Dr Calsyn has no conflicts of interest to

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

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

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

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 ♂/♀, Skills training exercises, A variety of techniques Condom demonstrations, Peer group discussions,

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%)

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.

Treatment Sites Red=Psychosocial Outpatient Black=Methadone Maintenance . Seattle Toledo. Huntington. . San Francisco (18) . . La Puente (19). Santa Fe (18) Rancho Cucamonga (18) Norwalk (18) Hartford Staten Is. Philadelphia (x 2) . High Point. . Raleigh (19) Raleigh Columbia

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 •

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

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

Real Men Are Safe Description Donald Calsyn, Ph. D. and the CTN 0018 protocol team

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

Anything Missing ?

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

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

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

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 Healthy Options 10 Min VI. Condom demonstrations 10 Min VII. Overcoming Barriers to Condom Use 10 Min

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

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

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

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

HIV RISK BEHAVIOR CARDS Abstinence from Massage/ body-to sex or drugs -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 Vaginal sex Anal sex without equipment without a condom bleach Shooting up second/sharing works/needles

REMAS: Real Men are Safe Session 2 HIV/AIDS Update: Planning Prevention I. Welcome, redo introductions II. Healthy options 5 Min 10 Min III. Barriers to Condom Use 20 Min IV. Condom Practice 25 Min V. Identifying Triggers 15 Min VI. Risk Reduction Problem Solving 15 Min

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

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

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 Safety 15 Min III. Experience with combining sex & drugs Enhancements/Impairments 35 Min IV. Enhancing sex without drugs 20 Min V. Coping with sexual impairment without drugs 15 Min

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 Stereotypes 20 Min III. Unwritten rules 10 Min IV. Responsibility in sexual relationships V. Communication about Safe Sex I 20 Min 35 Min

REMAS: Real Men are Safe Session 5 Talking about sex II I. Welcome, redo introductions 5 Min II. Practice Talk with Coaching and Feedback 25 Min III. Turning Around What They Say 25 Min IV. Workshop Summary V. Workshop Closure 25 Min 10 Min

Safer Sex Skills Building Description Susan Tross, Ph. D. and the CTN 0019 protocol team

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

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

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

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

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

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

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

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

SSSB: Making It Real, Making Safer Sex Happen (Session 4) • • Check-In Identifying Barriers to 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

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

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

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

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

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

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

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

Findings from Men’s Protocol: Real Men Are Safe

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 U 10 DA 13714 -01, Dennis Donovan, PI)

Participant Data Flowchart

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

Model Based Mean Predicted Values for Primary Outcome Variable (ITT) Unprotected Sexual Acts Number of unprotected sexual events at baseline, 3 & 6 months as a function of time and intervention group (n=422) 30 25 ES=0. 098 ES=0. 167 20 15 10 5 0 Baseline HIV ED REMAS 3 Month Assessment Time Point 6 Month

Model Based Mean Predicted Values for Primary Outcome Variable Number of unprotected sexual events at baseline, 3 & 6 months as a function of intervention group and completion status (n=417) Unprotected Sexual Acts 30 Completed Not Completed 25 ES=0. 213 20 ES=0. 337 ES-0. 017 ES=0. 037 15 10 5 0 Baseline HIV ED 3 Month REMAS 6 Month Baseline Assessment Time Point 3 Month 6 Month

Change in Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Intervention Condition Percents Intervention x Time, t=2. 18, p=0. 03 50 45 40 35 30 25 20 15 10 5 0 * Baseline HIV ED 3 Month Assessment Time Point REMAS 6 Month *p=. 0065

Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Partner Risk Percents Partner Risk, t=3. 50, p<. 001 70 65 60 55 50 45 40 35 30 25 20 15 10 5 0 Regular Baseline 3 Month Assessment Time Point Casual 6 Month

Percentage of Men Engaging in Sex under the Influence during Last Sexual Event as a Function of Treatment Modality Percents Treatment Modality, t=3. 36, p=0. 001 70 65 60 55 50 45 40 35 30 25 20 15 10 5 0 Methadone Outpt. Psy-Soc Baseline 3 Month Assessment Time Point 6 Month

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

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

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

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 U 10 DA-01, Edward Nunes, PI)

Participant Data Flowchart

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

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

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

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

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

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

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

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.

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

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

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

Safer Sexual Skills Building Demonstration.

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!

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.

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.

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”

Special Thanks! 590 Men who participated in the CTN 0018 study 515 Women who participated in the CTN 0019 study 24 Regional 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

Questions

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