An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)

The purpose of this small randomized clinical trial was to develop and test the Enhanced Sexual Health Intervention for Men (ES-HIM), designed for non-gay identifying HIV-positive African American MSMW with histories of childhood sexual abuse (CSA). The investigators compared ES-HIM to an attention matched general Health Promotion intervention (HP) on efficacy in reducing: a) sexual risk behaviors (i.e., unprotected anal and vaginal sex and number of sex partners); b) psychological symptoms of PTSD and depression; and c) a biological composite of primary neurohormonal mediators of the stress response (cortisol and catecholamines). The investigators also explored the intervention effects on neopterin, an indicator of HIV disease progression, as an outcome. Project Aims 1. To determine the impact of the ES-HIM intervention on HIV sexual risk behaviors among non-gay identifying HIV-positive African American men who have sex with men and women (MSMW) who have histories of childhood sexual abuse (CSA). The investigators hypothesize that compared to the Health Promotion comparison condition, the ES-HIM condition will be more effective in decreasing unprotected anal and vaginal sex (i.e., increase condom use) and number of sexual partners at immediate post-intervention and at 3- and 6-months post-intervention. 2. To determine the impact of the ES-HIM intervention on negative psychological symptoms over time among non-gay identifying HIV-positive African American MSMW who have histories of CSA. The investigators hypothesized that compared to the Health Promotion condition, the ES-HIM condition will be more effective in decreasing depressive and posttraumatic stress symptoms at immediate post-intervention and at 3- and 6-months post-intervention. In addition to these aims, the investigators also explored associations between HIV sexual risk behaviors (i.e., unprotected anal and vaginal sex), negative psychological symptoms (i.e., depressive \& posttraumatic stress symptoms) and biomarkers of allostatic load over time among ES-HIM participants. Research Methods The University of California, Los Angeles (UCLA) ES-HIM Project was a 4-year study conducted from 2007-2011 to develop and test an HIV risk and stress reduction intervention. Institutional Review Board (IRB) approval for the protection of human subjects in research at UCLA and a Certificate of Confidentiality from the National Institutes of Health (NIH) were obtained. Intervention Procedures HIV-positive African American MSMW were recruited through fliers posted at participating community-based organizations, as well as through outreach at community events, bars, clubs, and other locations where the target population may be present. Once interested potential participants were screened and deemed eligible, informed consent was obtained. After informed consent, participants were asked to complete a baseline survey, as well as complete locator forms. Upon completion of the baseline survey, participants were randomized into the ES-HIM active intervention group or the Health Promotion control condition. Both the ES-HIM and the Health Promotion included six sessions, with each session lasting two hours; two sessions were administered per week for three consecutive weeks. The primary aims of the ES-HIM intervention were to increase condom use and decrease symptoms of depression and posttraumatic stress. Within these six, 120-minute sessions, active ES-HIM intervention participants had the opportunity to discuss their sexual experiences and issues of masculinity and stigma associated with being African American, HIV-positive, and a non-gay identifying MSMW. The Health Promotion condition focused on improving general health and concentrated on diet, exercise, relaxation/sleep hygiene, and medication adherence. Both the ES-HIM and Health Promotion curricula were delivered by trained Facilitators. Data Collection Enrolled participants were administered surveys via Audio-Computer Assisted Self Interview (A-CASI) at four time points: baseline, immediate post-intervention (upon completion of the sixth ES-HIM or Health Promotion session), and at 3- and 6-months post-intervention. Also, participants were asked to provide 12-hour urine collections for biomarkers of stress and a one time urine sample for neopterin at baseline and 3- and 6-months post-intervention. Non-urinary biomarkers, including height and weight (body mass index), heart rate, blood pressure, and waist-to-hip ratio measurements were collected at these same time points. Data collection (i.e., survey administration, urine container drop-off, and non-urinary biomarker measurements) were administered in confidential settings at collaborative community agencies and/or UCLA.