• PI: Sarah K. Calabrese, PhD, George Washington University
• Mentors: April Pettit, MD, MPH and Elvin Geng, MD, MPH

Abstract

Ending HIV in Washington, DC, requires people of both serostatuses to be aware of, access, and adhere to the highly effective biomedical treatment and prevention options that exist, including antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). The DC Ends HIV plan recognizes these needs and stigma as a key barrier to addressing them. An HIV status-neutral educational intervention promoting both
Undetectable=Untransmittable (U=U) and pre-exposure prophylaxis (PrEP) and simultaneously engaging people of both serostatuses could maximize reach and impact while mitigating stigma. Guided by an implementation research logic model and the information-motivation-behavioral skills theory of behavior change, we propose a collaboration between academic researchers at George Washington University and implementing and community partners in a DC community healthcare setting (Whitman-Walker [WW]) to develop and evaluate English and Spanish versions of a 5-minute, HIV status-neutral web-based educational video intervention to reduce stigma and promote ART and PrEP, and to develop a plan for implementation at WW. We will engage WW health administrators and clinicians in key informant interviews (n = 6) and sexual and gender minority patients in focus groups (6 groups, total n = 24-48) to elicit initial video input and develop a plan for future video implementation at WW. The video will be further refined through an iterative, human-centered design process whereby the focus group patients provide feedback at four stages of video development. Subsequently, we will evaluate the acceptability and perceived impact of English and Spanish versions of the video using an online survey with 120-240 WW sexual and gender minority patients, ensuring representation from gender minority, Spanish-speaking, and Black patients. The study will yield a status-neutral video intervention, intervention acceptability data, and a tailored implementation plan. Study results will also provide pilot data for an NIH R34 grant application to conduct an implementation study building on this work. Ultimately, development of an HIV status-neutral web-based educational video about U=U and PrEP will provide a brief, inexpensive, easily scalable intervention to advance the priorities of the DC Ends HIV plan and the broader Ending the HIV Epidemic in the US initiative.

• PI: Theo Sandfort, PhD, Columbia University, NYS Psychiatric Institute
• Mentor: Byron Powell, PhD

Abstract

Transgender women (TGW), and especially those with an ethnic and racial minority status, are in critical need of tailored and enhanced HIV testing and prevention efforts. TGW are disparately impacted by HIV but are less likely to get tested for HIV. HIV testing is a critical entry point for the uptake of HIV prevention (e.g., PrEP) and HIV care and should also be leveraged to provide a link to other critical social support services, such as mental health and substance use treatment, which, if unaddressed might interfere with the uptake of HIV prevention and care practices. The proposed project aims to address these needs by developing a blueprint for the implementation of an evidence-based intervention, the Online HIV Self-Test Giveaway (OHTG), adapted to the needs of TGW in NYC. We aim to develop a blueprint for the OHTG adapted for TGW employing the Implementation Mapping approach and informed by Implementation Science guidelines. Implementation Mapping offers an ideal framework to guide the development of this process by helping to systematically map out relevant determinants, performance objectives, and outcomes from multiple ecologic levels, including that of the adapter, the implementer, and the broader environment, that structurally support the implementation strategy. Implementation Mapping includes the following four steps, that we will implement iteratively: (1) identify program adopters and implementers and conducting an implementation needs assessment; (2) specify adoption and implementation outcomes, performance objectives, and determinants, and creating matrices of change; (3) choose theoretical methods (mechanisms of change) and selecting or designing implementation strategies; and (4) produce and test implementation protocols and materials. The fifth step, the evaluation of the implementation outcomes will follow the completion of this one-year planning activity. However, we will design this evaluation as a final step in the Implementation Mapping process. Using Implementation Mapping will allow us to operationalize adaptation as a process of thoughtful and deliberate alteration of the design and delivery of OHTG with the goal to improve fit of the campaign with the needs, circumstances, and culture of TGW, as informed by the community, and with that, strengthen its effectiveness.

• PI: Jessica Corcoran, PhD, CRNP, CPNP-PC, University of Alabama at Birmingham, School of Nursing
• Mentor: Aima Ahonkhai, MD, MPH

Abstract

Black adolescents and young adults bear a disproportionate burden of both HIV and STI acquisitions, especially in the South. Increased HIV and STI screening, sexual health discussions, and uptake of PrEP is vital to improving overall sexual health for this population, but PrEP uptake and HIV and STI screening in the South is currently inadequate. We propose to evaluate the implementation of a status natural approach to adolescent sexual health care including sexual health education, HIV and STI testing, and linkage to PrEP for middle and high school students attending an alternative school in Alabama.

• PI: Anne Spaulding, MD, MPH, Rollins School of Public Health, Emory University
• Mentor: April Pettit, MD, MPH

Abstract

We support a rapid medical response to persons with HIV (PWH), or persons at high risk of seroconversion (PHRS), who are identified through a point-of-care HIV testing program at intake to Fulton County (Atlanta, Georgia) Jail and ultimately link them with care to reduce HIV transmission. For persons with HIV, we facilitate treatment by starting or continuing with antiretroviral therapy (ART) regimens, including Long-Acting Anti-Retroviral Therapy (LA-ART), and linkages to care to maintain medication adherence, thereby potentially preventing future cases of HIV. Taking a status neutral approach, we plan to implement point-of-care testing to identify negative, high-risk cases and follow a similar pathway to promote uptake of Pre-exposure Prophylaxis (PrEP), further promoting prevention. We focus on intake, clinical encounters, discharge and referral to community clinic processes and integration of a case management team, composed of a case manager and a peer navigator, to provide seamless coordination of care from intake to community reintegration. The peer navigator, an integral member of the study team, is a person with lived experience of detention and either living with HIV or at some point in time at high risk for seroconversion. Our approach has the potential to improve the overall health of an underserved, predominantly minority population. Previously, under a R34, we developed a manualized, multi-session strength-based case management intervention, SUCCESS (Sustained, Unbroken, Connection to Care, Entry Services, and Suppression). This study will pilot test an Enhanced version of SUCCESS (SUCCESS-E), which uses a peer navigator to assist the case manager, to promote uptake of PrEP and treatment of HIV, accommodate new forms of ART, and establish linkages to care post release. Our study has three specific aims:

• Aim 1a. Reshape SUCCESS to include a peer navigator to extend the case manager, develop a referral process for clients in a status neutral manner, and address increasing use of injectable LA-ART.
• Aim 1b: Use implementation strategies: establish relationships with jail: managers, clinicians, and nurses, and after educational sessions to refine processes for seamless transition for PWH/PHRS to community clinics; and educate jail and community providers, to disseminate best practices on ART/PrEP care for transition from jail.
• Aim 2: Pilot test the SUCCESS-E model with 20 persons, including both PWH and PHRS in a status-neutral manner, and determine reach, effectiveness, and adoption of the program.
• Aim 3: Determine the resource requirements and costs associated with adoption and implementation of SUCCESS-E, including those associated with adjustment of jail processes and the ongoing costs.

The main analysis: will focus on implementation outcomes, and for this we will use the RE-AIM Framework to study Reach, Effectiveness, Adoption, Implementation and, to a limited extent, Maintenance.

Project Narrative

This study will provide pilot data for a future proposal to improve, after jail release, active treatment and prevention with antiretrovirals, including long-acting agents, in a status neutral manner: treatment for persons who have HIV, and pre-exposure prophylaxis for those who are at high risk for seroconversion. We will use implementation science to introduce innovations in transitional care, including peer navigation. Ultimately, the strategy should reduce the incidence of new HIV cases by keeping persons with HIV virally suppressed and those at risk for HIV on preventive therapy.

• PI: Sophia Zamudio-Haas, DrPH, MSc, University of California San Francisco
• Mentor: Carolyn Audet, Ph.D.

Abstract

Despite advances in biomedical HIV prevention and treatment options, trans women and in particular Black and Latinx trans women, have been largely left out of the benefits of these advances, and continue to experience health disparities at every stage along the HIV continuum of care ^1-6. Social and structural inequities fuel health disparities, combined with a continued gap in programming to meet trans women’s unique needs. Latinx trans women in particular face marginalization in health care, due in part to lack of appropriate HIV education and information about services in Spanish and high levels of HIV-related stigma ^20,21. Research documents healthcare avoidance for trans Latinas, fueled by low levels of insurance coverage and concerns around detention due to undocumented status ^15,22 .

To address this urgent need for population specific HIV services, La Clinica de La Raza, an FQHC, partnered with UCSF to develop a trans-specific, status neutral approach to HIV programming, ‘TRIUMPH/Triunfo’. Initially designed as a PrEP prevention program ²³, Triunfo met with success engaging Spanish speaking Latinas in care, many of whom had previously never received services in formal medical settings. Since its launch, most of the social support components of the program have dropped off following the COVID-19 pandemic and overall healthcare engagement has also declined ²⁴. Our ongoing research demonstrates demand for social support opportunities and a need for Spanish-language education to combat HIV stigma. Although there is a relatively rich network of trans-specific services available in the San Francisco Bay Area compared to other regions in the US, there are limited services in Spanish to address the context of HIV risk for trans Latinas. By partnering with La Clinica, our team is well situated to study holistic HIV interventions to reduce HIV related stigma and increase healthcare seeking behaviors for this marginalized population.

Sheroes, developed by co-investigator Sevelius and team at the UCSF Center of Excellence for Transgender Health, is an evidence-informed, group level, status neutral HIV intervention for trans women ¹⁶. We propose to use a structured, participatory approach to adapt the intervention culturally and linguistically for Spanish speaking trans Latinas and test the feasibility and acceptability through pilot implementation. In collaboration with our community partner, La Clinica de La Raza, the intervention will include linkage to comprehensive HIV services, including HIV testing, PrEP, PEP, and HIV care. We will use the pilot data from this study to develop a future R-level NIH proposal (e.g., a Type 1 hybrid effectiveness/implementation study), with the goal of producing a replicable, culturally relevant, evidence-based HIV prevention intervention for Spanish-speaking transgender women. Our application addresses high priority areas of the NIH HIV/AIDS Research Priorities (NOT-20-018) including research to reduce health disparities in the incidence of new HIV infections or in treatment outcomes of those living with HIV/AIDS as well as developing, testing, and implementing strategies to improve HIV testing and entry into prevention services.

• Specific Aim 1: To utilize a systematic adaptation process to produce a linguistically and culturally adapted curriculum based on ‘Sheroes’, an HIV prevention and treatment intervention designed for English speaking trans women, to be implemented with Spanish speaking Latina trans women in the SF Bay Area. To accomplish this, we will integrate the input of key stakeholders (potential participants, agency staff) to draft an adapted intervention, translate and back-translate materials from English to Spanish, and gather feedback via two focus groups (6-8 participants each, total n=16) from potential participants and community experts on draft materials and descriptions of intervention activities.
  
• Specific Aim 2: To test the feasibility and acceptability of the adapted intervention. We will accomplish this by conducting a small (n=8) pilot study of the adapted intervention. We will train existing peer health educator (PHE) staff at La Clinica to conduct a pilot implementation of the preliminary version of the adapted curriculum. The pilot will occur over six to eight weeks, covering one module per week. We will document quantitative feasibility data (e.g., staff hours required) and conduct qualitative interviews with facilitators (n=2) and participants (n=8) to evaluate: (a) feasibility of implementation procedures, (b) acceptability of program content and activities including culturally adapted elements, and (c) suggestions for improvements. We will use feedback from the pilot study to further refine the curriculum that will serve as the basis of an R-series proposal to conduct a full efficacy trial.

• PI: Cedric Bien-Gund, MD, MSCE, University of Pennsylvania
• Mentor: Carolyn Audet, PhD

Abstract

Ending the HIV Epidemic will require multi-sectoral efforts to maximize the dissemination and availability of HIV testing and pre-exposure prophylaxis (PrEP). Pharmacies can fill an important gap in delivering PrEP to populations affected by HIV and have many advantages over conventional clinic-based care models, including increased accessibility, established community trust, and experience providing medication counseling. The overarching goal of this supplement application is to advance the science of implementing pharmacy-based rapid HIV testing and PrEP, two evidence-based practices that remain underutilized among populations affected by the HIV epidemic. Consistent with NOT-AI-23-016, this study will examine key questions regarding the implementation of pharmacy-based rapid HIV testing and PrEP initiation in communities with high burden of HIV in Philadelphia, Pennsylvania, an urban area prioritized by the Ending of HIV Epidemic initiative. We hypothesize that a pharmacy-based PrEP delivery model will be acceptable, feasible, and appropriate and that individuals will uptake pharmacy-based PrEP. The study will pursue three research aims:

Aim 1: Identify implementation barriers and facilitators of pharmacy-based HIV testing and PrEP initiation. Informed by the Consolidated Framework for Implementation Research (CFIR) and the Health Equity Implementation Framework (HEIF), we will conduct a mixed methods study using in-depth interviews with stakeholders and a survey of pharmacists to identify implementation determinants and assess implementation readiness of pharmacy-based PrEP.

Aim 2: Determine optimal implementation strategies for pharmacy-based HIV testing and PrEP delivery. We will conduct focus group discussions with pharmacists and stakeholders to determine optimal strategies and mechanisms to maximize implementation success of the intervention.

Aim 3: Evaluate the implementation of a community-based, pharmacist-led HIV testing and rapid PrEP initiation intervention. Using the Proctor framework of implementation outcomes, we will pilot the intervention in community pharmacies and conduct a mixed methods study to assess acceptability, feasibility, appropriateness, and reach of the program.

The research will be implemented through a collaborative effort with partners from the Penn Center for AIDS Research, Philadelphia Department of Public Health, Philadelphia College of Pharmacy, and local community pharmacies. Completion of research aims will provide key data on an adaptable model for widespread implementation of pharmacy-based HIV testing and PrEP. Moreover, the project will support local EHE efforts by capacitating pharmacists to provide rapid HIV testing and promptly initiate PrEP. Evidence and insights generated from this research will be used to test the efficacy of the intervention at scale in a Type II hybrid effectiveness-implementation clinical trial.

• PI: Charlie Burnes, MD
• Mentors: April Pettit, MD, MPH

Abstract

In order to improve HIV pre-exposure prophylaxis (PrEP) use and reduce transmission of HIV in the South we plan to leverage community-based pharmacies as novel access points to PrEP. While pharmacists are unable to independently prescribe PrEP in this region, we plan to empower them to provide PrEP counseling and referrals to local PrEP clinics. Together, our proposed project will make PrEP accessible to persons who may not be able or willing to present to current PrEP access points such as academic health centers and public health departments and will work through the Ending the HIV Epidemic initiative goal of a 90% reduction in in new HIV diagnoses by 2030 through the Pillar of Prevention.

 Aim 1: Describe the perceived accessibility and feasibility of an independent community pharmacy driven PrEP-referral program

Aim 2: Assess implementation of a community pharmacy driven PrEP-referral program

• PI: Mariano Kanamori, PhD, University of Miami Miller School of Mediciine
• Mentor: Byron Powell, PhD

Abstract

CERCA DE TI (“Close to You” in Spanish) is a new pharmacy chain-based PrEP

program that will leverage CVS Health services and infrastructure to help Latinx learn about PrEP, decide if PrEP is relevant for their lives, access PrEP, and sustain PrEP use. This project addresses the EHE Pillar“Protect.” The goals of this EHE pilot study are to explore and plan the groundwork needed for the future implementation of CERCA DE TI, and to determine if the necessary resources are available for effective future implementation. This application is supported by 5+ years of ongoing collaborations between Dr. Kanamori and CVS Health during which we implemented a pharmacy chain-based recruitment program to support a PrEP program implemented by our partner Latinos Salud.

 AIM 1: Evaluate Consolidated Framework for Implementation Research factors important for the implementation and sustainability of CERCA DE TI (outer setting, inner setting, characteristics of intervention, and process characteristics).

AIM 2: Identify modifiable factors within the outer setting and characteristics of individuals for successful delivery of PrEP information and a one-stop-shop PrEP program at CVS Health.

 With 85% of the U.S. population living less than 10 miles from a CVS Pharmacy venue, CERCA DE TI has the potential to scale-up to a national level.  This model could be replicated with other priority populations and regions of the U.S. and be expanded to also advance HIV testing and care.

• PI: Jeffrey Lane, JD, MPH, University of Washington
• Mentor: Amanda Mixon, MD, MS, MSPH, FHM

Abstract

An estimated 1.2 million people in the U.S. are eligible for HIV pre-exposure prophylaxis (PrEP), yet only 25% of these people were prescribed PrEP in 2020. Coverage is especially low among Black heterosexual women, Black and Latinx men who have sex with men, and people who inject drugs. Pharmacists could play an important role in addressing the gap in PrEP coverage. There are approximately 67,000 retail pharmacies in the U.S., many of which are co-located in communities disproportionately burdened by HIV. Pharmacies are also often open extended hours and may be perceived as less stigmatized than traditional health care facilities. Pharmacists are included in the National HIV/AIDS Strategy as an important component of expanding access to care and improving population health. State laws have historically prevented pharmacists from prescribing and initiating PrEP. Since 2019, however, approximately nine states have adopted laws allowing pharmacists to independently prescribe PrEP. Many of these laws require the pharmacist to complete a PrEP training course prior to becoming certified as an independent PrEP prescriber. Other states allow pharmacists to prescribe medications, including PrEP, under collaborative practice agreements with physicians. The heterogeneity in state laws governing pharmacist prescribing presents a natural experiment to study the real-world implementation and effect of laws permitting pharmacist-initiated PrEP on PrEP access and coverage. The first aim of this study is to measure the adoption of pharmacist-initiated PrEP in state laws, assess implementation variation between states by developing a taxonomy of pharmacist-initiated PrEP laws, and assess adoption of pharmacist-initiated PrEP among pharmacists. The second aim is to evaluate the reach of pharmacist-initiated PrEP by assessing how many patients have received pharmacist-initiated PrEP by state and 3-digit zip code and how the demographic characteristics of patients receiving pharmacist-initiated PrEP compare to the demographics of patients receiving PrEP prescriptions from other types of prescribers. These analyses will be conducted nationally and specifically for King County, Washington. The results will help identify where pharmacist-initiated PrEP has had the greatest adoption and reach and identify regions and communities that may benefit from improved implementation.

• PI: Jade Pagkas-Bather, MD, MPH
• Mentor: Aima Ahonkhai, MD, MPH, University of Chicago Medicine

Abstract

This study seeks to determine the acceptability, feasibility, and appropriateness of a pharmacy-led pre-exposure prophylaxis (PrEP) program among a cohort of patients living on the south side of Chicago, the largest contiguous Black community in the United States. A pharmacy-led PrEP model would relegate all PrEP-related care within a pharmacy site, including prescriptions written by pharmacists, (thereby not requiring a physician or nurse practitioner visit), all lab draws, and STI screening, as well as counseling. This supplement application is informed by early research examining antiretroviral delivery preferences among young Black sexual minority men (YBSMM). This early research demonstrated that participants taking PrEP and antiretrovirals (ARV) for HIV treatment preferred both pharmacy pick-up options and mail delivery of medications due to the importance of both convenience and privacy, while they were unenthusiastic about obtaining ARV from a mobile van. Importantly, flexible options for HIV treatment and prevention were paramount for the cohort in the study. We will explore the patient population’s knowledge of and interest in both oral, and long-acting injectable PrEP (LAI-PrEP), and future formulations such as implants, gels, subcutaneous PrEP, as well as implants. The research will take place with patients living on the south side of Chicago receiving care from Chicago Family Health Center (CFHC), a representative federally qualified health center (FQHC) within our population centered health home (PCHH). The population at CFHC is predominantly Black and Latinx, and the clinic is situated in an area of the city with some of the highest rates of HIV. Furthermore, we will also assess the interest of pharmacists and pharmacy technicians in participating in a pharmacy-led PrEP intervention. This work is situated in the praxis of adapting services to clients’ needs, often called differentiated antiretroviral therapy (DART) which has the potential to scale up and use resources, in this case, pharmacies, more efficiently. The proposed study addresses priority #2 of the FY23 EHE CFAR Supplement Announcement focusing on “Leveraging Pharmacies to Advance HIV Testing, Prevention, and Care”. We plan to examine the acceptability, feasibility, and appropriateness of a pharmacy-led PrEP start program.

Aim 1: Assess current knowledge and attitudes about PrEP in its various modalities (as well as future formulations) for HIV prevention among patients at Chicago Family Health Center. In order to achieve Aim 1, we will conduct focus groups among patients who meet CDC criteria for PrEP²⁸, its benefits and side effects, barriers and facilitators to its use, and criteria for prescription.

Aim 2: Examine the acceptability, feasibility, and appropriateness of pharmacy-led PrEP from the perspective of patients, pharmacists, and pharmacy technicians. PrEP-eligible patients from CFHC, local pharmacists, and pharmacy technicians will be interviewed to assess the acceptability, feasibility, and appropriateness of pharmacy-led PrEP. This will provide pre-implementation data to inform the key elements of a  pharmacy-led PrEP program. Information obtained from this aim will be utilized to form an expert panel for the creation of an implementation manual and refinement of an Implementation Research Logic Model (IRLM), as well as future implementation of pharmacy-led PrEP at a single pharmacy.

• Implementation Outcomes Crosswalk | HIV Implementation Science Coordination Initiative (northwestern.edu)

• Toolkit Part 1: Implementation Science Methodologies and Frameworks – Fogarty International Center @ NIH
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• What is Implementation Science? | Implementation Science at UW (impsciuw.org)
• Implementation Science – Harvard Catalyst
• Implementation Science Training | Center for Healthcare Improvement and Medical Effectiveness — CHIME (ucsf.edu)
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• HIV Implementation Science Coordination Initiative | (northwestern.edu)

• TN CFAR Implementation Science Hub – YouTube