RESUMO
BACKGROUND: Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. OBJECTIVE: This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. METHODS: In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. RESULTS: The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. CONCLUSIONS: This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56892.
RESUMO
Cisgender sexual minority men (SMM) and transgender women are disproportionately vulnerable to HPV-related anal cancer, but little is known about longitudinal predictors of high-risk human papillomavirus (hrHPV) infection in this population. As such, this analysis aims to identify factors associated with incident anal hrHPV infection in a diverse cohort of young SMM and transgender women. This study of HPV infection, nested within a larger cohort study, took place between October 2015 and January 2020. Participants completed a brief computer survey assessing HPV symptomatology, risk, and prevention alongside multi-site testing, in addition to biannual cohort study assessments. In the analytic sample of 137 participants, 31.6% tested positive for an anal hrHPV infection, with 27.0% and 29.9% testing positive for incident anal hrHPV infections at Visits 2 and 3, respectively. When adjusting for time between study visits, participants had significantly greater odds of incident anal hrHPV at Visit 2 if they had a concurrent HSV infection (AOR = 5.08 [1.43, 18.00]). At Visit 3, participants had significantly greater odds of incident anal hrHPV infection if they reported a greater number of sex partners in the previous month (AOR = 1.25 [1.03, 1.51]). Prevalence of cancer-causing HPV at baseline was high and many participants tested positive for additional types of anal hrHPV at subsequent visits. Risk for newly detected anal hrHPV infection was significantly associated with biological and behavioral factors. Our findings strongly indicate a need for programs to increase uptake of HPV vaccination and provide HPV-related health education for sexual and gender minorities.
