., between “Record not
available” and “Unknown”).

Attachment 3d:
Top half of page 4;
Question 20

•

Changed “(See list on p. 4)” under Stop codes to
“(See list)”.

Attachment 3d:
Top half of page 4;
Question 20

•

Moved the checkboxes to the left (so the first one
lines up directly under the text as in Q1).

Attachment 3d:
Bottom half of page 4

•

Removed the Antiretroviral drugs section entirely.

Attachment 3d:
Bottom half of page 4;
List of Abbreviations
section

•

Removed all of the abbreviations from the list
except for the five abbreviations that are
referenced in the form.

Attachment 3d:
Bottom half of page 4;
Comments section

•

Added the text “Comments” to the beginning of the
section.

Attachment 3d:
Bottom half of page 4;
Comments section

•

Moved the comments to the last section on page. 4.

*Note the revised Adult HIV Confidential Case Report Form (ACRF)
is provided in Attachment 3(a) and the revised Pediatric HIV
Confidential Case Report Form (PCRF) is provided in Attachment
3(b) and the revised Perinatal Exposure Reporting (PHER) form is
provided in Attachment 3(d).

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11/13/2015