1. Dr. Calsyn has no conflicts of interest to report for this workshop presentation

2. Gender Specific Sexual Risk Reduction Interventions for Men and Women Workshop at the 2009 Clinical Practices Research Symposium June 3, 2009 Portland, Oregon Donald Calsyn, Ph.D., Washington Node of the CTN, Alcohol & Drug Abuse Inst., University of Washington

3. Presentation Plan Rationale for men’s and women’s protocols Study design “Real Men Are Safe” description “Safer Sexual Skills Building” description Differences between the two interventions Main findings “Real Men Are Safe” Main findings “Safer Sexual Skills Building” “Real Men Are Safe” demonstration “Safer Sexual Skills Building” demonstration

4. Background HIV Risk Behavior  Engagement is substance abuse treatment is associated with reduction in HIV risk behaviors.  However, many men and women in treatment continue to engage in high risk sexual behavior while in treatment. HIV Prevention in SA Treatment  Most treatment programs provide a one hour HIV/AIDS prevention limited to providing information only.  Meta analyses indicate the more efficacious HIV prevention interventions utilize:  Separate sessions for ♂ / ♀,  Condom demonstrations,  Skills training exercises,  Peer group discussions,  A variety of techniques

5. Background-Women Heterosexual women are among the fastest growing subgroups of people with AIDS in the US While female AIDS cases due to injection drug use have declined (32%), cases due to heterosexual transmission have increased (66%) Partner risk factors in heterosexual transmission: partner that is an IDU (19.8%) Race/Ethnicity of AIDS cases: Black (59.5%); White (20.2%); Latina (19.1%)

6. Purpose  Assess the effectiveness of an HIV risk reduction intervention for women in substance abuse treatment in multiple community treatment programs that had been shown to be efficacious previously in a single site  Develop an HIV sexual risk reduction interventions for men to serves as a companion research protocol to the CTN approved protocol for women.  Incorporate into the interventions elements shown to be efficacious previously, and consistent with current theories on HIV risk reduction interventions.  Compare the effectiveness of the developed interventions (“Safer Sex Skills Building” and “Real Men Are Safe”) to a standard HIV prevention intervention typically provided in substance abuse treatment settings.

7. Treatment Sites Seattle San Francisco (18) Hartford Philadelphia (x2) Staten Is. High Point Norwalk (18) Rancho Cucamonga (18) Santa Fe (18)Columbia Toledo Huntington Raleigh Red=Psychosocial Outpatient Black=Methadone Maintenance......... La Puente (19) Raleigh (19).

8. Inclusion / Exclusion Criteria & Screening Measures Inclusion Criteria: 1. Adult men or women 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. Risk Behavior Survey 3. Mini Mental Status Exam < 25

9. 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 Sex under the influence of drugs or alcohol Number of sexual partners

10. Study Design - RCT Baseline Assessment Eligibility Health/HIV Education (1 Session) Safer Sex Skills Building or Real Men Are Safe (5 Session) Cohort Randomization 3 Month FU 6 Month FU Post Treatment

11. Real Men Are Safe Description Donald Calsyn, Ph.D. and the CTN0018 protocol team

12. Intervention Source Materials for “Real Men Are Safe” Time Out! For Men: A communication skills and sexuality workshop for men Bartholomew, N.G., & Simpson, D.D. (1996). Approaches to HIV/AIDS education in drug treatment Bartholomew, N.G. & Simpson, D.D. (1992). Available at www.tcu.ibr Institute for Behavioral Research, Texas Christian Univ. Project Light Intervention Manual The NIMH Multisite HIV Prevention Trial Group

13. Anything Missing ?

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

15. Sex under the influence of drugs or alcohol Sex Under the Influence 0 10 20 30 40 50 60 70 80 90 100 Last 90 DaysLast Sexual Event Percent Baseline 3 Months 6 Months

16. Temptation to Use Drugs or Alcohol to Meet Sexual Needs / Desires

17. HIV Education (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 demonstrations 10 Min VII. Overcoming Barriers to Condom Use10 Min

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

22. 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

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

24. REMAS: Real Men are Safe Session 1 HIV/AIDS Update: Identifying Risks I. Group Introductions. Goals and Guidelines10 Min II. Getting Started10 Min III. HIV Risky Behaviors Exercise 15 Min IV. HIV/AIDS Update15 Min V. HIV Risky Behaviors, injection practices10 Min VI. HIV Risky Behaviors, sexual practices10 Min VII. Condom demonstration10 Min VIII. Revisit Risky Behaviors Exercise10 Min

25. HIV RISK BEHAVIOR CARDS Abstinence from sex or drugs Massage/ body- to-body rubbing Kissing Solo or Parallel Masturbation Using vibrators and sex toys Shooting drugs with a new syringe Mutual masturbation Grinding Oral sex with a barrier Vaginal sex with a condom Anal sex with a condom Oral sex with a condom Cleaning injection equipment with bleach Vaginal sex without a condom Anal sex without a condom Shooting up second/sharing works/needles

26. REMAS: Real Men are Safe Session 2 HIV/AIDS Update: Planning Prevention I. Welcome, redo introductions 5 Min II. Healthy options 10 Min III. Barriers to Condom Use20 Min IV. Condom Practice 25 Min V. Identifying Triggers15 Min VI. Risk Reduction Problem Solving15 Min

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. REMAS: Real Men are Safe Session 3 Sex without drugs. Can it happen? Is it Pleasurable? I. Welcome, redo introductions 5 Min II. Personalizing Commitment to Sexual Safety15 Min III. Experience with combining sex & drugs Enhancements/Impairments35 Min IV. Enhancing sex without drugs 20 Min V. Coping with sexual impairment without drugs 15 Min

31. REMAS: Real Men are Safe Session 4 Beyond the pick up line, talking about sex with partners I. Welcome, redo introductions 5 Min II. Challenging Stereotypes20 Min III. Unwritten rules 10 Min IV. Responsibility in sexual relationships 20 Min V. Communication about Safe Sex I 35 Min

32. REMAS: Real Men are Safe Session 5 Talking about sex II I. Welcome, redo introductions 5 Min II. Practice Talk with Coaching and Feedback25 Min III. Turning Around What They Say25 Min IV. Workshop Summary25 Min V. Workshop Closure 10 Min

33. Safer Sex Skills Building Description Susan Tross, Ph.D. and the CTN0019 protocol team

34. Features of Effective HIV Preventive Interventions For Women Gender specific Comprehensive skills building > 4 sessions

35. Skills Underlying Safer Sex Sense of self-efficacy about trying safer sex (Marin et al., 1998) Problem-solving skills Negotiation and refusal skills – in as much as male condoms are controlled by men Skills for using female condoms Eroticizing safer sex skills Partner abuse risk assessment and safety planning

36. Theory Social Cognitive Learning Theory: Behavior is learned through the social processes of observation, modeling, skill rehearsal, and feedback, especially with one’s peer group Empowerment Theory: Individuals are empowered to action by the processes of: skill mastery; peer support; and ability to impact on one’s world

37. Health Education Overview HIV Information STD Information HIV Testing and Counseling Living With HIV (Including HIV Treatment Information)

38. Safer Sex Skill Building Overview HIV/STD education, testing & counseling HIV/STD risk assessment HIV/STD safer sex obstacle problem- solving Condom use skill-building Negotiation skill-building Assertiveness training Partner risk assessment and safety planning

39. SSSB: Introduction and HIV/STD Education (Session 1) WORTH (Women On The Road To Health) –Introduction –Purpose –Counselor and Participant roles and rules Warm-up: Why I Want to Take Care of Myself HIV Information STD Information HIV Testing and Counseling Living With HIV (Including HIV Treatment Information) Closing: Homework and WORTH Affirmation

40. SSSB: Making it Real: HIV/STDs in Our Lives (Session 2) Check-in HIV in Our Lives HIV Risk Rationalizations Challenging Rationalizations: Story of Jesse & Mathilde Challenging Rationalizations: Our Own Triggers for HIV/STD Risk Behavior: People, Places, Things Identifying Our Supports For Taking Care Of Ourselves Closing: Homework and WORTH Affirmation

41. SSSB: Making It Real, Tuning Up Our HIV/STD Safer Sex Skills (Session 3) Check-in Getting Smart about HIV/STD Risk: Stop Light Behaviors Condom Use Practice and Feedback – Male Condom Use Practice and Feedback – Female Eroticizing safer sex Self-Talk in Tough Risk Situations Problem-Solving the SODAS Way Closing: Homework and WORTH Affirmation

42. SSSB: Making It Real, Making Safer Sex Happen (Session 4) Check-In Identifying Barriers to Safer Sex Safer Sex Negotiation and Refusal: The Basics Safer Sex Negotiation: Demonstration and Discussion Safer Sex Negotiation: Pairing Up Assessing Risk of Partner Abuse and Making Safety Plans Closing: Homework and WORTH Affirmation

43. SSB: Keeping It Going (Session 5) Check-in Where We’ve Been Together: Review Getting Ready: Common Slip Situations (Especially Involving Drugs & Alcohol) Slip Plans: The SODAS Way Program Evaluation and Feedback Graduation

44. The SODAS Model The letter S –STOP. DEFINE THE PROBLEM AND THE GOAL The letter O –OPTIONS AND OUTCOMES The letter D –DECIDE The letter A –ACTION The letter S –SELF - PRAISE

45. Partner Abuse and Safer Sex Knowing What Abuse Is Identifying Your Risk For Abuse Making A Safety Plan –Safety Plan Worksheet

46. Similarities & Differences between REMAS & Safer Sexual Skills Building Prepared originally by Carol Davidson, M.S.W. Evergreen Treatment Services Seattle, WA

47. Similarities Basic information about HIV & STDs Condom demonstration & practice Identifying triggers for unsafe sex Eroticizing safe sex Communication skills training related to sexual situations

48. Differences REMAS Larger focus on the interplay between sex & drugs Focus on recognizing partner needs and the role played by society’s “gender roles” Stress importance of accepting responsibility for one’s own behavior Use of assertive communication skills & “I” statements in safe sex negotiations

49. Differences SSSB Large focus on increasing a sense of self worth and self efficacy Problem solving skills training for risky sexual situations and relapse prevention Identification and enhancement of positive social support systems Communication skills which stress need to include physical risk assessment and personal safety plan Communication skills training which includes both direct & indirect negotiation and refusal skills

50. Findings from Men’s Protocol: Real Men Are Safe

51. 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. Pacific Northwest Node Co-lead Investigator: Susan Tross, Ph.D. Long Island Node Project Managers: Sara Berns, Ph.D./ Mary Hatch-Maillette, Ph.D. Lead Statistician: Suzanne Doyle, Ph.D. Supported by NIDA (1 U10DA13714-01, Dennis Donovan, PI)

52. Participant Data Flowchart

53. Baseline Socio-demographic Characteristics* *No significant differences between REMAS and HIV Ed on any characteristic

54. Model Based Mean Predicted Values for Primary Outcome Variable (ITT) ES=0.098ES=0.167 Number of unprotected sexual events at baseline, 3 & 6 months as a function of time and intervention group (n=422) 0 5 10 15 20 25 30 Baseline3 Month6 Month Assessment Time Point Unprotected Sexual Acts HIV EDREMAS

55. Model Based Mean Predicted Values for Primary Outcome Variable CompletedNot Completed ES=0.213ES=0.337ES-0.017 ES=0.037 Number of unprotected sexual events at baseline, 3 & 6 months as a function of intervention group and completion status (n=417) 0 5 10 15 20 25 30 Baseline3 Month6 MonthBaseline3 Month6 Month Assessment Time Point Unprotected Sexual Acts HIV EDREMAS

56. Change in Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Intervention Condition * * p=.0065 Intervention x Time, t=2.18, p=0.03 0 5 10 15 20 25 30 35 40 45 50 Baseline3 Month6 Month Assessment Time Point Percents HIV EDREMAS

57. Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Partner Risk Partner Risk, t=3.50, p<.001 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 Baseline3 Month6 Month Assessment Time Point Percents RegularCasual

58. Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Treatment Modality Treatment Modality, t=3.36, p=0.001 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 Baseline3 Month6 Month Assessment Time Point Percents Methadone Outpt. Psy-Soc

59. Sexual Satisfaction as a Function of Sex under the Influence, Baseline to 3 Months * 5 6 7 8 9 Baseline3 months Assessment Time Point Sexual Satisfaction SUI Both SUI 3 Mo. Only SUI Base Only SUI Neither

60. Sexual Satisfaction as a Function of Sex under the Influence, Baseline to 6 Months * 5 6 7 8 9 Baseline6 Months Assessment Time Point Sexual Satisfaction SUI Both SUI 6 Mo. Only SUI Base Only SUI Neither

61. Findings from Women’s Protocol From Susan Tross, Ph.D., and the CTN 0019 Protocol Team

62. HIV/STD SAFER SEX SKILLS GROUPS FOR WOMEN IN METHADONE MAINTENANCE OR DRUG-FREE OUTPATIENT TREATMENT PROGRAMS (CTN 0019) Lead Investigator: Susan Tross, Ph.D. Long Island Node Co-lead Investigator: Donald Calsyn, Ph.D. Pacific Northwest Node Project Managers: Aimee Campbell, Ph.D. Lead Statistician:, Ph.D. Supported by NIDA (1 U10DA-01, Edward Nunes, PI)

63. Participant Data Flowchart

64. Baseline Socio-demographic Characteristics* *No significant differences between SSB and HE on any characteristic

65. Observed (Baseline) and Predicted Means (3- and 6-Months) For USO

66. Effect Sizes 3-Month Follow-Up: –SSB and HE both had similar effects (no significant difference) 6-Month Follow-Up: –USO decreased by 28% in the SSB condition, as compared to the HE condition – reflecting an effect size of.42

67. Observed (Baseline) and Predicted Means (3- and 6-Months) For USO - Completers

68. Observed (Baseline) and Predicted Means (3- and 6-Months) For USO - Non-Completers

69. Predictors of Unprotected Sexual Occasions: Hanner, Tross, Campbell, Cohen and Nunes Lower Age (<40) (p<.0001) Monogamy X Perceived HIV Partner Status: Among those perceiving their partners to be HIV negative, monogamous > non-monogamous women (p<.0001) Sex-with-drug occasions (p<.0001) No methadone versus psychosocial treatment differences

70. Number of Drug or Alcohol With Sex Occasions *p<.03 *

71. Analysis of USO: Summary There was a significant difference in effect of SSB treatment over time (p<.0001), as compared to HE – at 6-month follow-up. This was enhanced by treatment completion. Further, as expected, Monogamy status was a significant predictor of USO (p <.0001), such that: Monogamous women exhibited significantly more (33% more) USO than non-monogamous women.

72. Real World Implications ‘When extrapolated to high-risk populations... Modest changes have the potential to improve public health’ Copenhaver et al., 2006

73. Real World Implications ‘ Increase the comprehensiveness of HIV-prevention interventions ’ ‘ Advance female-controlled methods ’ ‘ Change social and cultural norms regarding sexual behavior ’ ‘ Combine substance abuse treatment with HIV prevention intervention ’ Logan, Cole and Leukefeld, 2002

74. Real Men Are Safe Demonstration Flipcharts for “Sex & Drugs” brainstorming exercise

81. Safer Sexual Skills Building Demonstration.

82. Putting SODAS into Action S: What's the problem? What’s the goal? O: What are your options? D: What would you decide? A: What will you do – to act on your decision? S: Once we decide and act, we deserve a pat on the back for taking care of ourselves!

83. Example Using SODAS (S) Latricia just met this guy James at this party. She kind of knew James before. Latricia and James go back to James's house. Latricia is feeling a little uncomfortable, but she is horny, and James is coming on to her, and he is looking real good. She wants to have sex with him, but she will only have safer sex, because she doesn't want to get anything. S: What is Latricia’s problem and goal? –She wants to have sex with him, but she will only have safer sex and she is feeling unsure of herself and uncomfortable with James.

84. Example Using SODAS (O) What are Latricia’s Options? 1)She can negotiate with him to use a condom 2)She can slip the condom on when she gives him “head” 3)She can have an alternative to intercourse that is safer, like giving him a hand job 4)She can refuse to have any sex: directly (saying no) or indirectly (make an excuse) What are the consequences or Outcomes of each Option? 1)She is feeling unsure of herself and she might not be able to hold up her "bottom line" of having safer sex and using a condom (he might be able to talk her out of it). 2)This might work best. She can avoid having to ask him directly. He may find this sexy, and he won't be able to talk her out of it. 3)She can avoid having to ask him directly. He may find this sexy. She may not be as sexually satisfied as she had hoped. 4)This would protect her, but her goal of having sex would not be achieved.

85. Example Using SODAS (D, A, S) What did Latricia’s Decide? 1) She chooses #2 “Slip the condom on when she gives him head.” 2) She also has an alternative to intercourse, giving him a “hand job” if he strongly objects to a condom. Latricia Acts on her decision. Latricia gives herself Self Praise, “You go girl”

86. Special Thanks! 590Men who participated in the CTN 0018 study 515Women who participated in the CTN 0019 study 24Regional Research Training Center Staff and CTP Principal Investigators 16 Site Coordinators 22 Research Assistants 70 Clinicians and Clinical Supervisors 32 Data Managers and Quality Assurance Monitors

87. Questions

88. Clinical Trials Network ∙ Dissemination Library National Drug Abuse Treatment Find it in the http://ctndisseminationlibrary.org CTN Dissemination Library!