STARS: Sistas Talking About Real Solutions

The primary aims of the study are: 1) to evaluate the efficacy of the HIV risk-reduction, safer sex relapse prevention condition relative to the general health and nutrition control condition in reducing HIV-associated sexual behaviors and incident STDs over a 12-month follow-up period; 2) to evaluate the efficacy of the HIV risk-reduction, safer sex relapse prevention condition relative to the general health and nutrition control condition in enhancing theoretically-derived mediators of HIV-preventive behaviors.

The study began recruitment into the main trial in October, 2002. By the close of the recruitment window in March 2006, 855 African American women had been randomized to either of the study conditions. The study participants were eligible if they were: (a) unmarried, (b) African American women, (c) ages 18-29, (d) not pregnant, (e) reported at least one act of unprotected sexual intercourse within the last 6 months and, (f) were members of one of the three Kaiser Permanente HMO study sites. The three medical facilities included the Cascade Kaiser Permanente Center, the Southwood Kaiser Permanente Center and, the Panola Kaiser Permanente Center. While there are other Kaiser Permanente Medical facilities in Atlanta, these sites were selected because of the high prevalence of African-American women.

Once recruited via a random selection process, participants returned to a Kaiser Medical Center on a specified Saturday morning for their baseline visit. At the baseline visit participants were: (1) provided a brief overview of the STARS study; (2) provided written informed consent; (3) asked to complete a one hour ACASI survey; (4) asked to provide self-obtained vaginal swab specimen that were assessed for four STDs (Chlamydia, gonorrhea, trichomonas, and human papilloma virus) and a new PCR procedure to detect the presence of sperm in vaginal specimen and; (5) randomized to one of the two study conditions using concealment of allocation techniques to minimize assignment bias.

The ACASI is guided by the Theory of Gender and Power and Social Cognitive Theory. The interview has sections on sociodemographics, sexual history, alcohol and drug use, attitudes and outcome expectations related to abstinence and condom use, peer norms, and stress and coping. The administration of the ACASI interview was enhanced by the inclusion of a 60-day calendar that participants complete prior to the interview. This allows a more realistic time frame to reference interview questions and time for the participant to recall and document behavior before beginning the interview. Upon completion of the full assessment, participants provided swabs for STI specimens. All participants with a positive test result were offered free directly observed therapy (DOT) at their participating medical center.

Participants were randomized to one of two study conditions: (1) an HIV safer sex risk-reduction condition with a relapse prevention component and; (2) a general health and nutrition control condition. the HIV safer sex risk-reduction condition consisted of two 4-hour safer sex workshops; the two workshops were guided by the Theory of Gender and Power and Social Cognitive Theory and; held on consecutive Saturdays at the participating medical centers. The sessions were implemented by a team of African American female health educators and had on average of 6 - 8 participants per session. The two study conditions are outlined below: