Form 0920-22FZ Att 4l_Clinic Assessment Baseline and Final

Form Approved

OMB No. 0920-New

Expiration Date: XX/XX/XXXX

mChoice: Improving PrEP Uptake and Adherence among Minority MSM through

Provider Training and Adherence Assistance in Two High Priority Settings

Attachment 4l

Clinic Assessment Baseline and Final

Public reporting burden of this collection of information is estimated to average 120 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. 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: OMB-PRA (0920-New)

Clinic Assessment Baseline and Final

*Note this assessment does not need to be completed for satellite or affiliate clinics.

Instructions: Clinic staff should complete at the beginning (start of provider training) and end of data collection (end of patient cohort follow-up).

Clinic Information

1. Name of clinic

2. Address

3. Days and hours of operation

4. Does your clinic provide bilingual services?

5. What mode of healthcare delivery is your clinic currently using?

   1. In-person

   2. Telemedicine

   3. Both

      1. Estimated percentage of healthcare delivery that is in-person

      2. Estimated percentage of healthcare delivery that is telemedicine (includes both telephone and teleconferencing)

6. Estimated percentage of patient care revenue

Payer type	%
Private insurance
Medicaid/Medicare
Patient payments
Other

7. Number of clinical providers¹

8. Number of clinical providers¹ who prescribed PrEP in the last 6 months

9. Does your clinic have an in-house pharmacy?

   1. If yes, does it dispense PrEP medications?

10. Does your clinic provide transportation support (e.g., gas vouchers, medical transport) for PrEP appointments?

¹ Persons with capacity to prescribe medications

PrEP Prescriptions²

11. PrEP prescriptions current calendar year to date

PrEP Regimen	All Clients	Clients 18-39 years	Men who have sex with men (MSM) 18- 39 years	Black MSM 18-39 years	Hispanic/Latino MSM 18-39 years
F/TDF: Emtricitabine co- formulated with tenofovir disoproxil fumarate (trade name Truvada®), prescribed daily
F/TDF: Emtricitabine co- formulated with tenofovir disoproxil fumarate (generic), prescribed daily
F/TAF: Emtricitabine co- formulated with tenofovir alafenamide (trade name Descovy®)
F/TDF: Prescribed for intermittent use (2-1-1 or event-driven PrEP)
CAB: Cabotegravir intramuscular injections

12. PrEP prescriptions prior calendar year

² Count of all prescriptions provided, may exceed number of PrEP patients as a patient may receive >1 type of PrEP in the time period

PrEP Regimen	All Clients	Clients 18-39 years	Men who have sex with men (MSM) 18- 39 years	Black MSM 18-39 years	Hispanic/Latino MSM 18-39 years
F/TDF: Emtricitabine co- formulated with tenofovir disoproxil fumarate (trade name Truvada®), prescribed daily
F/TAF: Emtricitabine co- formulated with tenofovir alafenamide (trade name Descovy®)
F/TDF: Prescribed for intermittent use (2-1-1 or event-driven PrEP)
CAB: Cabotegravir intramuscular injections

Clinical Services

13. HIV tests³ current calendar year to date (excluding testing for persons with previously diagnosed HIV infection)

HIV Test

All Clients

Clients 18-39 years

Men who have sex with men (MSM) 18-39 years

Black MSM 18-39 years

Hispanic/Latino MSM 18-39 years

³ Count of all HIV tests provided, may exceed number of patients tested as a patient may receive >1 HIV test in the time period

Laboratory-based antigen/antibody tests
Point-of-care antigen/antibody tests
Laboratory-based viral load/nucleic acid tests
Point-of-care viral load/nucleic acid tests

14. HIV test prior calendar year

HIV Test	All Clients	Clients 18-39 years	Men who have sex with men (MSM) 18-39 years	Black MSM 18-39 years	Hispanic/Latino MSM 18-39 years
Laboratory-based antigen/antibody tests
Point-of-care antigen/antibody tests
Laboratory-based viral load/nucleic acid tests
Point-of-care viral load/nucleic acid tests

15. Does your clinic employ a PrEP navigator or anyone on staff whose responsibilities include helping clients obtain and continue with PrEP prescriptions?

    1. If yes, how many?

16. What financial assistance programs does your clinic provide (check all that apply, add additional to bottom of table)

Financial assistance program	Yes
Income-based sliding scale for clinical services
Assistance with enrollment in federal PrEP access programs (i.e., Ready Set PrEP)
Assistance with enrollment in drug manufacturer PrEP access programs
Other, please specify

17. What components are included in typical PrEP initiation and follow-up visits? (check all that apply, add additional to bottom of table)

    	PrEP Initiation Visit (Considering or starting PrEP)	PrEP Follow- up visit
    Screening for potential to benefit from PrEP to reduce the risk of acquiring HIV
    Counseling about all available PrEP options
    Providing printed patient materials about selected PrEP regimen
    Counseling about effect of adherence on PrEP efficacy
    Adherence support
    Assessment of insurance status
    Assistance with insurance enrollment if un- or under-insured
    Assistance with enrollment in PrEP access programs (e.g. Ready Set PrEP) if needed
    HIV testing
    Other STI testing (please specify)
    Other clinical testing (please specify)
    Other (please specify)

18. Does the clinic have a protocol for timing of PrEP follow up visits? If not, what is the range of time between the initial PrEP visit and the first follow up visit?

19. What is the process for scheduling follow-up visits? Is it clinic-initiated or patient-initiated?

20. Does your clinic have specific procedures for engaging (re-engaging) with patients who don’t return for PrEP follow-up visits?

    1. If yes, please describe

21. What PrEP adherence support does your clinic provide? (check all that apply, add additional to bottom of table)

PrEP adherence support	Yes
Printed patient materials
Links/information about online materials
Pill boxes
Electronic medication monitors
Automated medication reminders
Peer-to-peer adherence support
SMS/text reminders from clinic staff
Motivational interviewing-based intervention
App/smartphone based adherence support
Other (describe)

22. What types of educational materials does your clinic provide to clients? (check all that apply, add additional to bottom of table)

    Educational materials	Print	Online	None	Other, please specify
    Materials that address sexual health topics
    Materials that address sexually transmitted infections
    Materials that specifically address HIV
    Materials that specifically address PrEP
    Other (describe)

23. Are cabotegravir intramuscular injections for PrEP available at your clinic?

2. If yes, then please complete cabotegravir provider section

3. If no, then please complete cabotegravir non-provider section

Cabotegravir provider:

24. Does your clinic keep doses of cabotegravir available (in stock onsite)?

    1. If yes, how does your clinic order and maintain your supply? How many doses do you maintain in stock onsite?

       1. Do stock outs occur? If yes, how frequently?

       2. Do shortages occur? If yes, how frequently?

25. Do any patients pick up the drug at a pharmacy?

2. If yes, how is it prescribed? Does the clinic call/transmit the prescription to the pharmacy? Does the patient take a written prescription to the pharmacy?

3. How do patients pay for the drug if they don’t have prescription benefits?

4. If patients pick up the drug at the pharmacy, does the pharmacist administer the injection?

   1. If yes, does the pharmacist charge an injection fee?

26. For the initial prescription, what is the average time between cabotegravir prescription to administration of the cabotegravir dose?

2. If applicable, how does it vary by stocked drug in the clinic compared to picking up the drug at a pharmacy?

27. How is the patient billed for the injection? Is there a charge for the drug? A separate charge for the injection?

Cabotegravir non-provider:

28. Why does your clinic not currently provide cabotegravir?

29. If you are planning to provide it, when do you expect to make it available?