Natalie Danielle Crawford

Background: The United States (US) Southeast experiences a disproportionate burden of HIV, compounded by limited access to pre-exposure prophylaxis (PrEP) services due to systemic barriers, such as stigma, medical mistrust, and restrictive pharmacy policies. Collaborative practice agreements (CPAs) between pharmacists and clinicians represent a promising strategy to improve PrEP accessibility through pharmacy-based services. Objective: The Collaborative Agreement–based PrEP Using Pharmacies (CAP-UP) study aims to evaluate the development, implementation, and effectiveness of a CPA template and training resources to enhance pharmacy-based PrEP initiation and adherence in the Southeastern US. Methods: The CAP-UP study uses a hybrid type 1 effectiveness-implementation design guided by integrated implementation science frameworks. It includes three phases: (1) exploration, using online surveys and in-depth interviews to identify barriers and facilitators to CPA implementation; (2) preparation, developing and refining a CPA template and training resources; and (3) implementation, piloting the CPA template in 10 community pharmacies within high-HIV-prevalence neighborhoods. Results: The CAP-UP study was funded in October 2023 by the National Institutes of Health through the Center for AIDS Research (grant P30-AI050409-25S1) as an Ending the HIV Epidemic supplement. Recruitment launched in November 2023 and is actively ongoing, with 264 pharmacy staff having completed surveys as of January 2026. The study aims to recruit a total of 300 participants for surveys and conduct 68 in-depth interviews by February 2026. Conclusions: Expanding HIV prevention services through community pharmacies represents a practical and impactful strategy for addressing inequities in HIV prevention that advances health equity. By leveraging implementation science frameworks, our study explores a novel approach to integrating HIV prevention services in pharmacies located in areas with high HIV prevalence. Findings from this work will contribute to the evidence base needed to optimize pharmacy-based PrEP delivery and support the national goal of Ending the HIV Epidemic in the US.

Background: Human immunodeficiency virus (HIV) cases among people who inject drugs increased during the US overdose crisis. Although HIV pre-exposure prophylaxis (PrEP) decreases HIV acquisition, and medications for opioid use disorder (MOUD) reduce overdose deaths, uptake remains suboptimal. The CHORUS + study will test the efficacy of a comprehensive peer recovery coaching intervention to increase PrEP and MOUD initiation and adherence. Methods: This two-arm RCT will enroll 284 people who inject opioids (PWIO) and are negative for HIV from two sites. Participants randomized to the CHORUS + intervention will receive a study smartphone, motivational interviewing sessions, assistance connecting to PrEP and/or MOUD, and support to access resources addressing social needs such as employment and housing. We will also incorporate adapted ‘Life-Steps for PrEP’ modules to increase adherence. The control arm will receive information on local organizations with access to PrEP and MOUD. Participants will complete assessments at baseline, 1-, 3-, 6-, and 12-month visits. The primary outcome is adherence to HIV PrEP, assessed by tenofovir-diphosphate drug levels at 6-months post enrollment. Secondary outcomes include PrEP adherence assessed at 3- and 12-months, measured by drug levels (3-months), prescription refills, and self-report; and MOUD receipt at 3-, 6-, and 12-months, measured by prescription refills, self-report, and urine toxicology. The primary analysis will employ intent-to-treat logistic regression to assess differences in adherence between treatment arms, adjusting for stratification factors including site, race and sex assigned at birth. We will analyze secondary outcomes using similar methods. We will use multilevel growth curve modeling to evaluate changes in adherence over time by treatment group, incorporating random intercepts and slopes to account for individual trajectories. We will use exploratory multilevel structural equation modeling to assess mediators including HIV risk perception and PrEP/MOUD knowledge to understand pathways that may influence adherence. Discussion: The CHORUS + intervention integrates a novel, theory-based, peer-delivered, smartphone-supported approach to address HIV prevention and opioid use disorder, while tackling social and structural barriers to care. Findings will inform strategies for linking PWIO to rapid HIV prevention and substance use treatment. Trial registration: ClinicalTrials.gov number: NCT05769218.

Background: Despite advancements in HIV prevention, many Americans, particularly those from historically underserved communities (eg, racially and sexually minoritized individuals and people who use drugs), continue to face significant barriers to accessing crucial HIV prevention services such as HIV testing and pre-exposure prophylaxis. Integrating these services into community pharmacies is a viable yet underused solution to overcoming access-related challenges. However, few studies have used an implementation science approach to assess the implementation and effectiveness of such services in pharmacy settings. Objective: The Pharmacy-Based Access to HIV Prevention Services study aims to develop and evaluate a sustainable pharmacy-based model for increasing access to HIV testing and prevention services (eg, pre-exposure prophylaxis dispensing) in community pharmacy settings. Methods: We are using a hybrid type 1 effectiveness-implementation study design to evaluate the implementation and effectiveness of HIV testing and prevention services within community pharmacies, particularly among those that offer non–HIV-related screenings (eg, COVID-19, blood pressure, and cholesterol screening) and those that do not. We apply 3 well-established implementation science frameworks—the Exploration, Preparation, Implementation, Sustainment framework, the Consolidated Framework for Implementation Research, and the Systems Engineering Initiative for Patient Safety—to assess multilevel factors influencing the adoption of HIV prevention services in community pharmacy settings. This study consists of three phases: (1) a mixed methods exploration phase to identify barriers and facilitators of implementing HIV prevention services in community pharmacies, (2) a preparation phase to assess the effectiveness of two HIV training programs designed for pharmacy staff, and (3) an implementation and sustainment phase to evaluate the effectiveness and implementation of HIV prevention services in these settings. Results: The Pharmacy-Based Access to HIV Prevention Services study was funded in June 2023 by the National Institute of Mental Health (R01MH123470) and launched in September 2023. Recruitment and enrollment for the first phase, including data collection, are currently underway. We have exceeded our Phase 1 pharmacy staff survey target, with 310 participant surveys completed (goal: 300). Completion is anticipated by early 2026. Conclusions: Expanding access to HIV prevention services through community pharmacies is a promising and accessible approach to addressing social and health inequities in HIV, supporting the goal of Ending the HIV Epidemic in the United States. Implementation science, with its systematic frameworks, is essential to advancing this goal. Our study is among the first to use an implementation science approach to integrate HIV prevention services within community pharmacies in high-prevalence HIV areas. International Registered Report Identifier (IRRID): DERR1-10.2196/72283

Background: Despite the proven efficacy of preexposure prophylaxis (PrEP) in reducing the risk of HIV transmission, uptake remains suboptimal among populations with limited access and availability to PrEP-prescribing locations, particularly in the Southern United States. The accessibility of pharmacies positions them as a promising resource for expanding PrEP delivery and access and supporting uptake and adherence through HIV prevention programs to reduce geographic disparities. Objective: This study outlines a geospatial protocol to assess disparities in national PrEP availability. The aim of this study is to develop a protocol to identify, map, and describe the potential impact of expanding PrEP access and HIV prevention services to pharmacies as alternative PrEP delivery sites across the United States. We propose a reproducible mapping and analytic framework to visualize gaps and inform implementation strategies at the state and local levels. Methods: We create local and state maps to help visualize the impact of expanding access to HIV prevention services through pharmacies. We obtain data from three main data sources: (1) pharmacy locations from the National Council for Prescription Drug Programs (NCPDP), (2) PrEP-prescribing facility locations from the CDC’s National Prevention Information Network (NPIN), and (3) HIV case data per 100,000 persons from AIDSVu. We geocode pharmacies and PrEP-prescribing locations with Google application programming interfaces (APIs) via the ggmap package in R software. Maps are created by overlaying several different layers of general maps and aggregated data including base maps, choropleth maps, dot density maps. To quantitatively examine the potential impact of expanding HIV prevention services, we calculate a PrEP facility-to-need ratio (PfnR) as the total number of facilities (PrEP-prescribing or pharmacies) divided by the number of HIV cases per 100,000 persons. Fold-change estimates are computed to quantify the increase in service reach if pharmacies were incorporated into PrEP delivery. Results: Overall, maps depicted far greater availability of local pharmacies compared to PrEP-prescribing facilities. When considered in the context of HIV cases per 100,000 persons, pharmacies were more prevalent than PrEP-prescribing facilities in areas with higher HIV caseloads. Mean PfnRs for pharmacies ranged from 0.04 (Mississippi) to 1.3 (Alaska), while PrEP-prescribing facility PfnRs were as low as 0.0004 (Puerto Rico). Estimated fold-change increases ranged from 6.4 in Idaho to 120.3 in Puerto Rico, with the greatest increases in the Southern and Midwestern United States. Conclusions: This protocol provides a scalable and reproducible framework to assess PrEP service distribution and to identify areas which may benefit most from pharmacy integration. Our findings suggest that incorporating pharmacies into PrEP-delivery could substantially reduce geographic access barriers, especially in underserved regions. This work has critical implications for state and national policies focused on avenues to increase PrEP access and uptake and subsequently reduce HIV transmission in their regions.

Numerous states, including Georgia in April 2019, have advanced policies designed to increase availability of sterile syringes in pharmacies for people who inject drugs (PWID); however, the extent to which pharmacies are willing to sell syringes to PWID is unclear. We examine sterile syringes sales practices in Georgia pharmacies to PWID following a recent policy change and pharmacists' cited reasons for these practices. We conducted a telephone survey from October 2020 through May 2021 of one pharmacist (staff or manager) per pharmacy in a sample of Georgia retail pharmacies stratified by urbanicity. The 15-question survey queried respondents about the pharmacy's current practices regarding nonprescription sterile syringe sales and the respondents' perceptions of syringe sales and counseling practices to those purchasing syringes. Pharmacy and pharmacist demographics were collected and correlations between these characteristics were estimated using unadjusted logistic regression models. We obtained responses from 119 pharmacies (response rate = 34%). Most surveyed pharmacies (81%) reported that they did not sell syringes to patients without a prescription for nonmedical uses, including intravenous drug use. There were no differences in whether pharmacies were more or less likely to sell syringes by level of urbanicity, local poverty rate, local racial/ethnic composition, or pharmacy type (i.e., chain vs. independently owned). The most common reasons cited for not selling syringes were security concerns, that syringe sales encourage drug use, and corporate policy. Among pharmacists in pharmacies not currently selling syringes, only 54% of were aware of the state law change allowing sales of syringes without a medical reason. Despite an important policy change advancing harm reduction through sterile syringe access, availability of sterile syringes to PWID in Georgia pharmacies was likely still hampered by lack of dispensing by pharmacies. Implementation efforts following important policy changes-including building awareness of the new policy, encouraging support of harm reduction efforts, and continuing education around substance use disorders-are essential for achieving the intended outcomes of the policy.

BACKGROUND The United States (US) Southeast experiences a disproportionate burden of HIV, compounded by limited access to pre-exposure prophylaxis (PrEP) services due to systemic barriers such as stigma, medical mistrust, and restrictive pharmacy policies. Collaborative Practice Agreements (CPAs) between pharmacists and clinicians represent a promising strategy to improve PrEP accessibility through pharmacy-based services OBJECTIVE The Collaborative Agreement-based PrEP Using Pharmacies (CAP-UP) study aims to evaluate the development, implementation, and effectiveness of a CPA template and training resources to enhance pharmacy-based PrEP initiation and adherence in the Southeastern US. METHODS The CAP-UP study employs a hybrid type 1 effectiveness-implementation design guided by integrated implementation science frameworks. It includes three phases: (1) Exploration, using online surveys and in-depth interviews to identify barriers and facilitators to CPA implementation; (2) Preparation, developing and refining a CPA template and training resources; and (3) Implementation, piloting the CPA template in 10 community pharmacies within high-HIV-prevalence neighborhoods. RESULTS The CAP-UP study was funded in October 2023 by [the National Institutes of Health (NIH) through the Center for AIDS Research (CFAR) grant [P30-AI050409-25S1] as an Ending the HIV Epidemic Supplement. Recruitment launched in November 2023 and is actively ongoing, with 262 pharmacy staff having completed surveys as of April 2025. The study aims to recruit a total of 300 participants for surveys and conduct 68 in-depth interviews by June 2025. CONCLUSIONS Expanding HIV prevention services through community pharmacies represents a practical and impactful strategy for addressing inequities in HIV prevention that advances health equity. By leveraging implementation science frameworks, our study explores a novel approach to integrating HIV prevention services in pharmacies located in high-HIV-prevalence areas. Findings from this work will contribute to the evidence base needed to optimize pharmacy-based PrEP delivery and support the national goal of Ending the HIV Epidemic in the US

BACKGROUND Inequities in pre-exposure prophylaxis (PrEP) uptake span across populations and geographic regions. The accessibility of pharmacies positions them as a vital resource for expanding PrEP access and supporting uptake and adherence through HIV prevention programs. OBJECTIVE The aim of this study is to identify, map, and describe the potential impact of expanding PrEP access and HIV prevention services to pharmacies across the United States. METHODS We will create local and state maps to help visualize the impact of expanding access to HIV prevention services through pharmacies. Data will be obtained from three main data sources for pharmacy locations, PrEP-prescribing locations, and HIV cases per 100,000 persons. We will geocode pharmacies and PrEP-prescribing locations with Google application programming interfaces (APIs) via the ggmap package in R. Maps will be created by overlaying several different layers of general maps and aggregated data including base maps, choropleth maps, dot density maps. To quantitatively examine the potential impact of expanding HIV prevention services, we will calculate a PrEP facility-to-need ratio (PfnR) as the total number of facilities (PrEP-prescribing or pharmacies) divided by the number of HIV cases per 100,000 persons. RESULTS Overall, maps depicted far greater accessibility to local pharmacies compared to PrEP-prescribing facilities. When taken within the context of HIV cases per 100,000 persons, pharmacies were more prevalent than PrEP-prescribing facilities in areas with higher HIV caseloads. CONCLUSIONS This work has critical implications for state and national policies focused on avenues to increase PrEP access and uptake and subsequently reduce HIV transmission in their regions.