Adaptation of a digital health HIV prevention intervention for black heterosexual couples in new york state

This Project Grant award from the National Institute of Mental Health (NIMH), authorized under the Mental Health Research Grants program (CFDA 93.242), is for $692,070 to adapt and pilot test a digital health HIV prevention intervention for Black heterosexual couples in New York State. The primary objectives are to: 1) Adapt an existing digital health intervention to meet the specific needs of this target population; and 2) Conduct a 6-month pilot randomized controlled trial with 60 couples to assess the feasibility, acceptability, and preliminary impact of the adapted intervention. The adaptation will use human-centered design principles, while the pilot trial will evaluate outcomes such as HIV/STI awareness, adherence to a tailored relationship agreement, and improvements in relationship dynamics. The award was made to the University of Rochester, which will collaborate with a sub-awardee, Florida International University, to execute the project over 3 years starting September 2024.

Abstract

/ summary current HIV/STI prevention interventions for black heterosexual / opposite-SEX (bhos) couples in the US require an in-person modality and focus on specific subgroups (sero-doscordant, substance using). Digital health interventions (dhis) may provide one solution to expand access to tailored, couples-based HIV/STI prevention-care interventions that appeal to a wide variety of black heterosexual / opposite-SEX (bhos) couples in the U.S. With varying vulnerabilities to HIV and other stis. One couples-based DHI has reduced cisgender male couples' susceptibility to HIV and other stis. The DHI used a hybrid format with individuals first completing a sequence of pre-determined modules (i.e., HIV/STI education, instructional videos, a searchable sexual health resources database, activities including an agreement builder) followed by completing the sequence jointly with their partner, and then ending with a finalized, comprehensive sexual agreement containing HIV/STI prevention items. To examine the acceptability of this theoretically-driven, couples-based DHI for HIV/STI prevention, we conducted a multi-method pilot project with 28 bhos couples in new york state. Bhos couples reported high intervention acceptability (96%), and qualitative dyadic content and thematic analysis revealed explicit recommendations to enhance intervention relevancy for adapting the DHI to meet their specific relationship and sexual health needs. Given these preliminary findings, we propose to conduct a novel, 3-year mixed method study guided by the couples interdependence theory and the adapt-ITT model to adapt and pilot-test this DHI to meet the needs of bhos couples. Dyadic data will be collected via: a) quantitative assessments at baseline, month 3 and 6; b) HIV/STI screening at baseline and month 6; c) 7 different paradata outputs (intervention use); d) individual exit interviews at month 6. Our specific aims are: aim 1: adapt the intervention for bhos couples using the apapt-ITT model with human-centered design. Aim 2: conduct a 6-month pilot RCT with 60 bhos couples using a 2:2 block random allocation approach (intervention VS. 3-month, delayed control), stratified by dyad HIV serostatus (i.e. serodiscordant, seroconcordant). Feasibility will measure enrollment and retention rates. Acceptability will leverage mixed methods from 3 data sources: qualitative - to contextualize intervention engagement; paradata - to describe intervention use over time; quantitative - to assess usability, sexual health behavior and general wellness. Aim 3: examine preliminary intervention impact: 1) primary outcomes (mutual HIV/STI awareness; creation/adherence to a tailored relationship agreement, uptake/adherence of evidence- based biomedical strategies); 2) secondary outcomes (improvements in relationship dynamics including communication). Impact will be assessed via couples' outcomes over time, between trial arms, and for all couples. This study has high public health significance complemented with rigor and scientific premise to address a critical GAP in couples-based interventions.