Toronto I-II 12:45 pm

1. Toronto I-II 12:45 pm • Peer-based interventions in the prevention, engagement and treatment cascade: Opportunities and challenges Jane Simoni Professor of Psychology and clinical psychologist in the development and evaluation of health promotion interventions Discussion Panel: Mike Hamilton,Gareth Henry HaouaInoua, Tara Jewal, Percy Lezard, Sean LeBlanc, Duncan MacLachlan, Moderator: Francisco Ibáñez-Carrasco

2. Opportunities and challenges for peer-based interventions in the HIV prevention, engagement and treatment cascade Jane M. Simoni, Ph.D. University of Washington Ontario HIV Treatment Network: 2013 Research Conference Toronto, Ontario November 18, 2013

3. Research reviews of peer interventions Project PAL: What we tried and what we learned Benefits and challenges to implementing and sustaining peer-based interventions Notes from the field: Recommendations for implementation Overview

4. PEER Support • Global tradition of non-professional, community-based health care workers • Practical knowledge of local needs and preferences • Shared culture facilitates engagement and trust • Diversity of roles reflected in diversity of titles • Community health worker, buddy, promotor, accompagnateur, advocate, lay worker, peer • Policy statements promote use of peers to achieve public health goals, especially among marginalized or disadvantaged populations

5. What Defines a Peer? Essential Elements • Peers share with the target group key personal characteristics, circumstances, or experiences (i.e., “peerness”) • The contributions/benefits of peers’ work derive largely from their status as peers • Peers lack professional training or accreditation/status in the scope of their work • Peers function intentionally according to standard protocols, rather then operating solely as part of a naturally occurring social network Simoni et al., 2011

6. Literature Review: Is peer support beneficial?

7. Are peer interventions for HIV efficacious? A systematic reviewSimoni et al., 2011, AIDS and Behavior • Methods • Searched PubMed and PsychInfo • Search terms: HIV, peer*, intervention(s) • Scanned references and consulted colleagues • Articles published before November 1, 2010 • Written in English • Included articles that: • Peers were the only or a main interventions • Addressed HIV-related health concern as main outcome • Used statistical methods of evaluation • Was a primary report of the results

8. 518 studies were identified 330 excluded during abstract review71 excluded during data extraction process 117 met criteria • 28 were RCTs • 54 quasi-experimental • 35 cross-sectional • Mostly in the US (n=51) but newer studies represent developing world (n=54)

9. Targeted outcomes - n (%) Examples: • unprotected anal intercourse and condom use • perceived risk, perceived importance, beliefs, intention • needle sharing, cleaning needles, methamphetamine use • HIV tests, CD4 counts, tests for STIs, and viral load • electronically monitored adherence, condom sales

10. Format of peer interventions 68 formal meetings or structured groups 40 outreach activities 24 formal one-on-one 15 popular opinion leader Populations – n (%)

11. Efficacy of peer interventions was assessed by summing the number of studies with a supportive result for at least one of the variables in the specified domain (a very liberal estimate). • Overall interventions were efficacious, although the likelihood of a supportive result varied according to outcome domain: Peer interventions appear to be most successful with attitudinal and HIV knowledge outcomes, less so with substance use, risky sex, and biological outcomes. • Outcomes that did not rely on self-report (biomarkers/other) were seldom used and much less likely to offer evidence of success

12. Is study design rigor a moderator of intervention efficacy? • 5 out of 6 domains did not differ in efficacy by study design • The exception was biological outcomes • More rigorous designs were LESS likely to demonstrate support for the peer intervention under study

13. Moderators of outcome domains Study location • Studies in the U.S. were more effective at changing attitudes and cognitions than studies in developing countries Intervention modality • Studies that used outreach were more effective at changing substance use than studies without outreach Population studied • Studies intervening with non-PLWHA were more effective at changing sexual behavior than studies targeting PLWHA • Studies intervening with non-MSM were more effective at changing attitudes/cognitions than studies targeting MSM

14. Conclusions from Simoni et al., 2011 “[F]indings suggest that we can have some confidence in peer interventions, yet more data are needed demonstrating an effect in the most rigorous study designs and with outcomes that are not potentially affected by respondent bias.”

15. Female Sex Workers: A Systematic ReviewKerrigan et al. (2013). AIDS and Behavior. • Review & meta-analysis in low/middle income countries (1990–2010) • 6,664 citations, 10 met inclusion criteria • HIV • n=2 observationalwith protective combined effect (OR: 0.84, 95% CI: 0.71–0.99) • STI infection • n=1 longitudinal showed ê gonorrhoea/chlamydia (OR: 0.51, 95% CI: 0.26–0.99) • Observational studies showed ê gonorrhoea (OR: 0.65, 95% CI: 0.47–0.90), but non-significant on chlamydia and syphilis • Condom use • n=1 RCT showed improvements with clients (ß: 0.3447, p = 0.002) • n=1 longitudinal showed improvements with regular clients (OR: 1.9, 95% CI: 1.1–3.3), but no change with new clients • Observational studies showed improvements with new clients (OR: 3.04, 95 % CI: 1.29–7.17), regular clients (OR: 2.20, 95 % CI: 1.41–3.42), and all clients (OR: 5.87, 95 % CI: 2.88–11.94), but not regular non-paying partners • Conclusion: “Overall, community empowerment-based HIV prevention was associated with significant improvements across HIV outcomes and settings.”

16. Peer-led interventions to reduce HIV risk of youth: A reviewMaticka-Tyndale et al. (2009) Evaluation and program planning • Review and synthesis • n=24 peer-led programs in low/middle income countries • HIV/AIDS risk reduction targeting youth in their communities

17. Peer-led interventions to reduce HIV risk of youth: A reviewMaticka-Tyndale et al. (2009) Evaluation and program planning • Findings • Majority show positive change in knowledge and condom use • Effects on other sexual behaviors and STIs were equivocal

18. Effectiveness of Peer Education Interventions for HIV Prevention in Developing CountriesMedley et al. (2009) AIDS Education and Prevention • Review and meta-analysis • n=30 peer ed interventions in low/middle income countries • January 1990 and November 2006 • Significant Findings •  HIV knowledge (OR: 2.28; 95% CI: 1.88, 2.75) •  IDU equipment sharing (OR: 0.37; 95% CI: 0.20, 0.67) •  condom use (OR: 1.92; 95% CI: 1.59, 2.33) • Non-significant on STIs (OR: 1.22; 95% CI:0.88, 1.71) • Conclusion • “Meta-analysis indicates that peer education programs in developing countries are moderately effective at improving behavioral outcomes but show no significant impact on biological outcomes. Further research is needed…”

19. Effectiveness of peer interventions for youthTolli (2012). Health Education Research • Systematic review • Peer education interventions for youth in European Union • n=17 publications, involving only 5 studies • January 1999 and May 2010 • Conclusion • A few statistically significant and non-significant changes • “[O]verall, compared to standard practice or no intervention, there is no clear evidence of the effectiveness of peer education concerning HIV prevention, adolescent pregnancy prevention and sexual health promotion for young people in the member countries of the European Union. Further research is needed…”

20. Project PALPromoting Adherence for Life

21. Project PAL Promoting Adherence for Life • $1.8 million 5-year NIMH-funded R01 • Full randomized clinical trial based on pilot in the Bronx (Project HAART) • 2 X 2 factorial design, with randomization to: • Buddy • Pager • Buddy & Pager • Standard of Care

22. Recruitment and Eligibility • Recruitment (2003-06) • Madison HIV Primary Care ClinicHarborview Medical Center, Seattle • Nurse specialist • Provider referrals • Eligibility • At least 18 y.o. • Starting or switching antiretroviral medications • English-speaking • No significant cognitive impairment or active psychosis

23. Nurse Recruiting

24. Computer-Assisted Self-Interviews • Patients completed CASI interviews at the clinic

25. Interviewing & Reimbursement Schedule • CASI interviews: $60 at baseline, $20 at 2 weeks, $35 at 3, 6, and 9 months • Telephone interviews at 2 and 4 months ($0) • $35 bonus for returning the EDM cap and completing all 5 interviews • $15 for each buddy mtg • Patients could earn up to $240

26. Conceptual Framework Self - Efficacy Affirmational Satisfaction with Social Adherence Emotional Depression Support Received Regimen Knowledge In formational

27. Main Measures • Perceived social support (both general and adherence-specific) • Self-efficacy to adhere • Depression (CES-D) • Knowledge of HAART • 7-day self-report of missed doses (100% vs less) • Electronic drug monitoring (MEMS) • HIV-1 RNA VL and CD4 Count

28. Bi-monthly Buddy Meetings Discuss adherence Problem-solve around life issues related to adherence Adopt a harm reduction approach to substance use Weekly Phone calls More in-depth individualized support Chance to broach more sensitive issues Better suited for participants with confidentiality concerns 3-Month Buddy InterventionComponents

29. Who were our buddies? Other HIV+ patients from the clinic who were… • Adherent to a HAART regimen • Willing to participate in initial training and ongoing supervision • Socially skilled • Able to commit for 6 months • Referred by staff or self

30. Buddy Training • Content of training • Setting boundaries • Barriers to accepting help • Strategies for adhering • Referring for medical issues • Assessing and referring for psychological distress • Assessing and providing social support • Ongoing bi-monthly group supervision

31. Pager Intervention • 3-month intervention period • Patients in the pager arm received daily individualized text pages reminding them which med & how many to take (i.e., “informational support”) Messages customized to protect patients’ confidentiality Educational and entertainment message also Based on prior data showing the efficacy of alarms in adherence and high prevalence of “forgetting” doses

32. Standard of Care: HAART Protocol • CLINICIAN • Talk about starting medications • COUNSELOR • Talk about the meds & why it is important to take them regularly, possible side effects, drugs interactions • NUTRITIONIST • Talk about the meds and their food requirements and how to use food to help control any of the side effects. • SOCIAL WORKER • Talk about things that could impact how you take your meds, including housing, finances, etc. • CLINICIAN • Again, talk about your readiness to start meds and answer any remaining questions. If you are ready, prescriptions will be written. • PHARMACIST • Answer any questions about your medications and confirm your knowledge and acceptance. Pick up 2-week supply of meds.

33. 223 enrolled SOC (n= 56) Buddy only (n= 58) Pager only (n= 56) Buddy & Pager (n= 53) 2 week (n= 52) 2 week (n=56) 2 week (n= 54) 2 week (n= 51) 2 month phone (n= 51) 2 month phone (n= 48) 2 month (n= 47) 2 month (n= 44) 3 month (n= 51) 3 month (n= 49) 3 month (n= 54) 3 month (n= 51) 4 month phone (n= 49) 4 month phone (n= 44) 4 month phone (n= 46) 4 month phone (n= 45) 6 month (n= 48; 2 pending) 6 month (n= 49; 1 pending) 6 month (n= 49; 1 pending) 6 month (n= 48; 0 pending) 9 month (n= 50; 3 pending) 9 month (n= 47; 5 pending) 9 month (n= 52; 3 pending) 9 month (n= 46; 5 pending) Flow of Participants

34. Results

35. Baseline Socio-demographics

36. Overall Adherence How many doses of your HIV medication did you miss in the last 7 days?

37. Socio-demographic Correlatesof Adherence At 3 months, employed participants were more likely to report 100% adherence than unemployed participants (85.4% vs. 70.6%), χ2(1) = 3.70, p = .05 At 3 months, African Americans were less likely than other participants to report 100% adherence (53.2% vs. 71.6%), χ2(1) = 6.39, p = .01 (Adherence not correlated with gender, income, education, relationship status.)

38. Does Intervention Improve Adherence? • Self-Report • Those receiving buddy support were more likely to have not missed doses in the week prior to post-intervention assessment. Odds ratio = 2.1, p = .02 • No effect for either buddy or pager intervention at 6 or 9-month follow-up

39. Trends in Self-Report Adherence - Buddy - No Buddy - Pager - No Pager Shaded regions = 95% CI

40. Changes in Self-Report Adherence

41. Changes in Self-Report Adherence

42. Intervention Effects – EDM Adherence • Those receiving buddy support had a trend towards taking more doses in the week prior to post-intervention assessment. Estimate = 8.9%, p = .11

43. Trends in EDM Adherence - Buddy - No Buddy - Pager - No Pager Shaded regions = 95% CI

44. Changes in EDM Adherence

45. Changes in EDM Adherence

46. Biological Markers • A priori findings • No significant effect of intervention on • Change in CD4 count • Achieving undetectable viral load

47. Were participants engaged in the interventions? • Pager support • Range: 0 to 96.5% • Mean: 41.1% (SD= 31.1%) • Buddy support • Range: 0 to 6 meetings attended • Mean: 2.8 meetings (SD= 2.2)

48. Biological Markers – Post hoc • Among pager participants, higher pager response rate was associated with: • Greater CD4 count at 3, 6, 9 months. • ↑10% pager response → ↑12-23 CD4 (p’s < .05) • Lower viral load 3 and 9 months • ↑10% pager response → ↓0.1 Log10VL (p’s < .05)

49. Biological Markers – Post hoc • Among buddy participants, greater attendance of peer support meetings was associated with… • A trend towards lower Viral Load at 3 and 6 months. • ↑1 meeting → ↓0.1 – 0.2 log10VL (p’s < .10) • Significantly lower Viral Load at 9 months • ↑1 meeting →↓0.2 log10VL (p < .01)

50. Conclusions Medication adherence starts off high and erodes over time for most patients. An RCT testing buddy & pager adherence promotion strategies demonstrated some success during the first 3 months. Specifically, those receiving buddy support(vs. those who did not) had greater likelihood of reporting100% adherence in the 7 days prior to the 3-month post-intervention interview. Electronic drug monitoring revealed a trend towards improved adherence for those receiving vs. not receiving buddy support.