Implementation Science of Integrating Pre-Exposure Prophylaxis in Pharmacist-Led Services in the United States.

BACKGROUND: Racial inequities in HIV in the United States (US) are pervasive. Pre-exposure prophylaxis (PrEP) is one of the most effective yet underutilized HIV prevention strategies, and stark inequities in PrEP uptake exist. Lack of access to PrEP clinics is a major barrier to access that could be overcome by integrating pharmacists into the provision of PrEP services including prescribing and dispensing. METHODS: A number of reviews have shown promise in folding pharmacies into the expansion of PrEP services, but this review extends those by examining the implementation science evidence of pharmacist-led PrEP services in the US. We reviewed literature over the past five years of the implementation science of pharmacist PrEP services (2018-2023) and present seminal findings in this area. RESULTS: Only two studies are anchored within an implementation science framework despite all studies assessing common implementation science constructs. Overwhelming evidence supports feasibility and adoption of PrEP services in pharmacies yet gaps in workflow integration, scalability and sustainability exist. CONCLUSION: Continuing to build the implementation science evidence of pharmacy-based PrEP services is critical to standardize our measures across varying contexts and inform policy efforts that support pharmacy-based PrEP services.

Sexual and Gender Minority Individuals' Interest in Sexual Health Services at Collective Sex Venues in New York City.

Sexual and gender minority individuals who attend collective sex venues (CSVs; establishments where people can have sex in groups or the presence of others) are at elevated risk for HIV and STIs. On-site sexual health interventions have been attempted at CSVs, but attendees' interest in receiving such services is under-investigated. This paper presents results from a 2020 online cross-sectional survey completed by 342 sexual and gender minority individuals who attended CSVs in New York City. Interest in services such as on-site testing for STIs, testing vans near CSVs, and informational referrals was overall high, particularly among younger participants. Among participants who reported being HIV negative, those of younger age and those who were not using PrEP reported being more likely to take an HIV test if it would be offered at CSVs. In open-text survey responses, participants expressed interest in CSVs providing free prevention services such as HIV/STI testing, PEP, PrEP, and STI medications or vaccination, as well as in ways to improve norms surrounding condom use and consent at these venues. Some participants expressed barriers to on-site services such as privacy concerns, preexisting access to health services, an emphasis on personal responsibility, and negative reactions to the presence of service providers. However, some participants also felt that these services could be delivered in a positive, acceptable, and non-judgmental way, especially by involving CSV organizers and attendees in their implementation. Findings from this study can inform future initiatives to develop sexual health interventions at CSVs.

Comparing open-ended question methods to vignette methods to explore willingness to obtain pre-exposure prophylaxis access in pharmacies among black men who have sex with men.

Black men who have sex with men (BMSM) are at higher risk of HIV transmission than any other group; however, their uptake of the highly effective HIV prevention medication, pre-exposure prophylaxis (PrEP), is low. In collaboration with a communitybased organization in Atlanta, Georgia, we explored ten HIV-negative BMSM's willingness to obtain PrEP in pharmacies using standard open-ended and vignette qualitative methods. Three overarching themes were identified: privacy, patient-pharmacist interactions, and HIV/STI screening. While open-ended questions allowed participants to provide broad answers on their willingness to receive prevention services at a pharmacy, the vignette drew out specific responses to facilitate in-pharmacy PrEP delivery. Using both openended questions and vignette data collection strategies, BMSM reported high willingness to screen for and uptake PrEP in pharmacies. However, the vignette method allowed for greater depth. Open-ended questions elicited responses that highlighted general barriers and facilitators of PrEP dispensing in pharmacies. However, the vignette allowed participants to customize a plan of action that would best fit their needs. Vignette methods are underutilized in HIV research and may be helpful in supplementing standard open-ended interview questions to uncovering unknown challenges about health behaviors and obtain more robust data on highly sensitive research topics in HIV research.

Examining pharmacies' ability to increase pre-exposure prophylaxis access for black men who have sex with men in the United States.

BACKGROUND: Pre-exposure prophylaxis (PrEP) has not effectively reached black men who have sex with men (BMSM). Using innovative, nontraditional health care settings-such as community pharmacies-may improve PrEP uptake among BMSM. OBJECTIVE: To examine correlates of patient willingness to be screened for PrEP (via human immunodeficiency virus [HIV] testing and risk assessment) in pharmacies among BMSM in the United States. METHODS: Data from the 2020 American Men's Internet Survey were analyzed. Using a modified Poisson regression method with robust variance estimates, we examined differences in willingness to screen for PrEP in pharmacies among BMSM. A 95% confidence interval (95% CI) was calculated for each estimated prevalence ratio (PR). RESULTS: Of 826 respondents, 637 (77%) were willing to be screened for PrEP in pharmacies. Having a high school degree (PR 0.76 [95% CI 0.62-0.95]), willingness to use PrEP (1.70 [1.41-2.05]), and comfort speaking with pharmacy staff about PrEP (2.5 [1.86-3.51]) were significantly associated with willingness to screen for PrEP in a pharmacy setting. Importantly, there were no observed differences in willingness by age, employment status, annual household income, or insurance status. CONCLUSION: Pharmacy-based PrEP access may be an effective strategy to end inequities in HIV, given that our results indicate that most BMSM are willing to be screened for PrEP in pharmacies. Future studies should examine whether willingness to use pharmacy-based HIV prevention services is associated with subsequent uptake of these services among BMSM.

Attitudes Toward Peer-Delivered Sexual-Health Services Among New York City Sexual and Gender Minority Individuals Who Have Sex with Men and Attend Collective Sex Venues.

Collective sex venues such as sex clubs are strategic sites to promote sexual health among sexual and gender minority individuals. We present qualitative findings from a multiple-method study on the acceptability of sexual-health services at collective sex venues in New York City (NYC) among attendees who identified as men, transgender, or gender non-conforming. In a survey used for sample selection (n = 342), most respondents (82.7%) agreed that "having outreach workers at sex venues is a good thing." Interviewees (n = 30) appreciated how on-site services could promote sexual health in their community. They felt peer workers should be familiar with collective sex venues and share demographic characteristics with attendees. Some participants felt workers should keep some boundaries from attendees, while others felt they could be fully integrated in the environment, suggesting that either peer outreach or popular-opinion leader types of interventions could be feasible.

Willingness to Attend Sex Venues in the Context of the COVID-19 Pandemic in New York City: Results from an Online Survey with Sexual and Gender Minority Individuals.

Collective sex venues (places where people have sex in groups or in the presence of others, such as bathhouses or sex clubs) are locations where SARS-CoV-2 transmission is likely to occur. We conducted an online survey to examine the impact of the COVID-19 pandemic among 342 sexual and gender minority (SGM) individuals who had attended collective sex venues (CSV) in New York City (NYC) in the prior year. Almost 1 in 10 (9.9%) participants reported having received a positive test for SARS-CoV-2 infection or antibodies. Although a minority (27.5%) of participants reported being comfortable attending a CSV during the COVID-19 pandemic, multivariable ordinal logistic regression found that willingness was higher among participants who had taken the survey later in the pandemic (aOR = 2.90, CI95% 1.90 to 4.43), who attended CSV at higher frequencies (aOR = 1.94, CI95% 1.26 to 2.99), who used substances at CSV (aOR = 1.98, CI95% 1.22 to 3.23), and who had tested positive for SARS-CoV-2 infection or antibodies (aOR = 2.27, CI95% 1.17 to 4.39). In open survey answers, participants described reasons for or against attending CSV during the pandemic, as well as risk reduction strategies that would make them more comfortable attending (e.g., screening for test results, doing temperature checks, holding outdoor events, or restricting events to lower risk sexual practices). SGM individuals who attend CSV might be at increased risk for COVID-19. Public health officials should provide CSV organizers and attendees with guidelines on how to prevent or minimize transmission risk in the context of pandemics such as COVID-19.

Examination of HIV Preexposure Prophylaxis Need, Availability, and Potential Pharmacy Integration in the Southeastern US.

Importance: Daily preexposure prophylaxis (PrEP) use can prevent up to 99% of HIV infections; however, PrEP uptake is low due to poor access to PrEP-prescribing locations for populations at increased risk for HIV, especially in the southeastern US. Pharmacies are a feasible option to increase PrEP access, but little is known about how they could complement current PrEP-prescribing locations. Objective: To examine geographic distributions of current PrEP-prescribing locations compared with pharmacies and the facility to need ratios (PFNRs) according to HIV risk in the Southeast and describe the potential reach of pharmacies to expand PrEP access. Design, Setting, and Participants: Data for this cross-sectional study of PrEP-prescribing locations and pharmacies were compiled from January 1 to December 31, 2021. States or specific counties in the Southeast included in this study were jurisdictions identified as high-priority areas for the Ending the HIV Epidemic in the US (EHE) initiative. Exposure: Expansion of HIV prevention services to pharmacies. Main Outcomes and Measures: Choropleth maps of 5-year HIV risk per 100 000 persons were developed for EHE jurisdictions in the southeastern US. PrEP-prescribing locations (obtained from a national database of PrEP prescribers) and pharmacies (obtained from state pharmacy boards) were overlayed on HIV risk maps. The PFNRs by state were calculated as number of facilities (PrEP-prescribing locations or pharmacies) divided by 5-year HIV risk per 100 000 persons. Lower PFNRs indicated lower geographic availability of locations to meet the needs of the population at risk for HIV. The PFNRs for current PrEP-prescribing locations vs pharmacies were compared. Results: Among the 2 southeastern states and 13 counties in 4 southeastern states included, PrEP-prescribing locations were unequally distributed across EHE areas, with substantially fewer in areas at high risk for HIV. Pharmacies were evenly dispersed across areas regardless of HIV risk. The mean PFNR across all states for current PrEP-prescribing locations was 0.008 (median, 0.000 [IQR, 0.000-0.003]); for pharmacies, it was 0.7 (median, 0.3 [IQR, 0.01-0.1]). The PFNRs were at least 20.3 times higher for pharmacies compared with PrEP-prescribing locations. States with the greatest potential increase in PFNRs with expansion to pharmacies included Kentucky, South Carolina, and Tennessee. Conclusions and Relevance: The findings of this cross-sectional study suggest that expanding HIV prevention services to pharmacies in EHE areas in the Southeast could significantly increase capacity to reach individuals at increased risk of HIV transmission. Legislation aimed at allowing pharmacists to prescribe PrEP and provide HIV prevention services may be an important next step in ending the HIV epidemic.

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.