2.1. Overview
HIV viral suppression
SECONDARY
The present mixed methods study is a pilot optimization trial, grounded in the MOST framework. The proposed study took place between 9/2020 and 1/2022 in the New York City metropolitan area, a COVID-19 epicenter. The study was carried out entirely virtually, as in-person activities with human subjects were prohibited at our institution due to COVID-19 restrictions. The study's primary outcome was HIV viral suppression, and viral load levels were a secondary outcome. We used an efficient factorial design to explore three behavioral intervention components, each designed to address specific barriers to HIV viral suppression in this population. The goals of the present study are to examine the acceptability and feasibility of the intervention components and explore preliminary evidence of their effects on factors believed to mediate changes in the primary outcome and on the primary and secondary outcomes, in order to inform future research. We enrolled 80 African American/Black and English-speaking Latino PLWH with non-suppressed HIV viral load (>200 copies/mL). Participants received a baseline assessment and follow-up assessments at 4- and 8-months post-baseline. With support of the study team, they provided a recent laboratory report including HIV viral load levels at each of the three assessment periods. Participants were randomly assigned to one of 8 experimental conditions, each comprised of a unique combination of intervention components or component levels. Consistent with the sequential explanatory mixed methods design, we used the quantitative results to develop a set of research questions that could be addressed using qualitative data, and then results from the two analyses were integrated using the joint display method. The study used the field name “Silver Community Action Project 2” (S-CAP2). Results were interpreted in the context of the COVID-19 pandemic, which impeded HIV management and other aspects of participants' lives, and the fact that all activities were carried out virtually, almost always by phone, since participants generally did not have smartphones or computers that would allow for Telehealth. Compensation was provided to participants using the Greenphire ClinCard system, a refillable debit card for research compensation. The study was approved by the Institutional Review Board at New York University and participants gave verbal informed consent for study activities.