Methodological overview of an African American couple-based HIV/STD prevention trial.

OBJECTIVE To provide an overview of the National Institute of Mental Health Multisite HIV/sexually transmitted disease (STD) Prevention Trial for African American Couples conducted in 4 urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. DESIGN This is a 2-arm randomized trial, implementing a modified randomized block design, to evaluate the efficacy of a couples-based intervention designed for HIV-serodiscordant African American couples. METHODS The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV-serodiscordant heterosexual African American couples. There are 2 theoretically derived behavioral interventions with 8 group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction whereas the control was individual based and focused on health promotion. The 2 study conditions were structurally similar in length and types of activities. At baseline, participants completed an audio computer-assisted self-interview and interviewer-administered questionnaire and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. RESULTS The trial results will be analyzed across the 4 sites by randomization assignment. Generalized estimating equations and mixed-effects modeling are planned to test: (1) the effects of the intervention on STD incidence and condom use and on mediator variables of these outcomes and (2) whether the effects of the intervention differ depending on key moderator variables (eg, gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). CONCLUSIONS The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples-based clinical trials in HIV/STD risk reduction and can be generalized to other couples-based behavioral interventions.