Toronto I-II 8:30 pm Taking an adherence intervention from efficacy to effectiveness

1. Toronto I-II 8:30 pm Taking an adherence intervention from efficacy to effectiveness Jeffrey Parsons Editor of Sexuality Research and Social Policy, Associate Editor of Archives of Sexual Behavior and AIDS and Behavior, past member of the White House Office on National AIDS Policy HIV and Aging Working Group and Chair of the Behavioral and Social Consequences of HIV (BSCH) Study Section of the National Institutes of Health Moderator: Trevor A. Hart Associate Professor in the Department of Psychology at Ryerson University and Adjunct Faculty at the Dalla Lana School of Public Health at the University of Toronto

2. Taking an adherence intervention from efficacy to effectiveness Jeffrey T. Parsons, Ph.D. Distinguished Professor, Department of Psychology Director, Center for HIV/AIDS Educational Studies & Training (CHEST) Hunter College and the Graduate Center of the City University of New York (CUNY) Presented at the OHTN 2013 Research Conference: November 19, 2013

3. My goals • Present on the first (and thus far only) behavioral intervention focused on HIV medication adherence to result in positive immunologic and virologic outcomes. • Discuss evolution of this project into a 2nd RCT and a planned effectiveness trial • Highlight the problems and mistakes we made along the way.

4. Background & Significance • Alcohol use negatively impacts the health of people who are HIV+. • Alcohol has been commonly identified as a factor related to HIV medication adherence. • Even recreational alcohol use has been shown to be associated with non-adherence.

5. Background & Significance • Optimal HAART adherence is less often achieved in patients with alcohol problems due to: • beliefs and misunderstandings about potential negative interactions between alcohol and HAART (interactions which are typically not true!) • exacerbations of side effects by alcohol use • immediate cognitive and behavioral changes from alcohol use (e.g. perceptions of time and maintenance of routines)

6. Study Description • Project PLUS wasaimed at simultaneously improving adherence to HIV meds and reducing drinking among heavy drinking HIV+ men and women in NYC.

7. Project PLUS: Medication Adherence Among HIV-Positive Alcohol Abusers Principal Investigator: Jeffrey T. Parsons, PhD Project Director: ElanaRosof, PhD Assistant Project Director: Joseph C. Punzalan Clinical Supervisor: Brad Thomason, PhD Education Supervisor: Jose Nanin, EdD Data Analyst:Sarit Golub, PhD Recruitment Director:Christian Grov, PhD Graphic Designer: Chris Hietikko, MFA Funded by the National Institute on Alcohol Abuse and Alcoholism R01 AA13556

8. Going backwards in time … Recruitment in 1997-2000

9. Recruitment in 2002-2006

10. Clinic Brochure

11. Methods Eligibility • Confirmed HIV Seropositive Status • On HAART • AUDIT score >= 8 • Heavy drinking >16 drinks/week for men; > 12/week for women • Alcohol problems > Other Drug Problems (MAJOR PROBLEM) • At least 18 years old Random Assignment • Using urn randomization • Matching on gender, AUDIT score and CD4 count • Two arms • intervention • education (attention control) (PARTIAL MAJOR PROBLEM)

12. Assessment • Adherence: • Biological measures: viral load and CD4 count • Self-report measures: Time Line Follow Back (TLFB) calendar for the past 14 days • Alcohol use: • Self-report measures: TLFB for the past 14 days • Number of Standard drinks – summed number of standard drinks across the 14-day period. • Drinks per drinking day - total number of standard drinks in the past 14 days divided by the number of days during that period in which the participant had at least one alcoholic drink • NOTE – No biological measures of alcohol use

13. The Intervention • First two sessions focus exclusively on Motivational Interviewing (MI). • Client picks which behavior to focus on first • Structured computer-generated personalized feedback on both behaviors is provided • Also covers the Information component of the IMB model

14. Motivational Interviewing • A change plan is formulated with the participant: • The changes I want to make are: • The most important reasons why I want to make these changes are: • The steps I plan to take in changing are:

15. The Intervention • Last six sessions use MI and Cognitive Behavioral Skills Building • A menu-approach is used. • Following a functional analysis, specific skills building sessions are chosen based on individual needs of each client and are assessed through a case conceptualization

16. Conducted for each behavior in order to best select skill-building sessions most appropriate for each client Functional Analysis

17. Cognitive Behavioral Skills BuildingProvider chooses 3 modules for each behavior based on client’s skills deficits ADHERENCE • Managing Side Effects • Communication with Health Care Providers • Managing Cravings to Skip Medication • Managing Thoughts to Skip Medication ALCOHOL • Coping with Triggers to Drink • Managing Thoughts to Drink • Refusal Skills • Moderated Drinking EITHER • Increasing Pleasant Activities • Managing Negative Moods • Making Time For Self

18. Control Condition • The control condition consists of eight individual sessions with health educators, using videotapes which provide education around HIV, adherence, and alcohol use, followed by a structured discussion of the information covered. • DANGER, DANGER, DANGER!!!!

19. Non-Hazardous Drinkers (n = 167, 53.87%) Baselined and Randomized Hazardous Drinkers (n = 143, 46.13%) Control Condition (n = 78, 55%) Mean (SD) sessions = 6.95 (2.18) Treatment Condition (n = 65, 45%) Mean (SD) sessions = 6.45 (2.31) Completed 3 Month Follow Up (n = 68, 87%) 3 Month Follow Up not completed (n = 10) 3 Month Follow Up not completed (n = 12) Completed 3 Month Follow Up (n = 53, 84%) Completed 6 Month Follow Up (n = 53, 84%) Completed 6 Month Follow Up (n = 62, 83%) 6 Month Follow Up not completed (n = 16) 6 Month Follow Up not completed (n = 12)

20. Adherence Results • The primary outcome measures were changes in log viral load and CD4 count from baseline to 3-month follow-up. • At baseline, the two groups did not differ significantly in their viral load or CD4 counts. • At 3-months, there was a significant time x condition interaction – such that intervention participants demonstrated significant decreases in viral load, and significant increases in CD4 count, compared to those in the control condition.

23. Drinking Results • Participants in both conditions reported significant decreases in both the number of standard drinks they consumed from baseline to 3 months, F (1, 112) = 62.7, p < .001. • Similarly, all participants reported significant decreases in number of drinks per drinking day from baseline to 3 months, F(1, 112) = 35.1, p < .001. • There were no significant time by condition interaction effects for these variables. • Attention control conditions may change behavior due to assessment effects or just the effects of being in a study. Or it may be that they work! • No good biologic measures for alcohol exist.

24. Results at 6 months • At the 6-month follow-up visit, there were no significant differences between individuals in the intervention and control condition on any outcome variable for adherence or drinking • Average log viral load and CD4 counts remained better among participants in the intervention condition, but the time-by-condition interaction effect did not achieve statistical significance. • Drinking remained lower in both groups, but the interaction effect was not significant. • PROBLEM: NO BOOSTERS

25. Summary • This is the first published behavioral intervention to document efficacy across viral load, CD4 count, and self-reported adherence. • Both the intervention and the educational control sessions were equally efficacious in reducing drinking behaviors. • The reduction in the magnitude of the intervention’s efficacy at 6-month follow-up indicates the importance of intervention booster sessions.

26. Moving beyond PLUS

27. The Meth “Epidemic” • In the first several months of 2004, increasing attention began to focus on the “epidemic” of crystal methamphetamine among gay/bisexual men in NYC and other urban areas.

28. The Meth Epidemic • Gays' Use of Viagra and Methamphetamine Is Linked to Diseases (NY Times 03.11.04) • Crystal Meth Linked to AIDS in New York: “Party” drug increases HIV risk among gays (Reuters 06.07.04) • Rare and Aggressive H.I.V. Reported in New York (NY Times 02.12.05)

29. The Meth Epidemic • Party, Play—And Pay: Multiple partners. Unprotected sex. And crystal meth. It's a deadly cocktail that has stirred new fears about the spread of HIV (Newsweek 02.28.05)

30. Our own research • Through our community-based surveys, we identified a large increase in methamphetamine use among MSM. • Use was significantly higher among HIV+ MSM. • Also identified clear relationships between meth use and sexual risk behaviors.

31. Meth and Adherence • Meth use and dependence were associated with poor adherence and increased viral load. • Meth use has many negative effects on the health of people living with HIV. • Because of the “epidemic” we felt an urgent need to take PLUS and apply it to meth-using MSM

32. ACE: Intervention Targeting Medication Adherence and Methamphetamine Use for HIV+ MSM Principal Investigator: Jeffrey T. Parsons, PhD Co-Investigator:Sarit Golub, PhD Project Director: Julia Tomassilli, PhD Clinical Supervisor: John Pachankis, PhD Education Supervisor: Catherine Holder Neuropsych Coordinator: William Kowalczyk, PhD Senior Data Analyst:Tyrel Starks, PhD Recruitment Director:Kevin Robin Graphic Designer: Chris Hietikko, MFA Funded by the National Institute on Drug Abuse R01-DA023395

33. Study Description • Project ACE isaimed at simultaneously improving HIV medication adherence and reducing meth use among HIV+ MSM in NYC. • Eight-session, manual-driven, individual intervention using a combination of Motivational Interviewing (MI) and Cognitive Behavioral Skills Building (CBST), adapted from Project PLUS. • Driven by the IMB Model of Fisher & Fisher

34. Methods Eligibility • Confirmed HIV+ and taking HAART • >3 missed med days in the last 30 • >3 days of Meth use in the last 90 days • Past sex with men • At least 18 years old Random Assignment • Using urn randomization • Two arms: intervention or education (attention control) WTF?! You didn’t learn the first time???

35. Clinic Brochure

36. Recruitment Cards and Ads

37. Timing sucks • The meth “epidemic” identified in 2004. • First ACE grant submission in late 2005. • Second ACE grant submission in early 2007. • ACE was funded in Sept, 2007 • By 2008, rates of meth use dramatically decreased among MSM in NYC! • In 2008, only 6% of gay men in New York City reported using meth during the previous 12 months.   • That's a 57% drop from the percentage reported in 2004.

40. ACE • We completed recruitment and enrollment, and just finished our last round of follow-ups. • We ended up with a sample size of 210 – after YEARS of recruitment, and trying virtually every approach in the book – active, passive, internet-based, RDS, etc. • Analyses have begun …. More later.

41. Where do we go from here • PLUS and ACE were tested in a very controlled environment (CHEST). • There were numerous inclusion/exclusion criteria that led to a less generalizable sample. • Therapists delivering PLUS were highly trained, and received extensive supervision. • PROBLEM: Would we get the same results in actual HIV clinic settings, using the actual staff?

42. Where do we go from here • So, we submitted an application to NIAAA for a comparative effectiveness trial to test PLUS in 3 clinics in NYC. • Will train existing clinic staff in MI, CBT, and the intervention itself, but will provide limited on-going supervision. • Limited eligibility criteria, few exclusion criteria. • The fact that patients come to clinic regularly for care will permit natural booster sessions. • Funded, and the trial will begin in 2014.

43. Thank you! For further questions or a copy of these slides, please email me: Jeffrey.Parsons@hunter.cuny.edu Or visit: www.chestnyc.org