Integrating and Disseminating Pre-Exposure Prophylaxis (PrEP) Screening and Dispensing for Black Men Who Have Sex With Men in Atlanta, Georgia: Protocol for Community Pharmacies

Background Black men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United States. Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 99% among men who have sex with men, yet profound racial disparities in the uptake of PrEP persist. Low PrEP uptake in BMSM is driven by poor access to PrEP, including inconvenient locations of PrEP-prescribing physicians, distrust of physicians, and stigma, which limit communication about PrEP and its side effects. Previous work indicates that offering HIV prevention services in pharmacies located in low-income, underserved neighborhoods is feasible and can reduce stigma because pharmacies offer a host of less stigmatized health services (eg, vaccinations). We present a protocol for a pharmacy PrEP model that seeks to address challenges and barriers to pharmacy-based PrEP specifically for BMSM. Objective We aim to develop a sustainable pharmacy PrEP delivery model for BMSM that can be implemented to increase PrEP access in low-income, underserved neighborhoods. Methods This study design is a pilot intervention to test a pharmacy PrEP delivery model among pharmacy staff and BMSM. We will examine the PrEP delivery model’s feasibility, acceptability, and safety and gather early evidence of its impact and cost with respect to PrEP uptake. A mixed-methods approach will be performed, including three study phases: (1) a completed formative phase with qualitative interviews from key stakeholders; (2) a completed transitional pilot phase to assess customer eligibility and willingness to receive PrEP in pharmacies during COVID-19; and (3) a planned pilot intervention phase which will test the delivery model in 2 Atlanta pharmacies in low-income, underserved neighborhoods. Results Data from the formative phase showed strong support of pharmacy-based PrEP delivery among BMSM, pharmacists, and pharmacy staff. Important factors were identified to facilitate the implementation of PrEP screening and dissemination in pharmacies. During the transitional pilot phase, we identified 81 individuals who would have been eligible for the pilot phase. Conclusions Pharmacies have proven to be a feasible source for offering PrEP for White men who have sex with men but have failed to reach the most at-risk, vulnerable population (ie, BMSM). Increasing PrEP access and uptake will reduce HIV incidence and racial inequities in HIV. Translational studies are required to build further evidence and scale pharmacy-based PrEP services specifically for populations that are disconnected from HIV prevention resources. International Registered Report Identifier (IRRID) DERR1-10.2196/35590

1 R34 MH119007-01 3 BSPH CRAWFORD, N PUBLIC HEALTH RELEVANCE: The proposed research will develop a culturally appropriate pharmacy PrEP delivery model and examine its feasibility, acceptability, and safety for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.

CRITIQUE 1
Significance: 1 Investigator(s): 1 Innovation: 2 Approach: 2 Environment: 1 Overall Impact: The proposed pilot study aims to determine the capacity of pharmacies in African American neighborhoods to screen, counsel and provide PrEP to Black men who have sex with men (BMSM). The study includes 3 phases -formative research with pharmacists, intervention development, and intervention assessment. Their approach is informed by Systems Engineering Initiative for Patient Safety (SEIPS) which is a multi-level approach to assessing feasibility, acceptability and safety of patient services. This approach is integrated at each phase of the study and involves qualitative, quantitative, cost, and observational data collection methods. This outstanding application has numerous strengths. Pharmacies are well positioned to provide preventive services to diverse populations. In most urban communities (even poor ones) they are available, focused on customer service, and interested in expanding the types of services they provide. Studies in other low-income areas with more controversial issues (e.g., syringe access) have found pharmacies to be appropriate sites for expanded services. The significance of the project is high. BMSM are at elevated risk for HIV transmission, yet PrEP uptake rate remain low in the population (<20%). The use of pharmacies could be one, sustainable way for improving PrEP uptake for this high need population. Further, the study is innovative in its use of the physical space of pharmacies, its application of self-testing for HIV and STIs in this setting, and its use of existing relationships with pharmacies to enhance uptake of PrEP. The investigative team is excellent. They possess expertise and experience in all key areas of the proposed study and have conducted preliminary studies that indicate that their approach is acceptable to BMSM. The overall approach is rigorous for a pilot study. They make use of a CAB to inform all aspects of the study, provide incentives to pharmacists and technicians to complete training, plan to collect both cost and observation data on workflows in the intervention, and have an iterative approach to intervention deployment which should allow them to identify potential barriers to deployment of the intervention. Only minor weaknesses were noted. I think the CAB would be strengthened by the inclusion on 1 or 2 BMSM stakeholders and the selection criteria use by technicians to offer PrEP screening is unclear. However, both of these concerns are easily addressed within the parameters of the proposed research. My overall enthusiasm for this novel, high significance intervention development proposal is very high and greatly outweighs my minor concerns.

Significance:
Strengths  BMSM are among the populations at highest risk for HIV transmission. Efforts to improve enrollment in PrEP are needed for this population.  Making use of existing commercial enterprises to enhance HIV prevention saves resources and may improve sustainability should interventions prove to be effective.    Preliminary studies indicate that their approach is acceptable to BMSM.

Weaknesses
 The use of a CAB is appropriate.
 The approach appears to address potential barriers to pharmacies participating in such a program by providing training and incentives to staff.

Weaknesses
 It was not clear if the CAB included BMSM from the community. If not, a few should be added to the CAB. Overall Impact: This R34 application from a junior investigator seeks to develop and pilot a pharmacybased intervention to increase PrEP access among black MSM (BMSM). The premise is that there are seemingly greater barriers to accessing PrEP among BMSM, and pharmacies represent a more viable option to delivering PrEP than traditional primary care practices. HIV rates are greater among BMSM compared to white MSM, and PrEP uptake is lower. Therefore, increasing uptake rates among BMSM is a priority. The highest risk group for HIV, however, is young BMSM. There is no mention of targeting this intervention for this group, which would dramatically increase the significance of the proposed intervention. The PI does not have a track record of independent funding, and the roles of the Co-I's are not clearly defined in their biosketches. The delivery mechanism (pharmacies) for PrEP is innovative, but the broad focus on all BMSM, versus young BMSM somewhat limits the innovation. Although it is understood that the protocol will be developed and refined based on the qualitative interviews and feedback from participants, there are fundamental questions that if not addressed in the application, call into question the feasibility of the intervention. First, it is not clear who will be approached and how they will be approached. Will all minority men at the pharmacy be asked to participate? How will it be determined that they are MSM? Also, use of pharmacy techs is certainly ideal from a resources and portability standpoint, there are a host of potential issues (comfort level in approaching participants who may be neighbors/friends, being coerced by employer into participating, etc) that were not addressed. The majority of pharmacy staff interviews should be conducted with the techs, not the pharmacists, since they will primarily be in contact with the participants. The environment is excellent.

Significance:
Strengths  HIV rates among black MSM (BMSM) higher than white MSM  PrEP uptake rates among BMSM lower than white MSM Weaknesses  Why is this taking place in a pharmacy? The pharmacist is not involved, and the only requirement is that there is a private room. Did not make the case for a pharmacy vs another, community-based venue.
 Not targeting the highest risk group -young minority MSM. This severely limits the significance of the proposed intervention.  One of the issues with accessing PrEP through PCP's is the potential wait time for an appointment. Are there plans in place to mitigate wait times within this particular intervention? What if they only want to see their own physician? This aspect was glossed over.  Finally, the proposal does not read well. As a result, it is hard to follow.

Budget and Period of Support:
Recommend as Requested:

CRITIQUE 3
Significance: 3 Investigator(s): 1 Innovation: 3 Approach: 3 Environment: 1 Overall Impact: This application, submitted by a new investigator proposes to develop a new approach to pharmacy based PrEP distribution for Black Men who have Sex with Men (BMSM), one of the most 1 R34 MH119007-01 9 BSPH CRAWFORD, N vulnerable groups for HIV. The application is very well prepared and the applicant has put together an excellent and comprehensive team of investigators and advisors. The study proposes pharmacist initiated screening and self-testing, and immediate linkage to a prescriber, who will provide a 7 day script. A follow-up appointment will be required to extend the script. The intervention proposed contains many of the issues identified in the proposal about why PrEP use rates are so low in this population, and why they aren't sustained after trials. While I realize that regulations constrain the intervention, it's not clear that the long-term goal of developing a new pharmacy model that does not rely on nurse practitioners can be achieved.

Significance:
Strengths  PrEP is underutilized and initiated late in this key population for the HIV epidemic.
 HIV among BMSM is clustered in poor neighborhoods with low access to HIV care facilities  Regulatory restrictions inhibit more accessible delivery models, such as community pharmacies, which are ubiquitous in poorer neighborhoods.  Intervention Development well described, and intervention to be developed closely with participation across a wide range of stakeholders on the investigative team and the advisory board.

Weaknesses
 Physician on-call or nurse practitioner still required. Not sure if intervention proposed is 1) very different from others; and 2) sustainable in this environment for scale-up.

Environment:
Strengths  Emory has excellent resources and the applicant and her team are well placed to take advantage of them.
 Emory has strong links to the communities involved and the key populations.

 None Noted
Study Timeline:

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections  Careful description of processes to maintain confidentiality.

Inclusion of Women, Minorities and Children:
 Sex/Gender: Distribution justified scientifically

Budget and Period of Support:
Recommend as Requested: Footnotes for 1 R34 MH119007-01; PI Name: CRAWFORD, NATALIE D + Derived from the range of percentile values calculated for the study section that reviewed this application.

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE, OR REVIEWERS' WRITTEN CRITIQUES, ON THE FOLLOWING ISSUES
NIH has modified its policy regarding the receipt of resubmissions (amended applications). See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.html. The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10. The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score. Some applications also receive a percentile Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant investigators and institutional officials must not communicate directly with study section members about an application before or after the review. Failure to observe this policy will create a serious breach of integrity in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.html, including removal of the application from immediate review. Consultants are required to absent themselves from the room during the review of any application if their presence would constitute or appear to constitute a conflict of interest.