A behavioral intervention for Black men who have sex with men and live with HIV to address intersectional stigma and improve antiretroviral therapy adherence

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7. Project Summary/Abstract Intersectional stigma based on race, sexual orientation, and HIV-status reduces antiretroviral therapy (ART) adherence among Black men who have sex with men (BMSM) and live with HIV (LWH), a group heavily affected by the HIV epidemic in the US. Low ART adherence is associated with a higher risk of virological failure as well as morbidity, mortality, and HIV transmission to HIV-negative partners. Evidence-based interventions (EBIs) for BMSM/LWH to address the ART adherence barriers due to intersectional stigma are still lacking. Phone-based reminder systems like ARemind can increase ART adherence with a medium/high effect size, but their effect on viral suppression remains poorly understood. Reminder-based interventions address sporadic non-adherence or single missed ART doses due to forgetfulness that has minimal impact on viral suppression. They do not address sustained non-adherence resulting from social and structural factors including intersectional stigma. Sustained non-adherence is a risk factor for virological failure. Sporadic and sustained non-adherence worsens HIV-induced chronic inflammation (e.g., high interleukin[IL]-6 levels), thereby increasing morbidity and mortality risk. The candidate seeks training and research experience to desi gn and pilot test a technology-enhanced, culturally-sensitive EBI for BMSM/LWH to address sporadic and sustained non-adherence. Through this K01 Award, he will accomplish the following Training Goals (TGs): TG1. To develop skills in behavioral intervention research; TG2. To gain skills in qualitative research methods; TG3. To acquire proficiency in the assessment and interpretation of biomarkers of ART adherence and chronic inflammation. These TGs coupled with the candidate’s expertise in quantitative methods, biopsychosocial stigma models, and clinical psychology will barriers to ART adherence faced by due to intersectional stigma and strategies to counter these barriers through RA2. Design a technology-enhanced, culturally-sensitive EBI addressing intersectional stigma-related barriers to ART adherence for BMSM/LWH; enable him to achieve the following Research Aims (RAs): RA1. Identify BMSM/LWH in-depth interviews with ~30 BMSM/LWH; RA3. Evaluate the feasibility, acceptability, and effect size estimates of the EBI (RA2) through a pilot RCT with 60 BMSM/LWH. The EBI (RA2) will combine ARemind with the Effective Skills to Empower Effective Men (ESTEEM) intervention’s strategies. Because these strategies focus on sexual orientation stigma, the candidate will adapt them for BMSM/LWH to address intersectional stigma-related barriers to ART adherence. Participants randomized to the experimental arm will receive the EBI (RA2). Participants in the control arm will receive ARemind only. The primary outcome is ART adherence based on self-report, Medication Event Monitoring System devices, and hair ART levels. The secondary outcomes are viral suppression and chronic inflammation. The pilot RCT findings will inform an R01 proposal that the candidate will submit in Year 4 of this Award. This K01 will set the candidate on a clear path to research independence.