Revised M&E variables with proposed edits

Form Approved

OMB No. 0920-1178

Exp. Date 04/30/2020

ATTACHMENT 4: Semi-annual Reporting of Monitoring and Evaluation (M&E) Variables – File Specifications

Note: This attachment represents guidance for collecting information about HIV prevention and care services

Public reporting burden of this collection of information varies from 1 to 9 hours 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. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1178)

In Attachment 4, data variables on HIV prevention and care services provided to the target population are listed. These are the required variables that will be reported twice a year by all THRIVE grantees via secure File Transfer Protocol (FTP) to the Division of HIV/AIDS Prevention at CDC.

Revisions

There were 11 variables that were added in this amendment (see Table 1):

• Added question on facilitators for adhering to PrEP(2M.1 & 2M.2)

• Added questions on SBIRT variables to section 12 (12S1-12S4)

• Added question on whether same day ART was offered (4A.1)

• Added question on whether same day ART was accepted (4A.2)

• Added question on whether financial incentives were provided (4A.3)

• Added question on was creatinine testing conducted (1k)

• Added question on date of creatinine test (1L)

There were 6 variables that were deleted from the list of variables previously approved by the OMB (see 5B.2-5H in Table 1)

In addition, we made the following clarifications to the list of variables previously approved by the OMB (see Table 1):

• Given the complexity of sex and gender and the focus of this project on a specific target population (men who have sex with men), we added to “section A. Demographics” (i.e., added an “othergender” and “sex at birth” variable; revised transgender labels, added a variable to assess the sex/gender of sexual partners, and a “year at birth” variable)

• To be conclusive of all types of HIV tests funded sites might use, we expanded the previously approved options for “types of HIV tests” (1A.2) to include “Western Blot” and “Geenius”

• In response to some funded sites’ difficulty in tracking client initiation of some medications, we separated out “prescription” and “initiation” for PrEP (2G.1 & 2), nPEP (3G.1 & 2), and ARVs (4B.1 & 2)

• Corrected an error: Replaced “early infection” with “recent infection” throughout the assessment

• Listed all types of STD infections for the previously approved variable “Screened positive for one or more STDs” (section 8B.)

• Included a missing step of the HIV prevention and treatment continuum – linkage. “Linkage” was included for previously approved variables in this continuum (i.e., yes/no questions for linkage to HIV testing [1A.1 & 2], medication adherence support [6A.1 & 2], retention intervention [7A.1 & 2] and evidence-based behavior risk-reduction counseling [10A. 1 & 2])

• Included a missing step of the HIV treatment continuum – identification of HIV positive persons out of care (5A.1)

Table 1. Semi-annual Reporting of Monitoring and Evaluation (M&E) Variables

***NOTE: revised text appears in red font

Demographic information (Client-level data)
A1	Unique Client ID ____________	A2	Year of birth ______	A3	Ethnicity Categories Hispanic Non-Hispanic	A4	Race Categories (check all that apply) American Indian/Alaska Native Asian Black/African American Native Hawaiian/Pacific Islander White

A5	Current gender Categories Male Female Transgender woman (male to female) Transgender male (female to male) Another/other gender Unknown	A6	Sex at Birth Categories Male Female Intersex	A7	Sexual Behavior (past and present) Categories Sex with male(s) only Sex with female(s) only Sex with male(s) and female(s) Sex with transgender woman (MtF) Sex with transgender man (FtM) Sex with another/other gender	A8	Recent Sexual Behavior (past 12 months) Categories (check all that apply) Sex with male(s) only Sex with female(s) only Sex with male(s) and female(s) Sex with transgender woman (MtF) Sex with transgender man (FtM) Sex with another/other gender

B	Services for Persons at Risk for HIV	Variable Type
	1. HIV Testing (Client-level data) Answer 1A-1J for each HIV screening event
1A	Date screened for HIV (regardless of test technology)	Date
1A.1	Was this client linked to HIV testing?	Category
1A.2	Was a navigator used to link client to HIV testing?	Category
1B	Type of test Categories Conventional 4th generation lab-based Rapid 4th generation point-of-care NAAT/RNA testing Western Blot Geenius HIV-1/2 differentiation assay Other____________	Category, subcategory
1C	Result of HIV test Categories Positive/reactive Negative Indeterminate Invalid No result	Category
1D	If positive, type of diagnosis Categories New Prior	Category
1E	If new diagnosis, type of HIV infection Categories Acute Recent Established Unknown	Category
1F	Date diagnosed with acute HIV infection	Date
1G	Date diagnosed with recent HIV infection	Date
1H	Date diagnosed with established HIV infection	Date
1I	Newly diagnosed HIV infection identified (regardless of test technology)	Yes/No/NA/DK
1J	Previously diagnosed HIV infection identified (regardless of test technology)	Yes/No/NA/DK
1K	Was creatinine (Cr) testing conducted as part of THRIVE services? (all that apply)	a.  No b.  Yes, as part of PrEP screening  - Point of care  Cr testing c.   Yes, as part of PrEP screening -  Lab-based Cr testing d.  Yes, as part of nPEP screening – Point of care Cr testing e. Yes, as part of nPEP screening – Lab-based Cr testing f.             Other, please specify______________________
1L	Date of creatinine test	Date
C	Services for HIV-Negative Persons
	2. Screening and Provision of PrEP Services (Cascading) (Client-level data) Answer 2A-2P for each PrEP screening event
2A	Date screened for PrEP eligibility	Date
2B	Eligible for PrEP	Yes/No/NA/DK
2C	Referred to an internal or external PrEP provider	Yes/No/NA/DK Date (if yes)
2D	Accepted PrEP referral	Yes/No/NA/DK Date (if yes)
2E	Linked with a PrEP provider	Yes/No/NA/DK Date (if yes)
2F	Clinically assessed for PrEP indication	Yes/No/NA/DK Date (if yes)
2G.1	Prescribed PrEP	Yes/No/NA/DK Date (if yes)
2G.2	Initiated PrEP	Yes/No/NA/DK Date (if yes)
2H	Provided PrEP adherence support intervention	Yes/No/NA/DK
2I	Date filled initial PrEP prescription	Date
2J	Dates of follow-up clinic visits	Date
2K	Dates PrEP prescriptions were refilled	Date
2L	Dates assessed for adherence to PrEP	Date
2M	Adherent (answer for each adherence assessment)	Yes/No/NA/DK
2M.1	If Adherent, What was the main reason you were able to remain adherent to PrEP? (select one) Categories Navigator Have insurance Reminder text Developed routine schedule (ie calender reminder) Other_______________________	Category
2M.2	If Adherent, What were additional reasons you were able to remain adherent to PrEP? (select all that apply) Categories Navigator Have insurance Reminder text Developed routine schedule (ie calender reminder) Other_______________________	Category
2N	Date PrEP stopped	Date
2O	Primary reason for stopping PrEP (select one) Categories No longer at risk HIV positive Side effects Cannot afford Lost health insurance Provider no longer available Did not fill prescriptions Cannot remember to take pills Stigma Other ________________________	Category
2P	Additional reason(s) for stopping PrEP (select all that apply) Categories No longer at risk HIV positive Side effects Cannot afford Lost health insurance Provider no longer available Did not fill prescriptions Cannot remember to take pills Stigma Other ________________________	Category
	PrEP Capacity (Program-level data)
2Q	Number of staff hired/newly reassigned to THRIVE during the measurement period	Number
2R	Number of vacancies during the measurement period	Number
2S	Number of trainings conducted for staff during the measurement period	Number
2T	Number staff trained during the measurement period	Number
2U	Number of training sites in the collaborative during the measurement period	Number
2V	Number of new contracts executed during the measurement period	Number
2W	Number of new sites that are implementing PrEP activities during the measurement period	Number
	PrEP Awareness and Knowledge (Program-level data)
2X	Number of activities implemented to increase awareness and knowledge during the measurement period	Number
2Y	Number of times a target populations (populations of MSM, by race/ethnicity) was reached for each activity during the measurement period	Number
2Z	Number of the type of media placements used during the measurement period	Number
2AA	Number of persons reached by each activity during the measurement period	Number
	3. Screening and Provision of nPEP Services (Cascading) (Client-level data) Answer 3A-3N for each nPEP screening event
3A.1	Screened for nPEP eligibility	Yes/No/NA/DK
3A.2	Date screened for nPEP eligibility	Date
3B	Eligible to be clinically assessed for nPEP	Yes/No/NA/DK Date (if yes)
3C	Referred to an internal or external nPEP provider	Yes/No/NA/DK Date (if yes)
3D	Accepted nPEP referral	Yes/No/NA/DK Date (if yes)
3E	Linked with a nPEP provider	Yes/No/NA/DK Date (if yes)
3F	Clinically assessed for nPEP indication	Yes/No/NA/DK Date (if yes)
3G.1	Prescribed nPEP	Yes/No/NA/DK Date (if yes)
3G.2	Initiated nPEP	Yes/No/NA/DK Date (if yes)
3H	Date filled nPEP prescription	Date
3I	Provided adherence support intervention	Yes/No/NA/DK
3I.1	If Adherent, What was the main reason you were able to remain adherent to nPEP? (select one) Categories Navigator Have insurance Reminder text Developed routine schedule (ie calender reminder) Other_______________________	Category
3I.2	If Adherent, What were additional reasons you were able to remain adherent to nPEP? (select multiple reasons) Categories Navigator Have insurance Reminder text Developed routine schedule (ie calender reminder) Other_______________________	Category
3J	Date(s) of clinic visits during the 28-day course	Date(s)
3K	Number of days missed of 28-day nPEP course	Number
3L	Date of clinic visit after 28-day nPEP course	Date
3M	Primary reason for stopping nPEP (select one) Categories HIV positive Side effects Cannot afford No health insurance Provider no longer available Did not fill prescription Cannot remember to take pills Stigma Other_______________________	Category
3N	Additional reason for stopping nPEP (select multiple reasons) Categories HIV positive Side effects Cannot afford No health insurance Provider no longer available Did not fill prescription Cannot remember to take pills Stigma Other_______________________	Category
	nPEP Capacity (Program-level data)
3O	Number of staff hired or newly reassigned during the measurement period	Number
3P	Number of vacancies/Number staff resigned during the measurement period	Number
3Q	Number of trainings conducted during the measurement period	Number
3R	Number staff trained during the measurement period	Number
3S	Number of facilities/ practices trained during the measurement period	Number
3T	Number of new contracts executed during the measurement period	Number
3U	Number of new sites that are implementing nPEP activities during the measurement period	Number
	nPEP Awareness and Knowledge (Program-level data)
3V	Number of activities implemented to increase nPEP awareness and knowledge during the measurement period	Number
3W	Number of times a target population (populations of MSM, by race/ethnicity) was reached for each activity during the measurement period	Number
3X	Number and type of media placements utilized during the measurement period	Number
3Y	Number of people reached by each activity during the measurement period	Number
D	Services for HIV-Positive Persons
	4. Linkage to Care, Provision of ARVs, HIV viral load and CD4 testing for Persons with Newly Diagnosed or Established HIV infection (Client-level data)
4A	Linked to care (attended an HIV medical care visit)	Date
4A.1	Offered Same day ART at the time of their HIV diagnosis	Category
4A.2	If offered same day ART, was it accepted?	Category
4A.3	Were Financial incentives provided (for re-engage, linked to care, retained in care, and viral suppression)	Category
4B.1	Date prescribed ARVs	Date
4B.2	Date initiated ARVs	Date
4C	Date of HIV viral load test performed at entry into care	Date
4D	HIV viral load	Number
4E	Dates of HIV viral load test performed during HIV care	Date
4F	HIV viral load (report for each test date)	Number
4G	Date of CD4 count performed at entry into care	Date
4H	CD4 count	Number
4I	Dates of CD4 count performed during HIV care (for person with acute HIV infection)	Date
4J	CD4 count (report for each test date)	Number
	5. Linkage or Re-engagement with Care, Provision of ARVs, HIV viral load and CD4 testing for Previously Diagnosed Persons Not-in-Care (Client-level data)
5A.1	How was the previously diagnosed client identified and determined to be out of care?	Category
5A.2	Date linked to or re-engaged with care (attended at least one HIV medical care visit) if previously diagnosed with HIV infection, identified by HIV testing and determined to not be in care	Date
5B.1	Date prescribed ARVs if previously diagnosed HIV infection, identified through HIV testing and determined to not be in care	Date
5B.2	Date initiated ARVs if previously diagnosed HIV infection, identified through HIV testing and determined to not be in care	Date
5C	Date of HIV viral load test performed after linkage or re-engagement if previously diagnosed with HIV infection, identified by HIV testing and determined to not be in care.	Date
5D	HIV viral load	Number
5E	Date of CD4 count performed after linkage or re-engagement if previously diagnosed with HIV infection, identified by HIV testing and determined to not be in care.	Date
5F	CD4 count	Number
5G	Date linked to or re-engaged with care (attended at least one HIV medical care visit) if previously diagnosed HIV infection, identified through data-to-care activities and determined to be not in care after being contacted by program staff	Date
5H	Date initiated on ARVs if previously diagnosed with HIV infection, identified through data-to-care activities and determined to not be in care after being contacted by program staff	Date
5I	Dates of HIV viral load test performed after linkage or re-engagement if previously diagnosed with HIV infection, identified by data-to-care activities and determined to be not in care after being contacted by program staff	Date
5J	HIV viral load (report for each test date)	Number
5K	Dates of CD4 count performed after linkage or re-engagement if previously diagnosed with HIV infection, identified by data-to-care activities and determined to be not in care after being contacted by program staff	Date
5L	CD4 count (report for each test date)	Number
5M	Previously diagnosed with HIV infection and Identified by HIV testing and determined to not be in care	Yes/No/NA/DK
5N	Previously diagnosed HIV infection and identified by data-to-care activities and determined to be not-in-care	Yes/No/NA/DK
5O	Previously diagnosed HIV infection and identified by data-to-care activities who were contacted by program staff	Yes/No/NA/DK
	6. ART Adherence Support Services (Client-level data)
6A	Date(s) received medication adherence support intervention	Date
6A.1	Was a navigator used to link client to a medication adherence support intervention?	Category
6A.2	Was this client linked to a medication adherence support intervention (attended a medication adherence intervention session/visit)	Category
	7. Retention in Care (Client-level data)
7A	Date(s) received retention intervention	Date
7A.1	Was a navigator used to link client to a retention intervention?	Category
7A.2	Was this client linked to a retention intervention (attended a retention intervention session/visit)	Category
7B	Date(s) of HIV medical care visits	Date
E	Services for HIV-Positive and HIV-Negative persons
	8. STD Screening and Treatment (i.e., Syphilis, Gonorrhea, and Chlamydia Infections) (Client-level data) Includes genital and extragenital screening for Gonorrhea and Chlamydia.Answer 8A-9C for each STD screening event
8A	Date screened for STDs	Date
8B	Screened positive for one or more STDs	Yes/No/NA/DK
8B.1	Patient screened for syphilis?	Category
8B.2	Patient screened for gonorrhea?	Category
8B.3	Patient screened for Genital or Rectal Chlamydia?”	Category
8C	Referred to STD treatment provider if screened positive for one or more STDs	Yes/No/NA/DK Date (if yes)
8D	Linked to an STD treatment provider if screened positive for one or more STDs	Yes/No/NA/DK Date (if yes)
8E	Received STD treatment if screened positive for one or more STDs	Yes/No/NA/DK Date (if yes)
	9. HIV Partner Services (PS) and STD (Client-level data)
9A	Date interviewed for HIV partner services	Yes/No/NA/DK Date (if yes)
9B	Number of partners named by persons	Number
9C	Date diagnosed with STD (by syphilis, gonorrhea, chlamydia)	Date
	10. Risk Reduction Interventions (Client-level data)
10A	Date(s) received evidence-based behavioral risk reduction counseling or interventions if enrolled in the project	Date
10A.1	Was a navigator used to link client to evidence-based behavioral risk-reduction counseling or interventions?	Category Yes/No/NA/DK
10A.2	Was this client linked to evidence-based behavioral risk-reduction counseling or interventions	Category Yes/No/NA/DK
Behavioral Health Services Screening, Social Services Screening, and Linkage Services Answer 11A-18E for each screening event
	Date screened for Behavioral Health and Social Service Services (by service type)	Date
	11. Behavioral Health Screening and Linkage - Mental Health Services (Client-level data)
11A	Screened for mental health service needs if enrolled in the project	Yes/No/NA/DK
11B	Found to have an unmet need if screened for mental health services	Yes/No/NA/DK
11C	Referred to mental health service provider if found to have with unmet mental health service need	Yes/No/NA/DK Date (if yes)
11D	Linked to a mental health service provider if found to have with unmet mental health service need	Yes/No/NA/DK Date (if yes)
11E	Received mental health services, including treatment if found to have with unmet mental health service need	Yes/No/NA/DK Date (if yes)
	12. Behavioral Health Screening and Linkage -Substance Abuse Services (Client-level data)
12A	Screened for substance abuse service needs if enrolled in the project	Yes/No/NA/DK
12B	Found to have unmet needs if screened for substance abuse service needs	Yes/No/NA/DK
12C	Referred to substance abuse service provider if found to have substance abuse service needs	Yes/No/NA/DK Date (if yes)
12D	Linked to a substance abuse service provider if found to have substance abuse service needs	Yes/No/NA/DK Date (if yes)
12E	Received substance abuse services, including treatment if found to have substance abuse service needs	Yes/No/NA/DK Date (if yes)
12S.1	Was Screening, Brief Intervention and Referral to Treatment (SBIRT) provided	Yes/No/NA/DK Date (if yes)
12S.2	Referred to a Substance Abuse and Mental Health Services Administration (SAMHSA) treatment center	Yes/No/NA/DK Date (if yes)
12S.3	Linked to a SAMHSA treatment center	Yes/No/NA/DK Date (if yes)
12S.4	Received substance abuse services, including treatment if found to have substance abuse service needs at a SAMHSA treatment center	Yes/No/NA/DK Date (if yes)
	13. Social Service Screening and Linkage - Housing Services (Client-level data)
13A	Screened for housing needs if enrolled in the project	Yes/No/NA/DK
13B	Found to have unmet housing needs if screened for housing needs	Yes/No/NA/DK
13C	Referred to housing assistance provider if found to have unmet housing needs	Yes/No/NA/DK Date (if yes)
13D	Linked to a housing assistance provider if found to have unmet housing needs	Yes/No/NA/DK Date (if yes)
13E	Received housing assistance if found to have unmet housing needs	Yes/No/NA/DK Date (if yes)
	14. Social Service Screening and Linkage -- Employment/Job Training (Client-level data)
14A	Screened for employment assistance/job training needs if enrolled in the project	Yes/No/NA/DK
14B	Found to have unmet employment assistance/job training needs if screened for employment assistance/job training needs	Yes/No/NA/DK
14C	Referred to employment assistance/job training provider if found to have unmet employment assistance/job training needs	Yes/No/NA/DK Date (if yes)
14D	Linked to employment assistance/job training provider if found to have unmet employment assistance/job training needs	Yes/No/NA/DK Date (if yes)
14E	Received employment assistance/job if found to have unmet employment assistance/job training needs	Yes/No/NA/DK Date (if yes)
	15. Social Service Screening and Linkage – Transportation (Client-level data)
15A	Screened for transportation assistance needs if enrolled in the project	Yes/No/NA/DK
15B	Found to have unmet transportation assistance needs if screened for transportation assistance needs	Yes/No/NA/DK
15C	Referred to transportation assistance provider if found to have unmet transportation assistance needs	Yes/No/NA/DK Date (if yes)
15D	Linked to a transportation assistance provider if found to have unmet transportation assistance needs	Yes/No/NA/DK Date (if yes)
15E	Received transportation assistance if found to have unmet transportation assistance needs	Yes/No/NA/DK Date (if yes)
	16. Social Service Screening and Linkage – Education (Client-level data)
16A	Screened for education assistance needs if enrolled in the project	Yes/No/NA/DK
16B	Found to have unmet education assistance needs if screened for education assistance needs	Yes/No/NA/DK
16C	Referred to education assistance provider if found to have unmet education assistance needs	Yes/No/NA/DK Date (if yes)
16D	Linked to an education assistance provider if found to have unmet education assistance needs	Yes/No/NA/DK Date (if yes)
16E	Received education assistance if found to have unmet education assistance needs	Yes/No/NA/DK Date (if yes)
F	Navigation Services
	17. Navigation for Health Services (Client-level data)
17A	Received navigation (by type of service) to link to needed services if enrolled in the project	Yes/No/NA/DK Date (if yes)
	18. Navigation for Health Insurance Screening and Linkage (Client-level data)
18A	Screened for health insurance needs if enrolled in the program through HIV testing or data-to-care activities	Yes/No/NA/DK
18B	Screened for health insurance needs (including those in need of financial assistance for PrEP/ARVs) if uninsured or underinsured	Yes/No/NA/DK
18C	Referred to health insurance navigator if found to have unmet health insurance needs (uninsured/underinsured)	Yes/No/NA/DK Date (if yes)
18D	Linked to health insurance navigator if found to have unmet health insurance needs (uninsured/underinsured)	Yes/No/NA/DK Date (if yes)
18E	Enrolled in health insurance plan or provided financial assistance for prescriptions if found to have unmet health insurance needs (uninsured/underinsured)	Yes/No/NA/DK Date (if yes)
G	Billing/Re-imbursement, Capacity-Building, and Collaborations
	19. Billing/Reimbursement for Services (Program-level data)
19A	Number of HIV tests conducted during the measurement period that were billed to or reimbursed by a third-party payer	Number
19B	Number of STD tests conducted during the measurement period that were billed to or reimbursed by a third-party payer	Number
19C	Number of persons on nPEP during the measurement period whose nPEP clinical services were billed to or reimbursed by a third-party payer	Number
19D	Number of persons on PrEP during the measurement period whose PrEP clinical services were billed to or reimbursed by a third-party payer	Number
	20. Project Related Training (Program-level data)
20A	Number of project related trainings conducted by purpose/focus of training (e.g., cultural competency, HIV testing, navigation, etc.)	Number
20B	Number of health department and collaborative agency staff trained	Number
	21. Project Staffing (Program-level data)
21A	TOTAL Number of health department and collaborative agency staff newly hired or re-assigned to work on project	Number
	22. Contracts and Partnerships (Program-level data)
22A	Total number of new contracts awarded to implement project activities	Number
22B	Total number of CBOs funded to work on project activities	Number
22C	Total number of organizations (other than funded CBOs) that partnered with the health department to implement project activities	Number

Abbreviations: DK - Don’t know; NA - Not Applicable

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