1. The Healthy Living Project: Outcomes from the NIMH Multi-Site Behavioral Intervention Trial with People Living With HIV Anke A. Ehrhardt, Ph.D. Susan Tross, Ph.D. Robert H. Remien, Ph.D. Theresa M. Exner, Ph.D. HIV Center for Clinical & Behavioral Studies New York State Psychiatric Institute & Columbia University New York, NY

2. Health Related Interventions for Persons Living With HIV NIMH R10: MH57636 NIMH U10: MH57636 Anke A. Ehrhardt, Ph.D. HIV Center for Clinical & Behavioral Studies New York State Psychiatric Institute & Columbia University New York, NY Thomas Coates, Ph.D. Center for AIDS Prevention Studies, UCSF San Francisco, CA Jeffrey A. Kelly, Ph.D. Medical College of Wisconsin, CAIR Milwaukee, WI Mary Jane Rotheram-Borus, Ph.D. University of California at Los Angeles Los Angeles, CA

3. Statistical Analyses Team Naihua Duan, Ph.D. Cheng-Shien Leu, Ph.D. Lenny Wong, Ph.D. Bruce Levin, Ph. D. Fen Rhodes, Ph.D. Rob Weiss, Ph.D.

4. NY Team Robert H. Remien, Ph.D. (Co-PI)Christine Rollet, LCSW Susan Tross, Ph.D. (Co-PI)Marc Spetalnik, LCSW Theresa M. Exner, Ph.D. Bill Goeren, LCSW Jackie Correale, M.P.H. Lascelles Black, MSW Robert Klitzman, M.D. Stefanie Perkins,Ph.D. Robert Kertzner, Ph.D. Louis Caraballo Elizabeth Hirky, Ph.D.Melissa White, M.S.W. Sheri B. Kirshenbaum, Ph.D.Cathy Zadoretshy, M.A. Lauren Kittel, Ed.D.Leticia Peguero, B.A. Farishta Samimy, B.S.Beatrice Martineau, M.P.H. Madalena Mastrogiacomo, B.S.Doris Otero, B.A. Brooke DiLeone, B.A.Eric Torres, B.A. Cheng-Shien Leu, Ph.D.Harlem Gunness, B.S. Ray Smith Ph.D.Julie Kim, B.S. Erica Eaton, M.S.W.

5. Study Overview NIMH Healthy Living Project HIV-Transmission Risk Behavior Intervention Trial HIV-Transmission Risk Behavior Intervention Trial Four-Cities (NY, LA, Mil, SF) MSM, Women, IDU, Heterosexual Men Qualitative, formative phase (N=152) Recruitment sample (N=3,819) Randomized intervention trial sample (N=936)

6. Presenters Anke A. Ehrhardt, Ph.D.: Introduction Susan Tross, Ph.D.: Qualitative Phase Robert H. Remien, Ph.D.: Intervention Development & Implementation Theresa M. Exner, Ph.D.: Study Outcomes

7. Qualitative Phase: Objectives Elicit emerging issues in HIV prevention, HIV treatment adherence, and coping and quality of life for PLWH (e.g. serosorting, pregnancy decision making, disclosure, meaning of viral load) Tailor intervention to subgroups Account for regional variation

8. Qualitative Sample (N = 152) MSM = 52 Women = 56 IDU Men = 44

9. Qualitative Methods: In-depth Individual Interviews Structured schedule of open-ended questions Structured schedule of open-ended questions and follow-up probes -- Focus on meanings, norms, interpersonal contexts, and daily routines, expected to affect health, risk behavior, adaptation to HIV, and participation in and preferences for behavioral intervention -- Conducted by centrally trained (mock interview trained) interviewers -- Transcribed -- 2-3 hours long -- $25 compensation

10. Qualitative Methods: Coding Eight coders developed initial codebook, of primary codes and sub-codes, by consensus process (4 transcripts, representing each city and each participant subgroup) Paired coders refine codebook, until clear saturation is reached (38 transcripts)

11. Qualitative Methods: Analysis Coding teams coded domain-specific transcript material (e.g. medication adherence) Coding teams organized codes or themes on grids, comparing subgroups and contexts (e.g. past versus current treatment) Coding teams identified quotes illustrative of themes

12. Selected Qualitative Papers (4 of 10) Klitzman, R.L., Kirschenbaum, S.B., Dodge, B. Remien, R.H., Ehrhardt, A.A., Johnson, M.O., Kittel, L.E., Daya, S., Morin, S.F., Kelly, J., Lightfoot, M.J., Rotheram-Borus, M.J. & the NIMH Healthy Living Trial Group. (2004) Intricacies and inter-relationships between HIV disclosure and HAART: A qualitative study. AIDS Care, 16(5), 628-640. Kirschenbaum, S.B., Hirky, A.E., Correale, J., Goldstein, R.B., Johnson, M.O., Rotheram-Borus, M.J., & Ehrhardt, A.A. (2004)’Throwing the Dice’: Pregnancy decision making among HIV+ women in four U.S. cities. Perspectives on Sexual and Reproductive Health, 36(3), 106-113. Hirky, A.E., Kirschenbaum, S.B., Melendez, R.M., Rollet, C., Perkins, S.L., & Smith, R.A. (2003) The female condom: Attitudes and experiences among HIV-positive heterosexual men and women. Women and Health, 37(1), 71- 89. Remien, R.H., Hirky, A.E., Johnson, M.O., Le, G.M, Whittier, D., & Weinhardt, L.S. (2003) Adherence to medication treatment: A qualitative study of facilitators and barriers among a diverse sample of HIV+ men and women four U.S. cities. AIDS and Behavior, 7(1), 61-72.

13. Use of Qualitative Findings In Main Trial Systematic Reporting of Qualitative Findings to Assessment and Intervention Lead Teams, For: Assessment Selection, Development and Tailoring Assessment Selection, Development and Tailoring Intervention Selection, Development and Tailoring Intervention Selection, Development and Tailoring Ongoing Close Collaboration with Assessment and Intervention Lead Teams Presentation of Qualitative Findings at Central Facilitator Training – To Sensitize Them to Subgroups

14. Recruitment Sample N = 3,819 Recruited from clinics, community venues, and advertisements

15. Recruitment Sample (N=3,819) Sub-groups (%) MSM Heterosexual Men Heterosexual Women 51.5 26.3 22.2 Age in years, M42.0 Months living w HIV, M100.6 Currently on HAART (%)83.5 Education (%) Less than high school26.1 College Grad or More13.9 Employment (%) Not currently working69.8 Ethnicity (%) Black/African American48.0 Hispanic/Latino17.8 White, not Hispanic25.9 Multi-racial/Other ethnicity8.3

16. HIV Transmission Risk Behavior N=3,819 More than 75% sexually active 13-28% engaged in sexual HIV transmission risk behavior MSM more likely to have multiple partners, but not to engage in transmission risk behavior

17. Assessment Domains Sex Behavior Alcohol and Drug Use Mental Health Stress and Coping Social Support Physical Health; Healthcare Utilization Medical and Medication Adherence Biomarkers

18. Trial Recruitment Completed Baseline Screening Interview N=3,819 Eligible N=1072 (28.1%) Randomized N=936 (87.3%) Not Eligible N=2,746 (71.9%) Choose Not To Enroll N=136 (12.7%)

19. Intervention Study Design Randomized clinical trial (N=936) Two group design (Immediate vs. Lagged) Two group design (Immediate vs. Lagged) 15 Sessions, 3 modules (Individual ) 3 month breaks between modules Assessments every 5 months to 25 months

20. Module 1 Stress and Coping Module 2 Transmission Risk Behavior Module 3 Medical Care & Adherence 2 mo. 3 mo. 2 mo. BL10 mo5 mo15 mo Intervention and Assessment Timeline 20 mo25 mo

21. Social Action Theory

22. Intervention Sessions 90 minutes Interactive, tailored, one-on-one sessions Content / activities Appraisal & motivation Appraisal & motivation Skills building Skills building Role modeling Role modeling Risk reduction skills (e.g., condom use) Risk reduction skills (e.g., condom use) Negotiation Negotiation Goal setting (includes non HIV-related issues) Goal setting (includes non HIV-related issues) Information: HIV transmission & prevention Information: HIV transmission & prevention

23. Facilitators Experienced counselors with backgrounds in mental health Centralized training with manualized intervention Centralized and local ongoing supervision

24. Module 1 Stress and Coping Session 1 – Assessment: Life context Session 2 – Stress and Coping I Session 3 – Stress and Coping II

25. Module 1 (cont’d) Stress and Coping Session 4 – Social Support Session 5 – Maintaining Adaptive Support C.E.T.

26. Module 2 HIV Transmission Risk Behavior Session 1 – HIV-Related Knowledge Session 2 – Safer Behavior

27. Module 2 (cont’d) HIV Transmission Risk Behavior Session 3 – Communication Skills Session 4 – Disclosure Decisions Session 5 – Maintaining Safer Sex

28. Module 3 Medical Adherence / Healthy Lifestyle Session 1 – Current Health Behaviors Session 2 – Assertive Communication Session 3 – Social Support and Adherence Session 4 – Staying on Track Session 5 – Future Choices

29. Study Completion Rates Control N=469 Intervention N=467 Module 1: 80.3% attended all sessions 5-Month Assess: 83.7% completed Module 2: 74.7% attended all sessions 10-Month Assess: 81.2% completed Module 3: 72.8% attended all sessions 15-Month Assess: 77.5% completed 20-Month Assess: 73.4% completed 25-Month Assess: 73% completed 5-Month Assess: 88.3% completed 10-Month Assess: 83.6% completed 15-Month Assess: 82.7% completed 20-Month Assess: 79.3% completed 25-Month Assess: 80.8% completed

30. Main Outcome Number of unprotected vaginal and/or anal sex acts in the past 3 months with a partner whose HIV status is negative or unknown Number of unprotected vaginal and/or anal sex acts in the past 3 months with a partner whose HIV status is negative or unknown

31. Main Analysis Intention to Treat Treated the participant-specific baseline intercept as a normally distributed random effect Employed random effects Poisson regression model Treatment effects were estimated using a propensity score to adjust for observed baseline differences

32. Trial Outcome

33. Trial Outcome, MSM Change in the number of HIV transmission risk acts across six time points for the intervention and control arms among MSM

34. Trial Outcome, Women Transmission risk acts across six time points for the intervention and control arms among ALL WOMEN

35. Trial Outcome, MSW a The definition of the model predicted mean appears in the Statistical Analysis section; analysis based on 655 observations Mean number of transmission risk acts across partners at baseline and follow-up

36. Study Conclusions (1) This one-on-one counseling intervention was successful in reducing HIV transmission risk behaviors among HIV- positive adults for as long as 20 – 25 months Booster sessions are needed to maintain behavior change over longer periods of time

37. Study Conclusions (2) Elements of successful trial development and implementation included: Utilizing a sound theoretical framework to guide assessment domains and intervention development Utilizing a sound theoretical framework to guide assessment domains and intervention development Conducting qualitative research to inform the intervention and facilitator training Conducting qualitative research to inform the intervention and facilitator training Utilizing collaborations among academic research centers, clinical institutions, and community based organizations Utilizing collaborations among academic research centers, clinical institutions, and community based organizations Providing individual tailoring of intervention content Providing individual tailoring of intervention content

38. Clinical Implications It is feasible to implement a one-on-one counseling sexual risk reduction intervention in clinical and community based settings Sexual risk reduction interventions should be integrated into ongoing clinical care for PLWHA in coordination with strategies to enhance general coping, and improve mental health and healthcare behaviors

39. Selected Papers from Recruitment Sample Remien, R. H., Exner, T. E., Morin, S. F., Ehrhardt, A. A., Johnson, M. O., Correale, J.,Marhefka, S., Kirshenbaum, S. B., Weinhardt, L. S., Rotheram-Borus, R. J., Catz, S., Gore-Felton, C., Chesney, M., Kelly, J., and the NIMH Healthy Living Project Team. (2007). Medication adherence and sexual risk behavior among HIV-infected adults: Implications for transmission of resistant virus. AIDS and Behavior, 11(5), 663-675. Klitzman, R., Exner, T. E., Correale, J., Kirshenbaum, S. B., Remien R. H., Ehrhardt, A. A., Lightfoot, M., Catz, S. L., Weinhardt, L. S., Johnson, M. O., Morin, S. F., Rotheram-Borus, M. J., Kelly, J. A., and Charlebois, E. (2007). It’s not just what you say: Relationships of HIV disclosure and risk reduction among MSM in the post-AART era. AIDS Care, 19(6), 749-756. Remien, R. H, Exner, T. E., Kertzner, R. M., Ehrhardt, A. A., Rotheram- Borus, M. J., Johnson, M. O., Weinhardt, L. S., Kittel, L. E., Goldstein, R. B., Pinto, R. M., Morin, S. F., Chesney, M. A., Lightfoot, M., Gore-Felton, C., Dodge, B., Kelly, J. A., and the NIMH Healthy Living Project Trial Group. (2006). Depressive symptomatology among HIV-positive women in the era of HAART: A stress and coping model. American Journal of Community Psychology, 38(3-4), 275-285.

40. Selected Papers from Recruitment Sample Johnson, M. O., Chesney, M. A, Goldstein, R. B., Remien, R. H., Catz, S., Gore-Felton, C., Charlebois, E. D., Morin, S. F., and the NIMH Healthy Living Project Team. (2006). Positive provider interactions, adherence self-efficacy, and adherence to antiretroviral medications among HIV infected adults: A mediation model. AIDS Patient Care and STDs, 20(4), 258-268. Weinhardt, L. S., Kelly, J. A., Brondino, M. J., Rotheram-Borus, M. J., Kirshenbaum, S., Chesney, M., Remien, R. H., Morin, S., Lightfoot, M., Ehrhardt, A. A., Johnson, M. O., Catz, S. L., Pinkerton, S. D., Benotsch, E. G., Hong, D., Gore-Felton, C., and the NIMH Healthy Living Project Team. (2004). HIV transmission risk behavior among men and women living with HIV in four US cities. Journal of Acquired Immune Deficiency Syndromes, 36(5), 1057-1066.

41. Selected Outcome & Longitudinal Papers The NIMH Healthy Living Project Team. (2007). Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: The Healthy Living Project randomized controlled study. Journal of Acquired Immune Deficiency Syndromes, 44, 213-221. Exner, T.M., Remien, R.H., Ehrhardt, A.A., Leu, C.S. Correale, J., Rotheram-Borus, M.J., Morin, S.F., and the Healthy Living Project Team. (under review). The effects of an individual level intervention on sexual behavior among heterosexually active HIV-infected women: Findings from the Healthy Living Project. Morin, S.F., Shade, S.B., Steward, W.T., Remien, R.H., Rotheram-Borus, M.J., Kelly, J.A., Charlebois, E.D., Johnson, M.O., Chesney, M.A., and the Healthy Living Project Team. (under review). The Effects of an individual level intervention on sexual behavior among HIV-infected men who have sex with men: Findings from the Healthy Living Project.

42. Selected Longitudinal Papers Johnson, M.O., Dilworth, S.E., Neilands, T.B., Chesney, M.A., Rotheram-Borus, M.J., Remien, R.H., Weinhardt, L.S., Ehrhardt, A.A., and Morin, S.F. (Epub, 2008). Predictors of attrition among high risk HIV-infected participants enrolled in a multi-site prevention trial. AIDS & Behavior. Johnson, M.O., Charlebois, E., Morin, S.F., Remien, R.H., Chesney, M.A., and the NIMH Healthy Living Project Team. (2007). Effects of a behavioral intervention on antiretroviral medication adherence among people living with HIV: The Healthy Living Project randomized controlled study. JAIDS, 46(5), 574-580. Johnson, M.O., Charlebois, E., Morin, S.F., Remien, R.H., Chesney, M.A., and the NIMH Healthy Living Project Team. (2007). Effects of a behavioral intervention on antiretroviral medication adherence among people living with HIV: The Healthy Living Project randomized controlled study. JAIDS, 46(5), 574-580.

43. We want to thank our New York clinical collaborators: St. Luke’s Roosevelt Medical Center Rachel Wolfe, Ph.D. Hannah Wolfe, Ph.D. Victoria Sharp, M.D. Beth Israel Medical Center Don Des Jarlais, Ph.D. We would also like to thank all the men & women who participated in this study. Finally, we’d like to thank Jackie Correale for remaining the study’s Project Coordinator through thick and thin!!!