1. Efficacy of a gender specific HIV prevention for men in substance abuse treatment D.A. Calsyn 1,2, M. A. Hatch-Maillette 2, S.R. Doyle 2, S. Berns 2, S. Tross 3, P. Crits-Christoph 4, Y. Song 5,6, J.M. Harrer 7, G. Lalos 8, 1 University of Washington (UW) School of Medicine, 2 UW Alcohol & Drug Abuse Institute, 3 Columbia University, 4 University of Pennsylvania, 5 University of California San Francisco, 6 Veterans Affairs Medical Center San Francisco, 7 University of Cincinnati, 8 Prestera Center

2. Abstract Objective: Compare the efficacy of a five session (over 3 weeks) gender-specific HIV prevention group intervention (Real Men Are Safe, REMAS), with a single-session HIV education group intervention (HIV-Ed). Methods: Sexually active men in substance abuse treatment who volunteered for the study were randomly assigned to attend either REMAS or HIV-Ed. Sexual risk assessments were conducted via audio computerized assisted interview at baseline and post intervention. This report focuses on condom use during most recent sexual event from the 2-week post assessment. Three attendance groups were identified (attended HIV-Ed, attended 3 or more REMAS sessions, attended no sessions (NS)). Attendance group served as the independent variable and baseline condom use at most recent sexual event served as the covariate. The data analyses were conducted separately for men in low risk (monogamous longer than six months) and high risk (casual partners, multiple partners or a short duration monogamous) relationships. Results: In logistic regression models REMAS attendance was positively related to engaging in safe sex during the most recent sexual event at the 2-week post assessment for the high risk participants, but not for the low risk participants. For high risk individuals the odds of condom use at the post- intervention assessment were 6.67 (p=.002) for REMAS compared to NS, and 2.45 (p=.05) compared to HIV-Ed. For high risk participants the change in percent of subjects using condoms for most recent sexual event from pre to 2-week post assessment was: REMAS, 13.73% to 50.0%; HIV- Ed, 17.74% to 34.92%; NS, 16.28% to 16.67%. Conclusion: Attendance at a 5 session gender specific HIV prevention intervention for men involved in high risk sex who were attending substance abuse treatment was related to a greater likelihood of safe sex than associated with non-attendance or attendance at a single session HIV Education group.

3. Background Prendergast et al. (2001) conducted a meta-analysis of substance abuse treatment-based HIV risk reduction interventions and found significant support for their efficacy. Of particular interest were the findings that intensity of the intervention (i.e., number of sessions) and the use of separate sessions for male and female subjects moderated the overall positive effects. Gibson et al. (1998) had previously observed similar effects of enhanced education. These findings, plus the results of the Project Light HIV prevention intervention (NIMH Multisite HIV Prevention Trial Group, 1998), that compared single and multi-session HIV education interventions, contributed to the design of the current study that evaluated the effectiveness of a gender specific single session HIV education intervention with a more intense, 5 session intervention.

4. Background (cont.) The two therapy conditions are described briefly in Tables 1 & 2. The HIV Education condition (control) is a 60 minute didactic presentation developed to represent what most substance abuse treatment programs provide in the way of HIV prevention (Table 1). Real Men Are Safe (REMAS, experimental) is composed of five 90-minute sessions covering the topics listed in Table 2. Table 3 lists the different techniques used within the two conditions. Previous research has indicated individuals with a monogamous low risk primary partner are less likely to adopt safe sex behaviors (e.g. condom use) than individuals with multiple or high risk partners (Gossop et al., 2002; Rosengard et al., 2004). References. Gibson, D.R., McCusker, J. & Chesney, M. (1988). Effectiveness of psychosocial interventions in preventing HIV risk behaviour in injection drug users. AIDS, 12, 919-929. Gossop, M., Marsden, J., Stewart, D. & Treacy, S. (2002). Reduced injection risk and sexual risk behaviours after drug misuse treatment: results from the National Treatment Outcome Research Study. AIDS Care, 14, 77-93. Prendergast, M.L., Urada, D. & Podus, D. (2001). Meta-analysis of HIV risk-reduction interventions within drug abuse treatment programs. Journal of Consulting and Clinical Psychology, 69, 389-405. Rosengard, C., Anderson, B. & Stein, M. D. (2004). Intravenous drug users’ HIV risk behaviors with primary/other partners. Am J Drug & Alc Abuse, 30, 225-236. The NIMH Multisite HIV Prevention Trial Group (1998). The NIMH Multisite HIV Prevention Trial: Reducing HIV Sexual Behavior Risk. Science, 280, 1889-1894.

5. Table 1: HIV Education Outline (Control Group) I. Group Introductions. Goals and Guidelines 5 Min II. HIV/AIDS Update10 Min III. HIV Risky Behaviors, injection practices 5 Min IV. HIV Risky Behaviors, sexual practices10 Min V. Healthy Options 10 Min VI. Condom demonstration 10 Min VII. Overcoming Barriers to Condom Use10 Min

6. Table 2: Real Men are Safe (REMAS) Outline 1. HIV/AIDS Update: Identifying Risks 90 Min 2. HIV/AIDS Update: Planning Prevention 90 Min 3. Sex without drugs. Can it happen? Is it pleasurable? 90 Min 4. Beyond the pick up line, communicating about sex 90 Min 5. Communicating about Safe Sex II. Workshop Summary 90 Min

7. Table 3: Techniques Utilized in the HIV Education & REMAS HIV Education Lecture Information on Flipcharts Condom Demonstrations REMAS Lecture & Discussion Information on Flipcharts Condom Demonstrations & Practice Brainstorming & Discussion Self Assessment Exercises Role Plays

8. Methods Subjects. Men enrolled in one of 14 substance abuse treatment programs across the US were recruited to take part in an HIV/STI prevention project specifically tailored for men (NIDA Clinical Trials Network Protocol 0018). Inclusion criteria included age of 18 or more, engagement in unprotected vaginal or anal intercourse in the prior 6 months, willingness to attend HIV/STI prevention groups and complete assessments at baseline and at 2 wk., 3 mo., 6 mo. post intervention. Exclusion criteria included having a primary partner planning to get pregnant or a Mini Mental Status Exam < 25. Of the 1002 men screened for participation 660 met study inclusion criteria. Primary reasons for exclusion were either an absence of sexual activity or condom use 100% of the time for vaginal and/or anal sex. Primary reason eligible participants were not randomized was loss of contact, usually reflecting leaving treatment. This report focuses on the 286 (48.1%) of 594 participants randomized to an intervention condition who either 1) attended the HIV education control intervention, or 2) attended 3 or more sessions of the REMAS intervention, or 3) attended no sessions of either intervention, and who completed assessments at baseline and post intervention. Demographics for the sample are provided in Table 4.

9. Table 4: Sample Demographics

10. Methods (cont.) Procedures. The study schema is presented in Figure 1. This report focuses on the last sexual event described by participants at the baseline and 2 week post intervention assessment if that event happened within 90 days of baseline assessment, and after the participant was scheduled to attend their first intervention group session for the post intervention assessment. The description of the last sexual event was collected as part of the Sexual Behavior Inventory (SBI), an extensive structured interview concerning sexual behavior that was administered via audio computer assisted interview (ACASI) methodology. The session attendance rates are provided in Figure 2. For the logistic regression analyses three attendance groups are defined: attended no sessions, attended the HIV-Education session, attended three or more REMAS sessions. Defining REMAS completion as attending 3 or more sessions was based on the investigators a priori clinical experience that exposure to 3 or more REMAS sessions would be sufficiently different from exposure to the control condition to warrant including them in a post hoc “completer analysis” of the primary outcome variable. This definition is similar to that used in Project Light” in which attendance at 5 or more of 7 experimental sessions was defined as completing. Engagement in safe sex during the last sexual event was defined as using a condom for vaginal and/or anal intercourse or engaging in non-penetrative sexual activities such as mutual masturbation.

11. Figure 1: Study Schema Screening  Conduct Baseline Assessment → Place in Waiting Cohort  Randomly Assign Cohort to Intervention   Standard HIV Education Gender Specific Intervention (one session) (five sessions)   Conduct Post Intervention Assessment  Conduct Three Month Follow Up Assessment  Conduct Six Month Follow Up Assessment

12. Figure 2: Treatment Exposure REMASHIV-ED 51.56% 56.57%

13. Methods (cont.) Data Analysis. Since the no attendance (78.2%), the HIV-ED (78.6%) and REMAS (78.2%) groups did not differ on the percent sexually active between the start of the intervention and the two week post intervention assessment, the primary data analysis focused only on those meeting the sexually active criteria listed above. Engagement in safe sex during the last sexual event and engaging in sex under the influence of drugs or alcohol as measured at the 2 week post assessment served as dependent measures in two separate logistic regression analysis. Engagement in safe sex during the last sexual event and engaging in sex under the influence of drugs or alcohol as measured at the baseline assessment served as covariates in the logistic models. Independent variables in the models were two design variables representing attendance at the HIV Ed group or no attendance at any intervention session, with attendance at 3 or more REMAS sessions serving as the comparison group. The analyses were conducted separately for those who at baseline were identified as engaging in low risk sexual behavior (monogamous with a partner for longer than six months who is not known to be HIV positive or involved in commercial sex work) and those at high risk (multiple partners, having an HIV positive partner, having a commercial sex work partner or a monogamous partner of less than six months duration, or a monogamous partner who is identified as a casual partner).

14. Results 1.Engaging in sex under the influence of drugs or alcohol during the last sexual event described at the post intervention assessment did not differ across intervention attendance groups in the logistic regression models. 2.Engaging in safe sex during the last sexual event described at the post intervention assessment did not differ across intervention attendance groups in the logistic regression models for those who were at low sexual risk at the baseline assessment. 3.Men at high sexual risk attending 3 or more sessions of the REMAS intervention were significantly more likely to engage in safe sex during the last sexual event described at the post intervention assessment than men attending no sessions (odds ratio = 6.67, p=.002). 4.Men at high sexual risk attending 3 or more sessions of the REMAS intervention were significantly more likely to engage in safe sex during the last sexual event described at the post intervention assessment than men attending the single HIV- Education session (odds ratio = 2.45, p=.05). 5.Presented in Figure 3 are the percent engaging in safe sex at the most recent sexual event described at both the baseline and two week post intervention assessment as a function attendance group and sexual risk behavior at baseline assessment.

15. Figure 3: Engaging in safe sex during the most recent sexual event as a function of intervention attendance Low Sexual RiskHigh Sexual Risk * # * REMAS >HIV-Ed (OR=2.45, p=.05) # REMAS >No Attendance (OR=6.67, p=.002)

16. Conclusions  For men engaging in high risk sexual behavior, attendance at a gender specific HIV prevention intervention during substance abuse treatment was related to a greater likelihood of engaging in safe sex behavior at the most recent sexual event than with non-attendance or attendance at a single session HIV Education group.  Attendance at a gender specific HIV prevention intervention for men in substance abuse treatment was not related to a decreased likelihood of engaging in sex under the influence of drugs or alcohol at the most recent sexual event as compared with non-attendance or attendance at a single session HIV Education group.

17. Acknowledgements The Washington Node of the Clinical Trials Network are supported by NIDA (U10DA13714-01, Dennis Donovan, PI). The authors wish to thank the:  CTN 0018/0019 lead node teams,  the 23 RRTC and site PIs,  the 15 site coordinators,  the 21 research assistants,  the 15 therapy supervisors and,  the 29 therapists who worked on this project.

18. Clinical Trials Network ∙ Dissemination Library National Drug Abuse Treatment A copy of this presentation will be available electronically after the meeting from the: http://ctndisseminationlibrary.org CTN Dissemination Library