HIV/STD safer sex skills groups for women in methadone maintenance or [psychosocial outpatient treatment: A NIDA Clinical Trials Network trial.

Since women in high drug use communities are among the fastest growing groups with AIDS, sexual risk reduction interventions for drug-using women is a public health imperative. A randomized controlled trial of evidence-based, gender-specific HIV/STD safer skills building (SSB) group versus standard HIV/STD education (HE) was conducted with women in 12 community drug treatment programs in NIDA?s Clinical Trials Network (protocol CTN-0019). Based on social cognitive learning theory and empowerment theory, SSB consisted of 5 group sessions, using problem solving, skill rehearsal and peer support to increase HIV/STD risk awareness/skills, especially condom use and partner negotiation. As previously reported, reduction in the primary outcome, frequency of unprotected (vaginal or anal) sexual occasions (during the prior 3 months), was observed in both conditions at 3 months; however, at 6 months, whereas this decline held in the SSB condition, there was an increase in the HE condition, reflecting a significant time by intervention condition difference (F=67.2, p<.0001). Intervention effects on the secondary outcomes, of carrying condoms (versus not) and perceived self-efficacy to use condoms, will be presented. For both analyses, 515 women were included in intention-to-treat mixed effect modeling. A significant Intervention X Time effect was obtained in probability of carrying a condom ? with the SSB group showing a significant increase in probability at 3 months (F=8.58, p<.004) and at 6 months (F=4.98, p<.03), as compared to the HE group, for whom these probabilities were unchanged. The Intervention X Time effect for self-efficacy to use condoms only obtained a trend toward significance at 6-months (F=3.6, p<.06). The implications of these findings for conceptualizing behavior change achieved during sexual risk reduction intervention among drug-using women will be discussed. The finding of a significant intervention effect, favoring the SSB condition, on carrying condoms provides support for the effect previously reported for the primary outcome of frequency of unprotected sexual occasions. The finding of an only trend-level intervention effect on perceived self-efficacy to use condoms raises some question about the influence of this construct in the behavior change observed.

Related protocols: CTN-0019