Lead Investigator: Donald Calsyn, Ph.D. Washington Node

1. HIV/STD SAFER SEX SKILLS GROUPS FOR MEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS • Lead Investigator: Donald Calsyn, Ph.D. Washington Node • Co-lead Investigator: Susan Tross, Ph.D. Long Island Node

2. Literature Reviews of Studies Demonstrating the HIV Prevention Effect of Drug Abuse Treatment • Metzger, D.S., Navaline, H. & Woody, G.E. (1998). Drug abuse treatment is AIDS prevention. Public Health Reports, 113(S1), 97-106. • Sorenson, J.L. & Copeland, A.L. (2000). Drug abuse treatment as an AIDS prevention strategy: a review. Drug and Alcohol Dependence, 59, 17-31.

3. Change in Seroprevalence of HIV among IDUs in and out of Drug Treatment in Philadelphia 1989-1991 33% 18% 15% 11% (n=152) (n=103) Metzger et al. 1993, JAIDS

4. Seroprevalence of HIV among IDUs in and out of Drug Treatment in Uppsala Sweden 1984 33% 3% Prior to 1979 (n=67) Blix & Gronbladh, 1991

5. Variables Correlated with the Sexual Behavior Effect Size in a Meta-Analysis of HIV Interventions in Drug Treatment • Non-minority samples r=0.72 • Use of separate sex sessions r=0.69 • Use of self control skills training r=0.59 • Peer group discussion r=0.67 • Number of techniques used r=0.63 • Use of didactic lectures r=0.59 • Condom distribution r=0.48 Prendergast et al, 2001, JCCP

6. Components of the Schilling et al. Skills Building Groups for Women Sessions 1-2. AIDS prevention and transmission, self identification of HIV risk, group discussion of barriers 3. Discussion of negative aspects of condoms, condom familiarity exercises, negotiation skills 4-5. Assertiveness training, problem solving, communication skills for safer sex, role plays of scripted scenarios and personalized scenarios

7. Session Outline for “Time Out! For Men” • Exploration of relationships • Challenging gender role stereotypes • Communications Skills (listening, conflict resolution, expressing feelings, assertiveness) • Sexual health and sexual functioning • Sexual responsibility in relationships • Making relationships work Bartholowmew & Simpson, 1996

8. Findings from “Time Out! For Men” Study Bartholowew et al, 2000, JSAT

9. Session Outline for “HIV/AIDS Update” • HIV information • HIV transmission risk behaviors • Risk reduction behaviors (injection and sexual) • Personal health protection rights • Assertiveness skills for HIV risk reduction • HIV testing Bartholomew & Simpson, 1994

10. Session Outline for “Project Light” • Group set up and HIV Information • Identifying HIV risk transmission triggers • Controlling triggers – Risk reduction problem solving, positive self talk • Condom skills, outercourse • Communication skills, assertive talk, creative negotiation, turning around what they say • Relapse prevention

11. Findings from “Project Light” * * *p<.001 NIMH Multisite HIV Prevention Trial Group, 1998, Science

12. Findings from “Project Light” * * *p<.001 NIMH Multisite HIV Prevention Trial Group, 1998, Science

13. Findings from “Project Light” * * *p<.001 NIMH Multisite HIV Prevention Trial Group, 1998, Science

14. Frequency of Combining Sex and Drugs as a Function of Treatment Status Males Females Calsyn et al, 1995, CPDD

15. Percent Rating Sex as More Pleasurable under the Influence of Drugs Frequency of Combining Sex & Drugs Males Females Calsyn et al, 1995, CPDD

16. Percentage of Males and Females Combining Drug Use with Most Recent Sexual Event Calsyn et al, 1999, CPDD

17. Increased Sexual Desire as a Function of Primary Drug of Abuse Rawson et al., 2002, JSAT

18. Improved Sexual Performance as a Function of Primary Drug of Abuse Rawson et al., 2002, JSAT

19. Enhanced Sexual Pleasure as a Function of Primary Drug of Abuse Rawson et al., 2002, JSAT

20. Sexual Infidelity as a Function of Primary Drug of Abuse Rawson et al., 2002, JSAT

21. Engaging in Unusual Sex Acts as a Function of Primary Drug of Abuse Rawson et al., 2002, JSAT

22. It Will Be Difficult to Separate Substance Use from Sexual Behavior Rawson et al., 2002, JSAT

23. Study Schema Advertise Study Availability  Consent to Screen for Inclusion/Exclusion & Screening Assessment  Obtain Informed Consent from Eligible Participants    Conduct Baseline Assessment    Randomly Assign 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

24. Inclusion / Exclusion Criteria Inclusion Criteria: • 1.Adult males in treatment at a participating CTP • 2. Self report engaging in unprotected vaginal or anal intercourse during the past 6 months. • 3.Agreeable to random assignment. • 4.Agreeable to completing 2-3 hour assessment battery at baseline, 2 weeks post intervention, three weeks post intervention, and six weeks post intervention. Exclusion Criteria: • 1.Observable, gross mental status impairment – including severe distractibility, incoherence or retardation • 2.Observable psychotic symptoms or severe psychiatric distress

25. Primary and Secondary Outcomes Primary Outcome Variable The number of unprotected vaginal and anal sex Secondary Outcome Variables Attitude towards condoms Possessing condoms Intent to use condoms Percentage of sexual events in which drug use occurred Frequency of “outer course” Gender role beliefs Number of sexual partners

26. HIV Education (Control Group) I. Group Introductions. Goals and Guidelines 5 Min II. IV. HIV/AIDS Update 15 Min III. HIV Risky Behaviors, injection practices 10 Min IV. HIV Risky Behaviors, sexual practices 10 Min V. Condom demonstration 10 Min VI. Healthy Options 10 Min

27. REMAS: Real Men are Safe 1. HIV/AIDS Update: Identifying Risks 2. HIV/AIDS Update: Planning Prevention 3. Sex without drugs. Can it happen? Is it Pleasurable? 4. Which Planets are Men and Women From? Exploring and Confronting Gender Stereotypes 5. Beyond the pick up line, communicating about sex

28. REMAS: Real Men are SafeSession 1 HIV/AIDS Update: Identifying Risks I. Group Introductions. Goals and Guidelines 10 Min II. Getting Started 10 Min III. HIV Risky Behaviors Exercise 15 MinIV. HIV/AIDS Update 15 Min V. HIV Risky Behaviors, injection practices 10 Min VI. HIV Risky Behaviors, sexual practices 10 Min VII. Condom demonstration 10 Min VIII. Revisit Risky Behaviors Exercise 10 Min

29. REMAS: Real Men are SafeSession 2 HIV/AIDS Update: Planning Prevention I. Welcome, redo introductions 5 Min II. Healthy options 10 Min III. Barriers to Condom Use 10 Min IV. Condom Practice 20 Min V. Identifying Triggers 25 Min VI. Risk Reduction Problem Solving 20 Min

30. REMAS: Real Men are SafeSession 3 Sex without drugs. Can it happen? Is it Pleasurable? I. Welcome, redo introductions 5 Min II. Experience with combining sex & drugs 40 Min Enhancements/Impairments III. Enhancing sex without drugs 25 Min IV. Coping with sexual impairment without drugs 20 Min

32. REMAS: Real Men are SafeSession 4 Which Planets are Men and Women From? Exploring and Confronting Gender Stereotypes I.Welcome, redo introductions 5 Min II. Challenging Stereotypes 30 Min III. Sexual Myths 20 Min IV. Unwritten rules 10 Min V. Responsibility in sexual relationships 25 Min

33. REMAS: Real Men are SafeSession 5 Beyond the pick up line, communicating about sex I. Welcome, redo introductions 5 Min II. Communicating about Safe Sex 20 Min III. Practice TALK 15 Min IV. Turning Around Partner Objections 20 Min V. Creative Negotiation 20 Min VI. Closing/Wrap-up 10 Min

34. Example of “Creative Negotiation” Exercise from Project Light James suspects that his wife may be seeing someone else on the side. But when he asked her about it, she denied it. He loves her and does not want to leave her, but he is very worried about AIDS and other STDs and wants to use condoms when they have sex. She has a bad temper, though, and is very jealous, so he is afraid to bring up the issue of sexually transmitted disease directly.

35. Example of “Creative Negotiation” Exercise from Project Light “My health care providers tell me that condoms may be the safest form of birth control for me. Other ways (the pill, IUD) can cause problems and may not be the best for your health. “ “The nurse at the clinic says that I have a problem with yeast infections. We keep passing it back and forth to each other. If we use condoms that won't happen and I can hopefully get rid of the infection. Sometimes it takes a long time to get rid of yeast infections, though.” Group discusses James's options.

36. Example 2 of “Creative Negotiation” Exercise from Project Light “Kareem has wanted to do Keisha for a long time. Finally, he gets together with her at a party and she seems really interested. They end up at his place and things move along until he takes out his condom and starts opening the package.”

37. Example 2 of “Creative Negotiation” Exercise from Project Light Keisha: You don’t need a condom, I’m on the pill Kareem: “Listen, I once got somebody pregnant that I didn't mean to, and now I'm just so nervous about having that happen again that I can't enjoy sex without knowing I'm secure by wearing a condom. Nothing's absolutely foolproof, not even the pill.” Keisha: “But it feels so much better without a condom.” Kareem: “Not for me, if I'm distracted worrying about pregnancy.” Keisha: “Well, okay, I guess.” What other strategies could Kareem have used?

38. HIV Risk Behaviors at 2 week Posttest for Women in Skill Building and AIDS Information Groups *p< .05 * * * * Schilling et al, 1991, Pub Health Reports

39. HIV Risk Behaviors at 15 Month Posttest for Women in Skill Building and AIDS Information Groups *p< .05 * * El-Bassel & Schilling 1992, Pub Health Reports

40. Sexual Enhancements Reported for the Most Recent Sexual Event in which Drugs Were Used Calsyn et al, 1999, CPDD

41. Sexual Impairments Reported for the Most Recent Sexual Event in which Drugs Were Used Calsyn et al, 1999, CPDD