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Increased exposure to an HIV risk reduction protocol associated with a reduction in drug abuse severity 1 Haynes ; 1 Carter ; 1 Herrin ; 2 Calsyn Louise F. Rickey E. Amy E. Donald A. 1Medical University of South Carolina, Southern Consortium Node; 2University of Washington, Washington Node, NIDA Clinical Trials Network Results Introduction and Hypotheses Previously, we reported that men in substance abuse (SA) treatment randomized to a five-session HIV prevention intervention reduced their sexual risk more than men randomized to a single-session intervention. For the purpose of this research, the association of the number of HIV prevention sessions attended with reductions in risky sexual behavior (RSB) and ASI composite scores was examined for those participants randomized to the five-session intervention. Specifically, the following hypothesis was tested: Table 1 presents the sample description of the N=89 participants included in this analysis. The majority (80%) reported engaging in risky sexual behavior at baseline. A total of 20 (22%) of the included subjects failed to attend any REMAS sessions, 35% attended all five sessions, and the remaining 43% attended one to four sessions. Table 2 presents the baseline drug and alcohol use profiles of the sample at baseline. Variable Age (years) Hypothesis: Participants who reduce their drug use will be more likely to reduce risky sexual behavior and that the number of HIV prevention sessions attended would enhance the effect. Figure 1 illustrates the baseline and three-month mean number of RSB events and ASI-Lite composite scores. Figure 2 dichotomizes each of these variables to represent the percentage of subjects that improved over the course of follow-up by the number of sessions attended. Risky Sexual Behavior (any in past 30 days reported at baseline) {a} Measures SA measures were the alcohol (ALC) and drug (DRG) composite scores from the ASI-Lite. Risky sexual behavior (RSB) was defined as the number of vaginal and anal intercourse acts without a condom, and the outcome for this analysis was the change in RSB at three month follow-up relative to baseline. A participant was considered to have improved if there was a reduction in RSB at the three month follow-up. Mean (SD) Methadone Treatment Ethnicity Hispanic American Indian or Alaskan Asian Black White 10 2 1 25 51 71 11.24 2.25 1.12 28.09 57.3 79.78 Table 1: Sample description (n=89) {a} Risky Sexual Behavior is defined as the number of vaginal and anal intercourse acts without a condom The odds for an improvement in RSB (i.e., 40 0.40 reduction in RSB events) at follow-up 30 0.30 significantly increased as the number of sessions attended increased (p=0.032). In 0.20 20 addition, the odds for a reduction in the DRG composite score similarly increased 10 0.1 with session attendance (p=0.049), yet this association did not mediate the effect of 0.0 0 Baseline 3 month follow-up the number of sessions on RSB. The RSB ASI-DRG ASI-ALC number of REMAS sessions was not found to be associated with a reduction in ALC Figure 1: Mean (SD) number of RSB events and composite scores (p=0.66). ASI-Lite composite scores (n=89). The SD for RSB is 60.94 at baseline and 39.4 at three-month follow-up. 100% 90% Baseline Use D1 Alcohol D2 Alcohol (to intoxication) D3 Heroin D4 Methadone (presribed) D4a Methadone (illicit) D5 Other Opiates/Analgesics D6 Barbiturates D7 Sedatives/Hypnotics/Tranquilizers D8 Cocaine D9 Amphetamines D10 Cannabis D11 Hallucinogens D12 Inhalants D13 More than 1 substance per day Lifetime (years) Mean SD 4.28 1.84 0.74 16.38 0.07 1.60 0.00 3.57 2.81 0.32 3.55 0.06 0.01 10.63 11.07 7.33 6.96 1.91 0.11 2.42 0.54 1.58 6.10 2.66 9.45 0.82 0.38 12.53 Composite Scores, mean (SD) ALC DRG 8.27 4.51 2.29 14.91 0.33 5.80 0.00 8.71 6.42 1.09 7.73 0.38 0.11 12.69 11.17 9.35 9.08 3.26 0.53 5.26 2.11 3.96 7.48 4.65 9.65 2.07 1.93 10.62 0.13 (0.20) 0.19 (0.14) Table 2: ASI-Lite Drug and Alcohol Use at Baseline Conclusions 0.50 50 These data suggest that an overall reduction in RSB and DRG was associated with increased exposure to the REMAS intervention. A limitation of this analysis is that it only examines correlations among patients who self-selected the amounts of their REMAS exposure, so any suggestion of causality would be speculative. Another limitation is the possible confounding. Men who attended more sessions would have been exposed to additional substance abuse treatment. This could cause the ASI improvements. Further research is needed to examine if reductions in RSB are linked to reductions in incident cases of HIV and other STDs and to better understand the potential confounding effects of a participants willingness to remain in treatment since those who attended more sessions may have been more highly motivated to change than those who did not attend as many sessions. 80% % Improved 70% Statistical Considerations Binary indicator variables were created to indicate improvement in RSB, ALC and DRG. Improvement was defined as a decrease in scores at three-month follow-up compared to baseline. Logistic regression was used to model the log odds of improvement in each measure as a function of the number of sessions attended. To assess if reductions in DRG mediated the effect of the number of sessions attended on RSB improvement, a multiple logistic model was considered. % 38.1 (10.3) ASI Composite Scores Participants Of the 291 men randomized into the Real Men Are Safe (REMAS) intervention, this analysis focuses on the n=89 who had both baseline and three-month follow-up assessments and who reported having more than one sexual partner during the period six months prior to and throughout the study. n # of RSB events Methods Level Past 30 days Mean SD References 60% 50% 40% 30% 20% 10% 0% 0 (n=20) 1 (n=10) 2 (n=6) 3 (n=5) 4 (n=17) 5 (n=31) 1. Calsyn, Donald A.; Hatch-Maillette, Mary; Doyle, Suzanne R; Berns, Sara; Crits-Cristoph, Paul; Song, Yong S; Harrer, Judith M; Lalos, Genise. “Efficacy of a Gender Specific HIV Prevention of Men in Substance Abuse Treatment.” Poster presented at the XVI International AIDS Society (IAS) Conference, Toronto, Canada, August 13-18, 2006. 2. Calsyn Donald A et al. “Primary Results from CTN Safer Sex Skills Groups for Men”. Symposium XVII at The College of Problems of Drug Dependence (CPDD) Conference, Quebec City, Quebec, Canada, June 15-21, 2007. # Sessions Attended RSB ASI-DRG ASI-ALC Acknowledgements Figure 2: Percent of subjects that improved by number of sessions attended (n=89) *Note: Improvement is defined as a decrease in the number of RSB events or a decrease in the ASI-DRG and ASI-ALC scores at three-month follow-up compared to baseline This study is funded by the following grants from the National Institutes of Health: DA013727, DA013714. The consortium performing this study was a part of the Clinical Trials Network (CTN) established by the National Institute on Drug Abuse (NIDA).