Statistical Analyses Team Naihua Duan, Ph. D

The Healthy Living Project: Outcomes from the NIMH Multi-Site Behavioral Intervention Trial with People Living With HIV

Health Related Interventions for Persons Living With HIV NIMH R10: MH57636 NIMH U10: MH57636

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.

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.

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)

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

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

Qualitative Sample (N = 152)

• MSM = 52

• Women = 56

• IDU Men = 44

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

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)

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

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.

Use of Qualitative Findings In Main 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

Recruitment Sample

• N = 3,819

• Recruited from clinics, community venues, and advertisements

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

Assessment Domains

• Sex Behavior

• Alcohol and Drug Use

• Mental Health

• Stress and Coping

• Social Support

• Physical Health; Healthcare Utilization

• Medical and Medication Adherence

• Biomarkers

Trial Recruitment

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

Social Action Theory

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

Facilitators

• Experienced counselors with backgrounds in mental health

• Centralized training with manualized intervention

• Centralized and local ongoing supervision

Module 1 Stress and Coping

• Session 1 – Assessment: Life context

• Session 2 – Stress and Coping I

• Session 3 – Stress and Coping II

Module 1(cont’d) Stress and Coping

• Session 4 – Social Support

• Session 5 – Maintaining Adaptive Support

Module 2 HIV Transmission Risk Behavior

• Session 1 – HIV-Related Knowledge

• Session 2 – Safer Behavior

Module 2 (cont’d) HIV Transmission Risk Behavior

• Session 3 – Communication Skills

• Session 4 – Disclosure Decisions

• Session 5 – Maintaining Safer Sex

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

Study Completion Rates

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

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

Trial Outcome

Trial Outcome, MSM

Trial Outcome, Women

Trial Outcome, MSW

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

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

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

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.

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.

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.

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.

We want to thank our New York clinical collaborators:

• 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!!!