Revised M&E variables with proposed edits

Att 4 REVISED_ME Variables.docx

Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color

Revised M&E variables with proposed edits

OMB: 0920-1178

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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

  1. 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

2


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