Marya Viorst Gwadz, Ph.D. Center for Drug Use and HIV Research (CDUHR),

1. Racial/ethnic and Gender Disparities in AIDS Clinical Trials: A Multi-method Evaluation of a Behavioral Intervention Marya Viorst Gwadz, Ph.D. Center for Drug Use and HIV Research (CDUHR), Institute for AIDS Research National Development and Research Institutes, Inc. (NDRI) New York, NY 9/25/2008

2. Overview Causes of disparities in ACTs Efficacy of a brief behavioral intervention Barriers to screening, eligibility, enrollment Experiences of ACT screening among PLHAs

3. Collaborators Beth Israel Medical Center (D. Mildvan, MD) Housing Works (K. Cylar, CSW) NDRI (M. Gwadz, Ph.D.)

4. Types of AIDS Clinical Trials Treatments for HIV/AIDS Opportunistic infections Co-occurring conditions (HCV) Cancers associated with AIDS Reconstitute immune systems Observational Varying levels of commitment and risk

5. Background – HIV/AIDS disparities Racial/ethnic minorities are 33% of population Racial/ethnic minorities 70%of AIDS cases > 80% of women with HIV/AIDS are minorities

6. Implications of HIV/AIDS disparities Greater morbidity Greater mortality, early mortality Treatment delays, sub-optimal treatment Disparities are increasing

7. ACT disparities African-American men and women 28.8% (n=2,218) of AACTG participants are African-American (2003)

8. Why are ACT disparities problematic? Individual PLHA Denies access to treatments, knowledge Denies high level of attention and care Denies chance to contribute to community Research Likely limits generalizability of research findings May reduce treatment efficacy Ethics Perpetuates long-standing barriers Likely contributes to HIV/AIDS disparities

9. ACT disparities are complex History, mistreatment , fear, mistrust, misinformation Individual Social Network Organizations & providers (health care, social service) Clinical trials units Clinical trials inclusion/exclusion criteria 9

10. ACT disparities are complex History, mistreatment , fear, mistrust, misinformation Individual Norms, misinformation Social Network Organizations & providers (health care, social service) Clinical trials units Clinical trials inclusion/exclusion criteria 10

11. ACT disparities are complex History, mistreatment , fear, mistrust, misinformation Individual Norms, misinformation Social Network Low #s referrals Organizations & providers (health care, social service) Clinical trials units Clinical trials inclusion/exclusion criteria 11

12. ACT disparities are complex History, mistreatment , fear, mistrust, misinformation Individual Norms, misinformation Social Network Low #s referrals Organizations & providers (health care, social service) Low outreach, intervention Clinical trials units Clinical trials inclusion/exclusion criteria 12

13. ACT disparities are complex History, mistreatment , fear, mistrust, misinformation Individual Norms, misinformation Social Network Low #s referrals Organizations & providers (health care, social service) Low outreach, intervention Clinical trials units Mismatch?? Clinical trials inclusion/exclusion criteria 13

14. The ACT1 Project Exploratory Brief intervention with PLHA Pre-test, post-test design Multi-level qualitative research PLHA Case managers Medical providers Clinical trials staff

15. Steps toward ACT enrollment

16. Why promote screening among POC/women? Base rates of screening are negligible Screening is very low risk/no risk Knowledge Allays concerns and fears Altruistic Builds relationships between PLHA and CTU Information to stakeholders Enrollment 16

17. ACT1 intervention key characteristics Social Action Theory Motivational Interviewing Three contacts Two group sessions Brief individual phone Health Education Contact (10 – 20 minutes) Manualized Lead by clinician and peer

18. KNOWLEDGE ATTITUDES Beliefs, Fears Mistrust MOTIVATION Willingness Readiness SOCIAL CONTEXT Norms Social Support Providers SKILLS Problem Solving Decisional Balance BACKGROUND Age Gender Socioeconomic Status Race/ethnicity Children CONTEXUTAL INFLUENCES Living Situation Health Status Social Support Substance Use INTERVENTION OUTCOME Screening for ACTs BACKGROUND FACTORS CHANGE MECHANISMS ACTION STATE Intervention core elements

19. Primary target of intervention Individual Social Network Organizations& providers (health care, social service) Clinical trials units Clinical trials inclusion/exclusion criteria

20. ACT1 Project recruitment, retention

21. Demographic characteristics

22. Health and substance use

23. Knowledge of ACTs

24. Willingness to participate in ACTs *** p < .001

25. Willingness to participate in ACTs ** p < .01

26. Intervention efficacy

27. Intervention efficacy - enrollment N = 580 % (of total) Context Attended intervention 539 93% Made screening appt 272 47% Attended screening 143 25% Completed screening 95 16% 11% of those who completed screening Eligible 10 2% Enrolled 6 1% 60% of those eligible

28. The “Leaky Pipe” Total sample N = 580 Lost at each step Attended intervention 93%, n=539 41 (7%) did not attend intervention Made screening appt 47%, n=272 267 (46%) attended intervention but no screening appt Attended screening appt 25%, n=143 129 (22%) made appt but did not attend Completed screening 16%, n=95 48 (8%) attended but did not complete screening Eligible 2%, n=10 Enrolled 1%, n=6 28

29. Intervention dose response ** p < .01, *** p < .001

30. Demographic predictors of screening + p < .10, ** p < .01

31. Health predictors of screening + p < .10

32. Attitudinal predictors of screening *p < .05, ** p<.01

33. Social-level predictors of screening

34. Structural-level predictors of screening + p < .10

35. Multivariate Continuation Ratio Model + p < .10, * p < .05, ** p < .01

36. LESSONS LEARNEDIntegration of quantitative and qualitative findings

37. Barriers to participation – PLHA Mistrust is potent PLHA, families, social networks “Don’t want to be a white man’s guinea pig” Willingness to participate is potent Ambivalence contributes to inaction Lack of information, misinformation

38. Barriers to participation – PLHA 2 Lack of outreach by clinical trials sites, others “We didn’t know they wanted us” Substance use Assume will be excluded Fear stigma “We don’t go to the doctor anyway” Primary care provider relationship Hard to separate screening & enrollment Often did not know screening was incomplete

39. Barriers– health care providers High support for and awareness of ACTs Low #s of referrals for screening Providers have concerns and biases Perfect adherence Treatment of substance users Loss of patients Interference with primary care

40. Barriers – social service providers Lack of information, misinformation Similar mixed attitudes as PLHA Distrust Interest, desire to know more about trials Uncomfortable discussing ACTs due to lower medical knowledge Do not commonly refer PLHA to ACTs

41. Outreach to populations insufficient Outreach cannot address barriers Most clinical trials sites differ from clinic settings Some perceived as not as accommodating More formal, more structured Unfamiliar setting or location Barriers – clinical trials sites

42. Barriers – clinical trials (preliminary data) POC and women may be somewhat less likely to: Complete screening Be found eligible for medical reasons

43. Main medical reasons for ineligibility Lack of provider pre-screening Current/past VL, CD4, and ART mismatches E.g., “bad-good” patterns instead of “good-good” E.g., high VL and high CD4 counts, vice versa Treatment naïve more likely to be eligible Understanding medical mismatches can inform future trials Liberalize inclusion criteria? New research questions?

44. PLHA generally had positive experiences “The people there were very nice, comfortable, respectable… Made you feel comfortable, you can trust in them. That's basically what you really want, especially doing the studies that's something like what I'm gonna be doing.” Reactions to ineligibility included Mild to moderate disappointment Relief Optimism for future Appreciated access to ACT system In the context of low eligibility - experiences of screening

45. Planning ACT2 – Address leaky pipe Not all ACT1 intervention components were active or necessary Retain combined group, individual format Enhance theoretical model Understand ACT2 intervention’s mechanisms of action Theory of Triadic Influence Social-cognitive and Motivational Interviewing

46. The ACT2 Project Randomized controlled trial design Peer-driven intervention (PDI) More intensive (6 hrs total plus peer education) Repetition, clarity, reduced complexity Addresses structural barriers (S4) Intervention thru screening & enrollment process Regular feedback to ACT stakeholders to inform future trials

47. Theory of Triadic Influence Model 47

48. Primary targets of intervention Individual Social Network Organizations& providers (health care, social service) Clinical trials units Clinical trials inclusion/exclusion criteria 48

49. ACT1 and ACT2 collaborators Beth Israel Medical Center, Clinical Trials Unit Housing Works, Inc. AIDS Service Center Betances Health Center Institute for AIDS Research and the Center for Drug Use and HIV Research (CDUHR), National Development and Research Institutes, Inc. ACT1: Funded by National Institutes of Health Grant # 1U01 46370 to Donna Mildvan, MD. (Marya Gwadz, Site PI at NDRI) ACT2: Funded by National Institutes of Health Grant (NIAID) #R01 AI070005 to Marya Gwadz, Ph.D. The ACT1 and ACT2 Projects are dedicated to the memory of Keith Cylar, Co-founder and Co-CEO of Housing Works (1958-2004), and former Housing Works PI, Project ACT