Reducing Human Immunodeficiency Virus and Sexually Transmitted Infections Risk in African American Women with At-Risk Male Partners: A Randomized Trial.

Background: We examined the efficacy of the Females of African American Legacy Empowering Self (FemAALES) intervention in a cohort of 203 publicly insured Black women in Los Angeles. Materials and Methods: Women who reported recent sex with a male partner who was at increased risk for infection by human immunodeficiency virus (HIV) and sexually transmitted infections (STI) were randomized to the six-session FemAALES intervention or to a single client-centered family planning and STI/HIV counseling session. Participants were followed at 3 and 9 months post-intervention. To investigate between-group behavioral changes in condomless sex in the prior 90 days and other HIV/STI risks, we used generalized estimating equations that accounted for repeated observations in individuals. Results: Most participants (mean age 34 ± 11 standard deviation) were low-income and unemployed, despite three-quarters having completed high school or the equivalent. The most common HIV/STI risk factors among recent male partners were incarceration (58.8%) and concurrent sex with other women (72.2%). At 3 months, the FemAALEs group showed a larger increase in the odds of asking their partner to test (adjusted odds ratio = 2.14; 95% confidence interval [CI], 1.02-4.47; p = 0.0431) and in sexual health self-efficacy scores (adjß = 1.82; 95% CI, 0.02-3.62; p = 0.0471) compared to the control group, although these changes did not hold at 9 months. Both groups showed statistically significant declines in the frequency of several sexual risk factors between baseline and 9 months. Conclusion: Although we did not find evidence that the FemAALES intervention was more efficacious than the less-intensive control condition in reducing sexual risk behaviors, the overall declines in risk behaviors we observed warrant further research. ClinicalTrials.gov (Identifier: NCT02189876).