A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Abstract: Compared to Whites, Black people living with HIV are less likely to adhere to antiretroviral treatment (ART) and be virally suppressed. Our research has identified culturally relevant factors contributing to disparities among HIV-positive Black Americans, including stigma and medical mistrust (e.g., “conspiracy beliefs,” that ART is poison), in addition to structural and psychosocial factors related to poverty, healthcare access, and mental health. However, ART adherence interventions have rarely been culturally congruent, which may explain why relatively few interventions have shown robust effects on adherence or viral suppression. We propose to conduct a randomized controlled trial (RCT) of Rise, a culturally congruent adherence counseling intervention for HIV-positive Black men and women. Rise counselors possess specialized HIV treatment knowledge and are trained in motivational interviewing (MI) skills to overcome culturally relevant barriers to adherence and retention in care; they also assist with linkage to social services. Rise is ideally implemented in community organizations, enabling clients to seek services in non-medical settings, which helps to overcome mistrust of healthcare, and increase readiness for adherence. In a pilot RCT, Rise led to increased adherence (measured by electronic monitoring) relative to a wait-list control group over time, showing a large effect size (Cohen’s d=.87). However, the pilot did not evaluate effects on viral suppression or include long-term follow-up. Thus, we propose to conduct an RCT of Rise that follows best practices for evidence-based HIV treatment adherence intervention design and testing. The Specific Aims are: (1) To conduct a randomized controlled trial to examine the effects of a culturally congruent adherence intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; (2) To examine culturally relevant mediators (e.g., medical mistrust, stigma) that may help to explain the effects of the intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; and (3) To conduct a cost effectiveness analysis of the intervention. A total of 350 Black men and women will be randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 12- months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 12-months post-baseline. If Rise is found to be effective, the next step would be to conduct research to determine effective and feasible methods for intervention implementation and dissemination to community settings.
Project Number: 1R01NR017334-01