RESUMEN
BACKGROUND: Despite substantial investments in ending the HIV epidemic, disparities in HIV care persist, and there is an urgent need to evaluate novel and scalable approaches to improving HIV care engagement and viral suppression in real-world settings. OBJECTIVE: This paper aims to describe a study protocol for a pragmatic type II hybrid effectiveness-implementation randomized controlled trial comparing existing standard of care clinic HIV linkage, adherence, and retention (LAR) protocols to a mobile health (mHealth)-enhanced linkage, adherence, and retention (mLAR) intervention. METHODS: The study will enroll 450 participants from clinics in Baltimore City. Eligibility criteria include being ≥18 years of age, having a new HIV diagnosis or being HIV-positive and out of care, or being HIV-positive and deemed by clinic staff as someone who could benefit from linkage and retention services. Participants randomized to the intervention receive mHealth-supported patient navigation for 12 months. Participants in the control group receive the referring clinic's standard of care patient support. The primary outcome is HIV virologic suppression at 12 months. A subset of participants will be interviewed at 12 months to learn about their HIV care experiences and, for those in the intervention arm, their experiences with the mLAR intervention. This protocol was developed in collaboration with the Baltimore City Health Department (BCHD) and the Maryland Department of Health (MDH) and with input from a community advisory board. RESULTS: Enrollment began on February 25, 2020. As of August 11, 2022, 411 of the 450 target participants had been enrolled. CONCLUSIONS: Pragmatic implementation science trials designed with input from key stakeholders, including health departments and community members, can help evaluate the evidence for mHealth interventions to reduce HIV health disparities. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934437; https://clinicaltrials.gov/ct2/show/NCT03934437. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42691.
RESUMEN
As demonstrated by the consistently documented disproportionately high rates of HIV and STIs (sexually transmitted infections) among Black sexual minority men (BSMM), current efforts to develop responsive interventions to reduce HIV and other STIs within this population have not been sufficient. It is therefore critical that public health researchers reflect meaningfully on the ways in which they investigate HIV and STIs. Engagement with BSMM is crucial in addressing the disproportionately high rates of HIV and STIs experienced, and thus the goal of the current research was to identify community-developed strategies that may enhance community engagement in research with BSMM. Seven focus groups (N = 38) were held with cisgender BSMM ages 18 to 45 years in Baltimore, Maryland to explore how to better engage this population and improve HIV and STI research. Data analysis of the text was conducted using an iterative, thematic constant comparison process informed by grounded theory. Four distinct themes related to trust-building within the broader community emerged: (1) authentic engagement with the community, (2) increased transparency of the research process, (3) capacity building of research staff from the community, and (4) a balance of research and action. Strategies for researchers to build community trust were identified that are related to, but slightly distinct from, common discussions in the community engaged research literature that are centered more specifically on trust-building within community-academic partnerships. Engagement with BSMM is crucial in addressing HIV and STI health disparities. It is critical that community engagement also be a priority to policy makers, research institutions, and funding institutions.
