HIV/STD SAFER SEX SKILLS GROUPS FOR MEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS (CTN 0018)

1. HIV/STD SAFER SEX SKILLS GROUPS FOR MEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS (CTN 0018) • Lead Investigator: Donald Calsyn, Ph.D. Washington Node • Co-lead Investigator: Susan Tross, Ph.D. Long Island Node • Project Managers: Sara Berns, Ph.D./ Mary Hatch-Maillette, Ph.D. • Supported by NIDA (1 U10DA13714-01, Dennis Donovan, PI)

2. Treatment Sites Red=PsychosocialOutpatient Black=Methadone Maintenance Seattle Norwalk Hartford Staten Is. Philadelphia (x2) Toledo Huntington San Francisco Greensboro Raleigh Richmond Santa Fe Rancho Cucamonga

3. Study Schema Advertise Study Availability  Consent to Screen for Inclusion/Exclusion & Screening Assessment Obtain Informed Consent from Eligible Participants  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

4. Inclusion / Exclusion Criteria & Screening Measures 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 assessment battery at baseline, 2 wk., 3 mo., & 6 mo. post intervention. Exclusion Criteria: • 1.Observable, gross mental status impairment – including severe distractibility, incoherence or retardation • 2.Observable psychotic symptoms or severe psychiatric distress • 3. Having a primary partner planning to become pregnant. Screening Measures: • 1.Demographic Form • 2.RiskBehavior Survey • 3. Mini Mental Status Exam < 25

5. Primary and Secondary Outcomes Primary Outcome Variable Number of unprotected vaginal & anal sex events 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

6. Measures Baseline: • ASI-Lite, CIDI • Sexual Behavior Interview (ACASI) • Condom Barriers Scale • Sexual Self-efficacy • Condom Skills Demonstration • Bem Sex Role Inventory • Intervention Exposure Checklist

7. Measures Follow Up: • ASI-Lite D&A (at 6 month only) • RBS (injection only) • Sexual Behavior Interview (ACASI) • Condom Barriers Scale • Sexual Self-efficacy • Condom Skills Demonstration • Bem Sex Role Inventory • Intervention Exposure Checklist

8. HIV Education (Control Group) I. Group Introductions. Goals and Guidelines 5 Min II. HIV/AIDS Update 10 Min III. HIV Risky Behaviors, injection practices 5 Min IV. HIV Risky Behaviors, sexual practices 10 Min V. Healthy Options 10 Min VI. Condom demonstrations 10 Min VII. Overcoming Barriers to Condom Use 10 Min

9. Techniques Utilized in the HIV Education Group Lecture Information on Flipcharts Condom Demonstrations

13. 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. Beyond the pick up line, communicating about sex 5. Communicating about Safe Sex II. Workshop Summary

14. Techniques Utilized in the REMAS Group Lecture & Discussion Information on Flipcharts Condom Demonstrations& Practice Brainstorming & Discussion Self Assessment Exercises Role Plays

15. Information, Motivation, Behavioral Skills Model & Techniques Utilized in REMAS Information Lecture & Information on Flipcharts Condom Demonstrations Motivation Self Assessment Exercises Brainstorming & Discussion Behavioral Skills Role Plays Condom Practice Brainstorming

17. Role Play Example:Running into a friend of friend still using JESSICA: Paul, do you remember me? We met at your friend Dave’s place a few months ago. We had a wild time. Dave had gotten some great stuff. What you been doing? PAUL: I’m in treatment now. I haven’t done any [crack/coke/crystal] for over a month now. I am just starting to feel normal again. JESSICA: I was in treatment once. I missed the excitement though. I try not to do so much anymore, but I still like to get high. I am on my way over to Dave’s right now to party. Dave called and said he has some killer stuff. Want to join me? PAUL: No thanks. I’m sticking to my program. I can get way out of control on that stuff. JESSICA: I remember the last time I saw you at Dave’s. It looked like you and that woman you were with were having a great time. I could show you an even better time. I know I’ll get all sexed up once I get high. PAUL: I’m sure you could show me a good time, and I get very horny when I do [crack/coke/crystal] also. The sex use to be good, but after awhile, I had trouble getting off. Then I got paranoid. I’m committed to staying straight. I need to get going.

18. Role Play Example Continued:Running into a friend of friend still using JESSICA: Paul when was the last time you got laid? You don’t need to do any [crack/coke/crystal]. Just come for the sex. I’m getting all turned on just thinking about it. Come join me. PAUL: There is no way I can be around other people getting high and not use myself. It has been awhile since I have had sex, but that’s OK. I like being straight and am not willing to start using again just to have sex. JESSICA: Good for you. I’m not ready to stop using now. I’m off to get high. See you later. PAUL: I’m sure that down the road some sexual opportunities will come my way that do not include getting high. Who knows, maybe even we could get together if you decide to do recovery again.

19. Sex under the Influence is Common for Substance Abuse Treatment PatientsCalsyn, Hatch-Maillette, Doyle, Cousins, & WoodyTuesday, Board 38 • The majority of sexually active men in methadone maintenance (82.8%) and psychosocial outpatient treatment (65.3%) reported engaging in sex under the influence of drugs or alcohol in the 90 days prior to baseline assessment. • Both MM and OPS patients were more likely to have a casual sexual partner at the last sexual event if they were under the influence. • OPS patients under the influence compared to those not under the influence at last sexual event were more likely to engage in anal sex and insertive oral sex.

20. Sexual Activity of Substance Abuse Treatment PatientsHatch-Maillette, Calsyn, Doyle, Woods, Coyer, Sillo, WoodyTuesday, Board 33 • Patients in psychosocial outpatient treatment reported significantly more frequent vaginal and insertive oral sex with their main partner, and with other female partners in the prior 90 days compared to methadone maintenance patients. • Men who were stimulant users had more partners and their partners were riskier (χ2=4.6, p=.03), compared to primarily non-stimulant users.

21. Communication about condom use and reported condom use among participants enrolled in drug treatmentSong, Calsyn, Doyle, Herr, & SorensenTuesday, Board 32 • Positive attitudes about condoms, communication with female partners about sex and condom use, possessing condoms, and not being married were associated with greater condom use for vaginal and anal intercourse. • Participants who perceived condoms as being more accessible were more likely to use condoms for vaginal and anal intercourse • Participants in MM were more likely to communicate with their female partners about their sex life and condom use then those in OPS programs.

22. Screening, Baseline & Randomization No Contact 100% condom use other Other Withdrew Pregnancy Planned Left Tx No sex Randomized Eligible MMSE < 25

23. Sample Demographics IneligibleRandomized m (sd) m (sd) Age42.5 (10.2) 39.5 (10.4) Racen (%) n (%) White 179 (54.9)342 (58) Af. Am. 89 (27.3) 165 (28) Hisp. 43 (13.2) 66 (11.2) other 15 ( 4.6) 17 ( 2.9)

24. Sample Demographics: Randomized m (sd) Education12.3 (1.9) Income$519.79 (1178.49) Maritaln (%) Never 278 (47.2) Married 112 (19) Div/Wid/Sep 199 (33.8)

25. Recruitment by Site Total n=594

26. Treatment Exposure HIV-ED REMAS 56.57% 51.56%

27. Follow Up Rates

28. Male condom skill list • Chose a latex condom • Chose a water-based lubricant • Expiration date on package is checked • Package is opened carefully • Condom checked for damage • Determined direction in which condom rolls • Condom rolled correctly downward • Condom rolled to base of penis • Air removed from condom • Space left at tip of condom • Lubricant added to inside tip of condom or penis • Turned to the side and withdrew condom • Took care to avoid spilling • Tied off condom and disposed of in trash

29. Female condom skill list • Expiration date on package is checked • Package is opened carefully • Condom checked for damage • Condom unrolled and the two rings separated • Condom rubbed gently to evenly spread the lubricant • Inner ring squeezed between fingers • Inner ring pushed into vaginal canal while squeezed • Inner ring placed against cervix so that it is completely covered • Outer ring covers outside of vagina • End of condom is twisted and removed by pulling, with care taken not to spill its contents • Condom disposed of in a trash can

30. Change in condom skills as a function of intervention attendance ♂condoms ♀condoms Ptime<.001 Ptime x attendance<.001

31. Condom use for most recent sexual event at post intervention as a function of intervention attendance Low risk High Risk

32. Lead Node Team Mary Hatch-Maillette QA & Regulatory Sara Berns Anthony Floyd Data Management Donna Bargoil Molly Carney Research Assistant Katie Weaver Viki Stanmour Brooke Leary Statistician Michael Dudley Suzanne Doyle TrainingWA Node Coordinator John Baer Brenda Stuvek

33. RRTC and Site PIs Yong Song Genise Lalos Paul Crits-Christoph Judy Harrer Stephen Weinstein Ross Chaban Bob Sterling Allen Cohen Bill Daly Michael McCann Susan Tross Louise Haynes Julie Matthews Therese Killeen Sam Ball Diane Pallas Tad Clodfelter Ron Jackson Jackie Butler Kristie Smith Charlotte Royer-Malvestuto Jennifer Manuel Tamara Owens

34. Site Coordinators Esther Ricardo-Bulis Jenifer Skelding Sarh Pelta Parrish Harless Kerry Raively Gina Richardson Mark Hirschman Kimberly Pressley Bonita Sussman Al Woods Lisa Markiewicz Diane Pallas Allison Hartsock Lester Fleming Nicole Moodie

35. Research Assistants Rhodri Dierst-Davies Tracey Vann Ellen Fritch Steve Rosebrook Carolyn Laurenza Tara Lee Diane Losardo Scott Herr Brian Smith Aaron Upton Sarah Cousins Charles Michael Beverly Holmes Dennis Romero Brianne O’Sullivan Clark Reed Diana Pacheco Melissa Clymer Patrick Worhunsky Denise McRae Barbara Hobbs

36. Therapist Supervisors Yong Song Susan Coyer Mark Hirschman Al Woods Henry Bates Deborah Service Evette Wilson Louise Haynes Joe Grossman Michael DeBernardi Sarah Sperrazza Carol Davidson David Hettich Melodie Keen Lester Quagliano

37. Therapists William Buehlman Max Mineo Luis Ramos Dennis Durant Jerome Wells Bernie Reardon Joel Hurdle Donald Bellemore Charles Holman Will Pescock Philip Pellegrino George Cantees Patrich Walsh Fred Clark Arthur Sagevick Jimmy McKeller Richard Dable Louis Battistone Frank Shimko Nick Nardone Jimmy Moutinho Ulysses Rogers Markel Pitt Andre Walker Quincy Stephens Art Panero Doug Stenchever Stefan Dobuszynski John Williams