Form 0920-22GA Aims 1&2 Clinic Assessment (every 6 months)

Form Approved

OMB No. 0920-New

Expiration Date: XX/XX/XXXX

Expanding PrEP in Communities of Color (EPICC+)

Attachment 4s

Aim 1&2 Clinic Assessment Every Six Months

Public reporting burden of this collection of information is estimated to average 90 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 Every 6 months

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

Instructions: Clinic staff should complete this assessment every 6 months during data collection starting 6 months after the baseline clinic assessment is completed.

Clinic Information

1. Name of clinic

2. Address

3. Days and hours of operation

4. 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)

5. Number of clinical providers¹

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

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

   1. If yes, does it dispense PrEP medications?

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

PrEP Prescriptions²

9. PrEP prescriptions last 6 months

PrEP Regimen

All Clients

Clients 18-39 years

Men who have sex with men

Black MSM 18-39 years

Hispanic/Latino MSM 18-39 years

¹ Persons with capacity to prescribe medications

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

			(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

Clinical Services

10. HIV tests³ last 6 months (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

11. 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?

12. 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

13. 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)

14. 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?

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

16. 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

17. 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)

18. 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)

19. 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:

20. 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?

21. 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?

22. 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?

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

Cabotegravir non-provider:

24. Why does your clinic not currently provide cabotegravir?

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