Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania. METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania's implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials. DISCUSSION: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.

Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial.

BACKGROUND: Stigma and discrimination related to sexuality, race, ethnicity, and HIV status negatively impact HIV testing, engagement in care, and consistent viral suppression (VS) among young Black and Latinx men who have sex with men and transgender women who have sex with men (YBLMT). Few interventions address the effects of intersectional stigma among youth living with HIV and those at risk for HIV within the same virtual space. OBJECTIVE: Building on the success of the HealthMpowerment (HMP) mobile health (mHealth) intervention (HMP 1.0) and with the input of a youth advisory board, HMP 2.0 is an app-based intervention that promotes user-generated content and social support to reduce intersectional stigma and improve HIV-related outcomes among YBLMT. The primary objective of this study is to test whether participants randomized to HMP 2.0 report improvement in HIV prevention and care continuum outcomes compared with an information-only control arm. We will also explore whether participant engagement, as measured by paradata (data collected as users interact with an mHealth intervention, eg, time spent using the intervention), mediates stigma- and HIV care-related outcomes. Finally, we will assess whether changes in intersectional stigma and improvements in HIV care continuum outcomes vary across different types of social networks formed within the intervention study arms. METHODS: We will enroll 1050 YBLMT aged 15 to 29 years affected by HIV across the United States. Using an HIV-status stratified, randomized trial design, participants will be randomly assigned to 1 of the 3 app-based conditions (information-only app-based control arm, a researcher-created network arm of HMP 2.0, or a peer-referred network arm of HMP 2.0). Behavioral assessments will occur at baseline, 3, 6, 9, and 12 months. For participants living with HIV, self-collected biomarkers (viral load) are scheduled for baseline, 6, and 12 months. For HIV-negative participants, up to 3 HIV self-testing kits will be available during the study period. RESULTS: Research activities began in September 2018 and are ongoing. The University of Pennsylvania is the central institutional review board for this study (protocol #829805) with institutional reliance agreements with the University of North Carolina at Chapel Hill, Duke University, and SUNY Downstate Health Sciences University. Study recruitment began on July 20, 2020. A total of 205 participants have been enrolled as of November 20, 2020. CONCLUSIONS: Among a large sample of US-based YBLMT, this study will assess whether HMP 2.0, an app-based intervention designed to ameliorate stigma and its negative sequelae, can increase routine HIV testing among HIV-negative participants and consistent VS among participants living with HIV. If efficacious and brought to scale, this intervention has the potential to significantly impact the disproportionate burden of HIV among YBLMT in the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03678181; https://clinicaltrials.gov/ct2/show/study/NCT03678181. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24043.