HIV risk reduction interventions for women have been found to be effective at reducing rates of unprotected intercourse and number of sexual partners. However, alcohol use tends to interfere with the efficacy of HIV prevention interventions. Outcome studies of HIV reduction interventions have shown differential rates of effectiveness between using and non-using participants. Few studies have employed both alcohol use reduction and HIV prevention strategies for purposes of changing HIV risk behaviors. At present there are no randomized clinical trials focusing on HIV risk behaviors among women seeking help for alcohol problems; the latter comprises the target population of the proposed study. Three hundred and seventy-five women will be randomized to one of the following: HIV risk reduction (HIV-RR) consisting of HIV-related information and elements to increase motivation and behavioral skills necessary to reduce HIV risk behavior, or HIV information (HIV-1). HIV-RR was selected as the experimental intervention because it has demonstrated efficacy in reducing HIV risk behaviors in women. HIV-1 was selected as the control or comparison group because it is a typical intervention for HIV risk reduction in health care or specialty clinics. HIV-I provides general knowledge of HIV transmission but does not involve tailor-made feedback on risk reduction or skill building as in HIV-RR. All participants will first receive 8 Combined Behavioral Intervention (CBI) sessions regarding their alcohol use. CBI is a state-of-the art, empirically based treatment for addressing alcohol problems in dependent drinkers and is pertinent to the alcohol treatment needs of women. It is particularly important to provide an effective alcohol treatment to increase or maintain the potency of HIV-RR. Following the two-month CBI phase, participants will be reassessed on sexual risk behaviors and alcohol use. Following the reassessment (week 8), participants will be provided with 3 HIV-RR or HIV-1 sessions over three weeks. All participants will receive case monitoring for alcohol problems in the first fifteen minutes of each HIV session and 1 termination visit at week 12 (12th session). Participants will be assessed at 3, 6, 9, 12 and 15 months from baseline regarding sexual risk taking (e.g., frequency of unprotected sex) and alcohol use problems (e.g., percent days abstinent, drinks per drinking day, etc.). We hypothesize that women who receive HIV-RR and who respond favorably to alcohol treatment will fare better than their counterparts in HIV-1. Data generated from the study will inform development of future combined alcohol and HIV risk reduction interventions.
| Zweben, Allen; Fucito, Lisa M; O'Malley, Stephanie S (2009) Effective Strategies for Maintaining Research Participation in Clinical Trials. Drug Inf J 43: |
