Long Acting Injectable PrEP Implementation

Principal Investigator:  Robert Deiss, MA MD, UC San Diego

Budget:  $1,479,991

Start Date: February 1, 2024        End Date: January 31, 2028

Project Abstract: Despite an increased risk for HIV acquisition, PrEP uptake remains unacceptably low among people who use drugs (PWUD). Long-acting injectable (LAI) PrEP offers a promising and preferred strategy for PWUD, yet effective interventions to improve linkage and retention in care are urgently needed. To develop best practices for engaging PWUD in LAI-PrEP services, we propose comparing outcomes (LAI-PrEP linkage and retention in care at 12 months) of participants recruited via two novel methods: (1) community-based recruitment implemented in collaboration between the Harm Reduction Coalition of San Diego (HRCSD) and UCSD’s Owen Clinic and (2) hospital-based recruitment and referral to the Owen Clinic with a patient care navigator. First, the community-based outreach method will consist of mobile LAI-PrEP services provided at various community locations in conjunction with harm reduction services provided by the HRCSD. This partnership will support expanding the HRCSD’s services to include LAI-PrEP, which will be offered to all eligible and interested PWUD in the community. Second, our hospital-based recruitment method will leverage the Owen Clinic’s proximity to UCSD’s Hillcrest Medical Center, where hospital admissions represent a critical moment for individuals experiencing complications from substance use disorders (SUD). For instance, during the 12-month period between July 2020-2021, there were 6,231 admissions among HIV-negative PWUD, primarily involving drug-related overdose or serious bacterial infections. Our study team, which possesses extensive expertise in addressing the intersection between HIV and SUD, will assign a patient care navigator to identify and recruit patients with SUD at risk of HIV acquisition; eligible participants interested in PrEP will be linked to the Owen Clinic and receive referrals to HRCSD’s harm reduction services and medications for treatment of SUD that are also known to promote improved retention in HIV services. The Owen Clinic is San Diego’s oldest and largest provider of HIV primary care services with wrap-around supports for socio-economically diverse communities, including 300 persons receiving PrEP (45% non-white). It has an on-site pharmacy, behavioral health/substance use counselors, on-site social work, psychiatry, gender health care, and referrals to other needed social services.

Principal Investigator:  Betty Dong, PharmD, UC San Francisco

Budget:  $1,751,000

Start Date: February 1, 2024        End Date: January 31, 2028

Project Abstract:  The CDC recognizes pharmacists as key in ending the HIV epidemic by 2030. Pharmacist provision of long acting injectable (LAI) and oral pre-exposure prophylaxis (PrEP) has the potential to reduce persistent disparities in PrEP uptake by reducing access barriers. California has over 5,500 pharmacies, the most of any state. About 90% of the U.S. population reside within five miles of a community pharmacy. In 2022, we conducted a study of >900 California pharmacists and found that 96% of pharmacists supported providing PrEP and 65% were interested in providing LAI PrEP if enabled to do so. Despite the favorable policy environment in California, only 11% of pharmacists reported that their pharmacy was currently providing oral PrEP. Implementation strategies tailored to the unique opportunities and constraints of community pharmacies are, therefore, urgently needed. Our proposed project will facilitate LAI PrEP access and uptake in California pharmacies by implementing a comprehensive model of LAI PrEP administration, HIV testing, and counseling that can be incorporated into existing workflows and align with current pharmacy business models. We will first co-create an implementation strategy for LAI PrEP which will be implemented in California pharmacies in Years 1-2 (Aim 1) . Concurrently, we will evaluate (Aim 2) its success at reaching high-priority groups with PrEP throughout the study period (Years 1-4). In addition, to measure the statewide evolution of pharmacist-delivered PrEP, we will conduct a population-based, representative statewide pharmacy survey of approximately 1,000 pharmacies in Year 3 to describe trends in pharmacy-based HIV prevention services; identify ‘PrEP deserts’; and uncover implementation successes, challenges, and opportunities related to such services (Aim 3).

Principal Investigator:  Sheldon Morris, MD MPH, UC San Diego

Budget:  $1,756,178

Start Date: February 1, 2024        End Date: January 31, 2028

Project Abstract:  Long-acting injectable HIV Pre Exposure Prophylaxis (LAI PrEP) is now available with injectable cabotegravir, and options will increase as new agents receive FDA approval. Our published research (Yeager et al., 2022) indicates a highly favorable appeal of LAI PrEP to enhance adherence, thereby conferring therapeutic coverage against HIV infection. However, logistical challenges at multiple points within the health care delivery system have limited LAI PrEP uptake. This project aims focus on implementation from both the supply and demand perspectives. As an early adopter of LAI PrEP, the UCSD Owen Clinic is positioned to share lessons related to supply challenges with other pharmacies in the region. To this end, we will engage community pharmacies in a coalition to foster shared learning to overcome barriers to pharmacy-delivered LAI PrEP using the Owen Clinic pharmacy as a model (i.e., blueprint) that can be adapted to fit the context of other communities and then piloted in their respective environments. Given that infrastructure, resources, and barriers will differ from site to site, but by keeping the implementation blueprint “living and accessible,” this will prepare settings to adopt, implement, and scale up LAI PrEP more efficiently. This flexibility will enable us to respond to new injectable formulations of PrEP that may come online during the project period and to policy changes that may impact the implementation of LAI PrEP. Furthermore, our engagement with Black and Latinx MSM and transgender communities will uncover social determinants influencing demand for LAI PrEP. Throughout the project we will closely monitor both the supply and demand of LAI PrEP in Southern California.

Principal Investigator:  Risa Hoffman, MD MPH, UC Los Angeles

Budget:  $2,022,247

Start Date: February 1, 2024        End Date: January 31, 2028

Project Abstract:  We propose to partner with the Los Angeles County (LAC) Division of HIV and STD Programs (DHSP) and two of their long-term community partners, The Sidewalk Project (TSP) and Downtown Women’s Center (DWC), on a demonstration project of field-based delivery of long-acting cabotegravir (CAB) PrEP to cisgender women (CGW) and transgender women (TGW) who are being reached for syphilis treatment due to challenges with accessing facility-based care. We will evaluate uptake of CAB and persistence over 52 weeks and perform key informant interviews with DHSP leadership, field-based staff, and community leaders as well as cost analyses to understand the scalability and sustainability of this approach. CAB has been shown to be superior to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for the prevention of sexual HIV acquisition. In recent randomized clinical trials, CAB was associated with an 89% reduction in incident HIV infection in CGW and a 66% reduction in TGW and MSM, compared to TDF/FTC. California is one of five states that account for half of all women living with HIV in the US, and LAC represents a hyper-localized epidemic within California. Additionally, the prevalence of HIV in TGW in LAC is 17%, rising to 27% in Black TGW, and 28% in TGW with substance use disorders. Syphilis is a biologic risk factor for HIV acquisition and is increasing among CGW and TGW in LAC. Almost one-quarter of new HIV diagnoses in LAC have a diagnosis of syphilis. Therefore, any CGW or TGW without HIV who has been diagnosed with syphilis is an ideal candidate for CAB PrEP – and a focus on this population will be essential for ending the HIV epidemic in LAC. Our proposed demonstration project uses a mobile model to address the critical barrier of health access for clients who face challenges in seeking care at health facilities. It leverages expertise of leaders in public health, academics, and community. The study has been designed to understand aspects of scalability and sustainability that will optimize the translation of knowledge to program and policy changes in LAC and similar high burden, resource-constrained settings in the United States.

Principal Investigator:  Kimberly Koester, PhD, UC San Francisco

Budget:  $1,987,789

Start Date: February 1, 2024        End Date: January 31, 2028

Project Abstract:  Our community centered demonstration project, Breaking Barriers: Building Equitable Access to Long-Acting Injectable PrEP in Sacramento and Fresno Counties seeks to support widespread access to and uptake of long-acting injectable PrEP (LAI-PrEP). The goal of this project is to build equitable access to LAI-PrEP among gay, bisexual, and same gender loving men, heterosexual women, and transgender persons, particularly among racial and ethnic minoritized communities. To do this, we will deliver and evaluate a non-traditional provider-facing capacity building strategy using lessons learned in our recent community-academic project which includes members of the Sacramento Zero Together and implementation scientists from UC, San Francisco. We carried out a study of preferences for sexual health services in Sacramento among gay, bisexual and same gender loving men. We used innovative methods to elucidate service priorities and revealed a strong interest in LAI-PrEP. Results showed that men face intense challenges to accessing LAI-PrEP. Building on this research, we seek to dramatically increase the capacity of traditional and non-traditional providers to make LAI-PrEP available in Sacramento and Fresno Counties, under-resourced areas facing a pernicious HIV and STI syndemic. Collaborators range from county health departments, community-based organizations, specialty pharmacy, federally qualified health centers, syringe exchange programs, and mobile health units. We envision a tiered plan to initiate in Sacramento and then scale to Fresno.  In Aim 1 we will leverage the Consolidated Framework for Implementation Research, a determinants framework, to conduct a formative assessment of the barriers and facilitators to LAI-PrEP implementation and uptake in Sacramento and Fresno Counties. In Aim 2 we will convene a PrEP navigator advisory board to develop resources specific to the navigator workforce e.g., payer source tools, patient education materials. In Aim 3 we will establish and evaluate a Learning Collaborative designed to facilitate peer-to-peer learning and tailored strategies to overcome LAI-PrEP implementation barriers.  Aims will be carried out with two traditional and two non-traditional Sacramento organizations in Tier 1; extend to three traditional and one non-traditional Fresno organizations in Tier 2; and scale community-wide in both counties in Tier 3.