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MEN IN SUBSTANCE ABUSE TREATMENT (CTN 0018)

MEN IN SUBSTANCE ABUSE TREATMENT (CTN 0018). HIV/STD SAFER SEX GROUPS FOR. Presentation at the Annual CTN Mid-Atlantic Node Symposium for Community Providers Baltimore, MD March 28, 2008. Lead Investigator : Donald A. Calsyn, Ph.D. , Alcohol & Drug Abuse Inst., University of Washington

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MEN IN SUBSTANCE ABUSE TREATMENT (CTN 0018)

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  1. MEN IN SUBSTANCE ABUSE TREATMENT (CTN 0018) HIV/STD SAFER SEX GROUPS FOR Presentation at the Annual CTN Mid-Atlantic Node Symposium for Community Providers Baltimore, MD March 28, 2008

  2. Lead Investigator:Donald A. Calsyn, Ph.D., Alcohol & Drug Abuse Inst.,University of Washington Co-Investigators: Mary Hatch-Maillette, Ph.D., ADAI - U of WA, Susan Tross, Ph.D., NY Psychiatric Inst. & Columbia Univ. Suzanne R. Doyle, Ph.D., ADAI - U of WA, Paul Crits-Christoph, Ph.D., U of Penn. Yong S. Song, Ph.D., U of CA San Francisco Judy M. Harrer, Ph.D. U of Cincinnati, VAMC Cincinnati, Genise Lalos, MA.,Prestera Center for Mental Health Services Sara Berns, Ph.D., ADAI - U of WA Supported by NIDA (1 U10DA13714-01, Dennis Donovan, PI)

  3. Background HIV Risk Behavior • Engagement is substance abuse treatment is associated with reduction in HIV risk behaviors. • However, many men 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

  4. Purpose • Develop an HIV sexual risk reduction intervention for men to serves as a companion research protocol to the CTN approved protocol being developed for women. • Incorporate into the intervention elements shown to be efficacious previously, and consistent with current theories on HIV risk reduction interventions. • Compare the effectiveness of the developed intervention (“Real Men Are Safe”) to a standard HIV prevention intervention typicallyprovided in substance abuse treatment settings.

  5. Treatment Sites Red=PsychosocialOutpatient Black=Methadone Maintenance . Seattle Norwalk Hartford Staten Is. . Philadelphia (x2) Toledo . Huntington . . . San Francisco High Point . Raleigh . Columbia . Santa Fe Rancho Cucamonga

  6. 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 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.

  7. Study Schema Screening Assessment -eligible Conduct Baseline Assessment → Place in Waiting Cohort    Randomly Assign Cohort to Intervention  Standard HIV Education Gender Specific Intervention (Real Men Are Safe) (one session) (five sessions)  Conduct 2 Wk. Post Intervention Assessment    Conduct Three Month Follow Up Assessment    Conduct Six Month Follow Up Assessment

  8. Primary and Secondary Outcomes Primary Outcome Variable Number of unprotected vaginal & anal sex events in prior 90 days Secondary Outcome Variables Attitude towards condoms Possession of 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

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

  10. 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

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

  12. REMAS: Real Men are SafeSession 1 HIV/AIDS Update: Identifying Risks I. Group Introductions. Goals and Guidelines10 Min II. Getting Started 10 Min III. HIV Risky Behaviors Exercise 15 MinIV. HIV/AIDS Update15 Min V. HIV Risky Behaviors, injection practices10 MinVI. HIV Risky Behaviors, sexual practices10 MinVII. Condom demonstration10 Min VIII. Revisit Risky Behaviors Exercise 10 Min

  13. REMAS: Real Men are SafeSession 2 HIV/AIDS Update: Planning Prevention I. Welcome, redo introductions 5 Min II. Healthy options10 Min III. Barriers to Condom Use20 Min IV. Condom Practice 25 Min V. Identifying Triggers 15 Min VI. Risk Reduction Problem Solving 15 Min

  14. REMAS: Real Men are SafeSession 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

  15. REMAS: Real Men are SafeSession 4 Beyond the pick up line, communicating about sex I.Welcome, redo introductions 5 Min II. Challenging Stereotypes 20 Min III. Unwritten rules 10 Min IV. Responsibility in sexual relationships 20 Min V. Communication about Safe Sex I 35 Min

  16. ASSERTIVE TALK TOOLS T= Tell my partner "I hear you" A= Assert what I want in a positive way L= List my reasons for wanting to be safe K= Know our alternatives and my bottom line

  17. REMAS: Real Men are SafeSession 5 Communicating about sexII 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 25 Min V. Workshop Closure 10 Min

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

  19. Screening, Baseline & Randomization No Contact 100% condom use other Other Withdrew Pregnancy Planned Left Tx No sex Randomized N=590 Eligible N=661 MMSE < 25

  20. Sample Demographics: Randomized HIV-EDREMASm (sd) m (sd) Age39.4 (10.4) 38.7 (10.6) Education12.4 (2.0) 12.0 (1.7) Income (Mo.)511.4 (1241.3) 530.8 (1114.3) Maritaln (%) n (%) Never137 (45.8)142 (48.8) Married 57 (19.1) 55 (18.9) Div/Wid/Sep 105 (35.1) 94 (32.3)

  21. Sample Demographics: Randomized HIV-EDREMAS Ethnicityn (%) n (%) Black91 (30.4)74 (25.4) White 173 (57.9) 169 (58.1) Hispanic 29 ( 9.7) 37 (12.7) Native Am. 2 ( .7) 6 ( 2.1) Asian 3 (1.0) 2 ( .7) Other 1 ( .3) 3 ( 1.0)

  22. Treatment Exposure, Analysis Sample HIV-ED REMAS 64.8% 58.3%

  23. Follow Up Rates

  24. Data Analytic Approach Primary Outcome (dependent) Variable: # of unprotected vaginal and anal intercourse acts Approach: Mixed Effects Zero-inflated Poisson (ZIP) Regression Model Software: SAS NLMIXED procedure Independent variables used in models: Intervention Condition Time Intervention Completion Covariates used in models: Partner risk (high/low)

  25. Sexual Risk Over Time as a Function of Treatment, ITT ITT Model Results of Mixed Effects Zero-inflated Poisson Regression (n=422) Variable Parameter Standard t-value p Estimate Error Intercept2. 790 0.117 23.84 <.0001 Intervention-0.0450.123-0.37 0.7151 Time -0.252 0.012 -2.14 <.0326 Intervention by Time -0.070 0.017 -4.01 0. 0001 Partner Risk-0.298 0.130 - 2.30 0.0222

  26. Model Based Mean Predicted Values for Primary Outcome Variable (ITT) ES=0.098 ES=0.167

  27. Sexual Risk Over Time as a Function of Treatment, Completers Results of Mixed Effects ZIP Regression (n=417) Variable Parameter Standard t-value p Estimate Error Intercept2.866 0.161 17.77 <.0001 Time -0.103 0.020 -5.26 <.0001 Partner Risk-0.326 0.132 -2.48 0.0137 Intervention-0.0010.2010.00 0.9968 Complete -0.090 0.181 -0.49 0.6211 Intervention by Time 0.022 0.028 0.78 0.4357 Intervention by Complete -0.121 0.257 -0.47 0.6379 Time by Complete 0.122 0.025 4.98 0.0001 Intervention by Time by Complete -0.151 0.036 -4.19 0.0001

  28. Model Based Mean Predicted Values for Primary Outcome Variable Completed Not Completed ES-0.017 ES=0.213 ES=0.337 ES=0.037

  29. Conclusions • An intensive gender specific HIV prevention intervention was associated with greater sexual risk reduction among men in substance abuse treatment compared to a standard HIV education intervention. • Among those patients who attended study intervention sessions, an even larger effect was observed. • The effect remained strong at the six month follow up.

  30. Limitations • The primary outcome data was self report, although social desirability was lessened with ACASI methodology. • Counselors received 30 hours of training and ongoing monitoring. Unclear if findings would replicate with less intense training & supervision. • The active ingredient for the effect is unclear.

  31. 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

  32. 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

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

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

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

  36. 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

  37. 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

  38. 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 Paul McLaughlin Michael Bogenschutz Franklin Ingram Patrick McAuliffe Rowena Baca Megan Ghiroli

  39. Quality Assurance and Data Management Tammy Day Catherine Otto Emily DeGarmo Sharon Pickrel Royce Sampson Stephanie Gentilin Donna Hertel Karen Loncto Lin Denton Michael Shopshire Jennifer Borrow Ellen Silber Terri DeSouza Peggy Samoza David Bennett Jeff Annon Jim Robinson

  40. Site Coordinators Esther Ricardo-Bulis Jenifer Skelding Sarah 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 Sheila Clark Kathy Norins Stacy Inman Anita Carter

  41. 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 Brandi Buchas Denise McRae Brianne O’Sullivan Barbara Hobbs Kyra Porter Pamela Phillips

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

  43. 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 Patrick 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 Bryan Jackson

  44. NationalDrugAbuseTreatment Clinical Trials Network ∙ Dissemination Library Find it in the CTN Dissemination Library! http://ctndisseminationlibrary.org

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