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Anke A. Ehrhardt, Ph.D. Susan Tross, Ph.D. Robert H. Remien, Ph.D. Theresa M. Exner, Ph.D.

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

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Anke A. Ehrhardt, Ph.D. Susan Tross, Ph.D. Robert H. Remien, Ph.D. Theresa M. Exner, Ph.D.

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  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 • 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 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 InMain Trial • Systematic Reporting of Qualitative Findings to Assessment and Intervention Lead Teams, For: • Assessment 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. 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

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

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

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

  19. Intervention and Assessment Timeline Module 3 Medical Care & Adherence Module 1 Stress and Coping Module 2 Transmission Risk Behavior 3 mo. 3 mo. 2 mo. 2 mo. 2 mo. BL 5 mo 10 mo 15 mo 20 mo 25 mo

  20. Social Action Theory

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

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

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

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

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

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

  27. Module 3Medical 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

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

  29. 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

  30. 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

  31. Trial Outcome

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

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

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

  35. 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

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

  37. 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

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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!!!

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