Recommendations for the Design and Implementation of Alcohol Pharmacotherapy Trials: Perspectives of Women With HIV Participating in the WHAT-IF Study.

Objectives: Naltrexone for alcohol reduction has been poorly studied in women with HIV (WWH), for whom heavy alcohol use is associated with negative HIV outcomes. This study offers recommendations for researchers conducting alcohol pharmacotherapy trials among PWH as suggested by WWH who participated in an alcohol pharmacotherapy trial in Florida.

Methods: The WHAT-IF? Study enrolled WWH with a history of heavy alcohol use in Miami, Florida, into a clinical trial where participants were randomized to receive naltrexone or placebo to assess effectiveness among WWH. Twenty participants (mean age, 49 years; 85% Black/African American) completed interviews that included questions about barriers to participation and recommendations for future researchers and WWH. Interviews were analyzed using a reflexive thematic approach.

Results: We identified six recommendations: 1) increasing opportunities for study engagement, 2) fostering positive relationships to support change, 3) addressing medication concerns, 4) considering structural barriers to participation, 5) improving alcohol-related education, and 6) preventing fraudulent participation. Positive relationships included both study staff and external support. Medication concerns included cost, accessibility, and adherence. Structural barriers included transportation, substance use, and mental health conditions. Better education included information on the risks of alcohol use and encouraging women to quit. Overall, women reported having positive experiences in the WHAT-IF? trial, and many recommended that the study continue.

Conclusion: Future alcohol pharmacotherapy studies could consider these recommendations when working with women from underserved communities, including WWH. Additionally, these recommendations could be applied to increase alcohol pharmacotherapy uptake and adherence in clinical practice.