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.

Feasibility of reaching populations at high risk for HIV in community pharmacies.

BACKGROUND: Growing evidence has shown feasibility for HIV prevention service integration in pharmacies, including HIV testing and screening for pre-exposure prophylaxis (PrEP). Yet, further work is needed to determine whether pharmacies can effectively reach those at increased risk of HIV transmission. OBJECTIVES: We aimed to describe the HIV risk profiles and willingness to obtain HIV prevention services of a sample of pharmacy clients. METHODS: This was a cross-sectional pilot study aimed to develop a culturally appropriate pharmacy-based PrEP delivery model among Black men who have sex with men (MSM). Two pharmacies were recruited from low-income, underserved communities and participants were recruited within pharmacies for screener and social and behavioral surveys. Individuals were grouped by PrEP eligibility due to sexual risk, injection drug use risk, or both, and demographic and willingness measures were compared. RESULTS: Among 460 pharmacy clients, 81 (17.6%) would have been eligible for PrEP due to sex or injection drug use risk. Most were eligible due to sexual risk (58.0%), while a substantial proportion were eligible due to injection drug use (27.2%) or a combination of sexual and injection drug use risk behaviors (42.0%). Of these eligible, median age was 31 years (IQR=28,32) and most had ≥1 female (75.3%) or male (96.3%) partner in the past 6 months. There was high willingness to receive a free HIV test in a pharmacy (90.1%). Most were willing to screen for PrEP in a pharmacy (95.1%) despite these services not being available in the state where this study was performed. There were no differences in willingness to obtain pharmacy-based HIV prevention services across risk groups. CONCLUSION: This study shows that pharmacies in disadvantaged areas can serve a key role in preventing and decreasing the transmission of HIV by reaching populations with high HIV burden and providing HIV prevention services.

Comparing Sexual Network Mean Active Degree Measurement Metrics Among Men Who Have Sex With Men.

BACKGROUND: Mean active degree is an important proxy measure of cross-sectional network connectivity commonly used in HIV/sexually transmitted infection epidemiology research. No current studies have compared measurement methods of mean degree using a cross-sectional study design for men who have sex with men (MSM) in the United States. We compared mean degree estimates based on reported ongoing main and casual sexual partnerships (current method) against dates of first and last sex (retrospective method). METHODS: We used data from ARTnet, a cross-sectional survey of MSM in the United States (2017-2019). ARTnet collected data on the number and types of sexual partners in the past year, limited to the 5 most recent partners (data truncation). We quantified partnerships for months 0 to 12 before the survey date (retrospective method) and compared that with ongoing partnerships on the day of survey (current method). We used linear regression to understand the impact of truncated partnership data on mean degree estimation. RESULTS: The retrospective method yielded similar degree estimates to the current for months proximate to the day of survey. The retrospective method mean degree systematically decreased as the month increased from 0 to 12 months before survey date. This was driven by data truncation: among participants with >5 partners in the past year compared with those with ≤5, the average change in main partnership degree between 12 and 0 months before survey date was -0.05 (95% confidence interval, -0.08 to -0.03) after adjusting for race/ethnicity, age, and education. The adjusted average change in casual partnership degree was -0.40 (95% confidence interval, -0.45 to -0.35). CONCLUSIONS: The retrospective method underestimates mean degree for MSM in surveys with truncated partnership data, especially for casual partnerships. The current method is less prone to bias from partner truncation when the target population has high rate of partners per year.

Projected HIV and Bacterial Sexually Transmitted Infection Incidence Following COVID-19-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). It is unknown what combined impact reductions in sexual activity and interruptions in HIV/STI services will have on HIV/STI epidemic trajectories. METHODS: We adapted a model of HIV, gonorrhea, and chlamydia for a population of approximately 103 000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-19-related sexual distancing and service interruption within 4 service categories (HIV screening, preexposure prophylaxis, antiretroviral therapy, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM, -227 cases), but have net protective effect for STIs (-23 800 cases). If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57 500 STI cases. CONCLUSIONS: Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID-19 pandemic on the HIV/STI epidemic.

Gaps in Sexually Transmitted Infection Screening Among Men who Have Sex with Men in Pre-exposure Prophylaxis (PrEP) Care in the United States.

BACKGROUND: The US Centers for Disease Control and Prevention (CDC) recommends comprehensive sexually transmitted infection (STI) screening every 3-6 months for men who have sex with men (MSM) using human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). The gaps between these recommendations and clinical practice by region have not been quantified. METHODS: We used survey data collected from the internet-based ARTnet study between 2017 and 2019 on STI screening among MSM across the United States, stratified by current, prior, and never PrEP use. Poisson regression models with robust error variance were used to model factors, including residence in the Southeast, associated with consistent ("always" or "sometimes") exposure site-specific STI screening during PrEP care. RESULTS: Of 3259 HIV-negative MSM, 19% were currently using PrEP, 6% had used PrEP in the past, and 75% had never used PrEP. Among ever PrEP users, 87%, 78%, 57%, and 64% reported consistent screening for STIs by blood sample, urine sample or urethral swab, rectal swab, or pharyngeal swab, respectively, during PrEP care. Compared to PrEP users in all other regions, PrEP users in the Southeast were significantly less likely to be consistently screened for urogenital (adjusted prevalence ratio [aPR], 0.86; 95% confidence interval [CI], .76-.98) and rectal STIs (aPR, 0.76; 95% CI, .62-.93) during PrEP care. CONCLUSIONS: Substantial gaps exist between CDC recommendations for STI screening during PrEP care and current clinical practice, particularly for rectal and pharyngeal exposure sites that can harbor asymptomatic infections and for MSM in Southeast states where the STI burden is substantial.

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.

Prevalence and Correlates of COVID-19 Vaccine Information on Family Medicine Practices' Websites in the United States: Cross-sectional Website Content Analysis.

BACKGROUND: Primary care providers are regarded as trustworthy sources of information about COVID-19 vaccines. Although primary care practices often provide information about common medical and public health topics on their practice websites, little is known about whether they also provide information about COVID-19 vaccines on their practice websites. OBJECTIVE: This study aimed to investigate the prevalence and correlates of COVID-19 vaccine information on family medicine practices' website home pages in the United States. METHODS: We used the Centers for Medicare and Medicaid National Provider Identifier records to create a sampling frame of all family medicine providers based in the United States, from which we constructed a nationally representative random sample of 964 family medicine providers. Between September 20 and October 8, 2021, we manually examined the practice websites of these providers and extracted data on the availability of COVID-19 vaccine information, and we implemented a 10% cross-review quality control measure to resolve discordances in data abstraction. We estimated the prevalence of COVID-19 vaccine information on practice websites and website home pages and used Poisson regression with robust error variances to estimate crude and adjusted prevalence ratios for correlates of COVID-19 vaccine information, including practice size, practice region, university affiliation, and presence of information about seasonal influenza vaccines. Additionally, we performed sensitivity analyses to account for multiple comparisons. RESULTS: Of the 964 included family medicine practices, most (n=509, 52.8%) had ≥10 distinct locations, were unaffiliated with a university (n=838, 87.2%), and mentioned seasonal influenza vaccines on their websites (n=540, 56.1%). In total, 550 (57.1%) practices mentioned COVID-19 vaccines on their practices' website home page, specifically, and 726 (75.3%) mentioned COVID-19 vaccines anywhere on their practice website. As practice size increased, the likelihood of finding COVID-19 vaccine information on the home page increased (n=66, 27.7% among single-location practices, n=114, 52.5% among practices with 2-9 locations, n=66, 56.4% among practices with 10-19 locations, and n=304, 77.6% among practices with 20 or more locations, P<.001 for trend). Compared to clinics in the Northeast, those in the West and Midwest United States had a similar prevalence of COVID-19 vaccine information on website home pages, but clinics in the south had a lower prevalence (adjusted prevalence ratio 0.8, 95% CI 0.7 to 1.0; P=.02). Our results were largely unchanged in sensitivity analyses accounting for multiple comparisons. CONCLUSIONS: Given the ongoing COVID-19 pandemic, primary care practitioners who promote and provide vaccines should strongly consider utilizing their existing practice websites to share COVID-19 vaccine information. These existing platforms have the potential to serve as an extension of providers' influence on established and prospective patients who search the internet for information about COVID-19 vaccines.

Projected HIV and Bacterial STI Incidence Following COVID-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact the transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). Studies have already documented reductions in sexual activity ("sexual distancing") and interruptions in HIV/STI services, but it is unknown what combined impact these two forces will have on HIV/STI epidemic trajectories. METHODS: We adapted a network-based model of co-circulating HIV, gonorrhea, and chlamydia for a population of approximately 103,000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-related sexual distancing in casual and one-time partnership networks and service interruption within four service categories (HIV screening, HIV PrEP, HIV ART, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM: -227 cases), but have net protective effect for STIs (-23,800 cases). Greater relative reductions and longer durations of service interruption would increase HIV and STI incidence, while greater relative reductions and longer durations of sexual distancing would decrease incidence of both. If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57,500 STI cases. CONCLUSIONS: The counterbalancing impact of sexual distancing and clinical service interruption depends on the infection and the extent and durability of these COVID-related changes. If sexual behavior rebounds while service interruption persists, we project an excess of hundreds of HIV cases and thousands of STI cases just among Atlanta MSM over the next 5 years. Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID pandemic on the HIV/STI epidemic.

Calculating indirect costs from international PEPFAR implementing partners.

BACKGROUND: UNAIDS estimates global HIV investment needs in low- and middle-income countries (LMICs) at $26 billion per year in 2020. Yet international financing for HIV programs has stagnated amidst despite the increasing number of people requiring and accessing treatment. Despite increased efficiencies in HIV service delivery, evaluating programs for greater efficiencies remains necessary. While HIV budgets have been under scrutiny in recent years, indirect costs have not been quantified for any major global HIV program, but may constitute an additional avenue to identify program efficiencies. This analysis presents a method for estimating indirect costs in the President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: Utilizing PEPFAR country operational plan (COP) funding data from 2007 to 2016 for international organizations (IOs) and universities and standard regulatory cost bases, we calculated modified total direct costs on which indirect cost rates may be applied by partner and funding agency. We then apply a series of plausible indirect cost rates (10%-36.28%) to develop a range for total indirect costs that have accrued over the period. FINDINGS: Of $37.01 billion in total COP funding between 2007 and 2016, $22.24 billion (60.08%) was identifiably allocated to IOs ($17.95B) and universities ($4.29B). After excluding funding for sub-awards ($1.92B) and other expenses ($3.89B) to which indirect rates cannot be applied, $16.44B remained in combined direct and indirect costs. From this, we estimate that between $1.85B (8.30% of total international partner funding) and $4.34B (19.51%) has been spent on indirect costs from 2007-2016, including $157-$369 million in 2016. INTERPRETATION: To our knowledge, this is the first analysis to quantify the indirect costs of major implementing partners of a global HIV funder. However, lack of transparency in the indirect cost rates of non-University international partners creates an opaque layer of programmatic costs. Given the current funding environment and evolution of HIV programming in PEPFAR countries, the findings motivate a re-examination of the current policies and the return on investment in indirect cost recovery across the PEPFAR program.