Results of the Project AWARE Randomized Clinical Trial: A Case for De-Implementation Science in HIV Prevention

1. Results of the Project AWARE randomized clinical trial: A case for de-implementation science in the field of HIV prevention Lisa Metsch, PhDStephen Smith Professor and Chair Department of Sociomedical SciencesMichael M. Davis Lecture University of Chicago November 3, 2015

2. Today’s Talk… ▪ Present the results of the AWARE HIV testing and counseling RCT ▪ Discuss the historical and social context around decisions made re: counseling and testing in the U.S. ▪ Suggest how this issue fits into the emerging field of de-implementation science

4. HIV in the United States in 2015 HIV infected 1.2 million Annual incidence 50,000 Prejeon, 2011 Campsmith M et al, JAIDS April 2010

5. Estimated Incidence of HIV Infection in the U.S.by Transmission Category 2015 Prejean J, Song R, Hernandez A, Ziebell R, Green T, et al. (2011) Estimated HIV Incidence in the United States, 2006–2009. PLoS ONE 6(8): e17502. doi:10.1371/journal.pone.0017502 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0017502

7. First Two Decades of HIV Prevention Interventions

9. Action-oriented precaution Draft Memo from James W. Curran to CDC Director, February 20, 1985 James W. Curran. “Major directions for AIDS prevention in the United States during 1985-1986.” Draft – Feb. 20, 1985. James Curran papers, National Archives, Atlanta, Georgia, Box 12, Folder: “Hopkins AIDS Meeting.”

10. In 1986, CDC advocated for counseling with HIV testing

11. Initial Counseling to talk about limits of Testing and what HIV was

12. Congressional oversight “Do you agree that the vast majority of the studies in this article report that there is no significant short-term or long-term behavior change resulting from counseling and testing?” US House of Representatives. Hearing Before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations. The Politics of AIDS Prevention at the Centers for Disease Control. US Government Printing Office: Washington, D.C., July 2, 1992, p. 176-177.

13. Flat funding, declining yield Centers for Disease Control and Prevention, Advisory Committee on the Prevention of HIV Infection. External Review of CDC's HIV Prevention Strategies. U.S. Department of Health and Human Services, Public Health Service, June 1994, p. 68.

14. 1994 External Review of CDC’s HIV Prevention Strategies Centers for Disease Control and Prevention. External Review of CDC's HIV Prevention Strategies. p. 65.

17. Project RESPECT Results*: HIV Prevention Counseling Effective (*p<0.05) Kamb, M.L., et al., JAMA, 1998

18. Results of Project RESPECT The results of RESPECT demonstrated that client-centered, RRC is effective in reducing STD incidence and risk behaviors and can be conducted in busy public health clinics.

19. Weinhardt, L. S., Carey, M. P., Johnson, B. T., & Bickham, N. L. (1999). Effects of HIV counseling and testing on sexual risk behavior: Meta-analysis of published research, 1985-1997. American Journal of Public Health, 89, 1397-1405

20. “However, Weinhardt et al. inappropriately used their findings to evaluate CDC’s client-centered HIV prevention counseling method.”

21. One on one Risk Reduction CounselingBy 2001-CDC Recommends Counseling Should be Done Everywhere.

23. “The benefit of providing prevention counseling in conjunction with HIV testing is less clear.” Branson BM, Handsfield HH, Lampe MA, et al; CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Recomm Rep 2006; 55(RR-14):1-17. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.

24. CDC National HIV Prevention Conference, 2007

25. “Among persons who test negative for HIV, counseling before and after the test clearly has a beneficial effect on risk behaviors and STD incidences in real-world settings and is relatively inexpensive. In settings where counseling does not meet client-centered counseling standards, it should be improved rather than abandoned, but we may need to recruit community service organizations and non-clinicians in the health care system to help us achieve this aim.”

26. “There is no additional benefit from HIV sexual risk reduction counseling.”

27. Drug and Alcohol Dependence (2012)

28. Top 100 Priority Topics for Comparative Effectiveness Research “Compare the effectiveness of HIV screening strategies based on recent Centers for Disease Control and Prevention recommendations and traditional screening in primary care settings with significant prevention counseling.”

29. In 2011 is there still some benefit from counseling at the time of HIV testing; if so, for whom and at what cost?

30. On-site HIV rapid testing (via fingerstick) with brief participant-tailored prevention counseling vs. On-site HIV rapid testing (via fingerstick) with information only Two Testing Strategies Evaluated in 2-arm RCT

31. Project AWARE ARRA Funded! SITES Columbia, SC Jacksonville, FL Los Angeles, CA Miami, FL San Francisco, CA Pittsburg, PA Portland, OR Seattle, WA Washington, DC • This study is evaluating the effect of counseling on 1 primary outcome: • STI incidence • Secondary outcomes: • Reduction of sexual risk behaviors • Reduction of substance use during sex • Cost and cost-effectiveness of counseling 5012 participants randomized across 9 STD clinics in the U.S. STUDY DESIGN Recruitment and Enrollment STI Testing Baseline Assessment Randomization RESPECT-2 counseling with on-site rapid HIV test Information with on-site rapid HIV test STI testing and ACASI repeated at 6 months

32. Overview of Methods • Recruitment /Screening- Minimal eligibility criteria • STI testing • Behavioral risk assessment • 5012 persons were randomized at 9 STD clinics in the U.S. • Intervention Fidelity and Quality Control • Cost and Cost-Effectiveness Analysis – led by Dr. Bruce Schackman at Cornell University • Supported by infrastructure of the NIDA Clinical Trials Network

33. Biologic Testing • The primary outcome defined as composite STI incidence at 6-month follow-up in which a person was considered positive for STIs if they were positive on any tested STI. • All participants were screened for the following STIs: • Herpes Simplex 2 (HSV-2) • Treponema pallidum (syphilis) • Human Immonodeficiency Virus (HIV) 

34. Biologic Testing (cont.) • In addition to the previous 3 STIs… • All men were screened for urethral GC and CT (via urine testing). • Men who have sex with men were screened for rectal Neisseria gonorrhea (GC) and Chlamydia trachomatis (CT). • All women were screened for vaginal GC and CT (via vaginal swab).

35. Overview of Study Interventions

36. Counseling Intervention • Group 1 intervention is based on CDC’s RESPECT 2* counseling model • RESPECT 2 is an individually tailored but focused (counselor directed) HIV prevention counseling format used in conjunction with rapid HIV testing which aims to: • Increase the individual’s awareness of personal risk for HIV • Assist the individual in creating an HIV risk reduction plan *Metcalf, Douglas, Malotte et al; 2005

37. Counseling Intervention Steps • Provide an introduction • Frame the session • Provide general testing information • Collect and process HIV test finger-stick blood sample • Assess for risk behaviors and factors contributing to risk • Identify participant’s ambivalence around risk behavior • Examine previous risk reduction strategies • Summarize participant’s risks, ambivalence about risk and readiness to change • Assist in developing a specific, participant tailored risk reduction plan • Support participant’s risk reduction plan 37

38. Retention by Site *CHD = County Health Dept.; DPH = Dept .of Public Health

39. Demographics of Persons Randomized (n=5012) • Gender • 65.6% Male • 33.8% Female • 0.5% Transgender • Race/Ethnicity • 31.7% Non-Hispanic White • 45.0% Non-Hispanic Black • 15.3% Hispanic • 8.0% Other • 28% MSM • Age Range • 53.4% 18-29 • 22.4% 30-39 • 14.8% 40-49 • 7.8% 50-59 • 1.4% 60-69 • 0.2% >69

40. Intervention Receipt and Fidelity

41. Primary Outcome Analysis – STI Incidence No significant differences across treatment 1 p = .177 2 p = .442

42. Primary Outcome Analysis: New STIs – Project AWARE *Excludes participants who were positive for this STI at baseline.

43. Subgroup Analysis:Heterosexual and MSM 1 CI is corrected for 3 tests

44. Economic Analysis Methods • Costs were determined by resources used • Time • Materials • Space • Focus on costs that would be incurred in the “real world” • Exclude research-related costs • Report start-up costs separately • Assume Arm 2 (Information Only) does not require centralized start-up training, may require local training • Include overhead 44

45. Median (range) Start-up Costs per Site

46. Mean (standard deviation) Cost per Test Note: pooled standard deviations

47. “Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling.”

48. “In an era of shrinking resources, clinicians and policy makers cannot ignore data that inform efficient clinical practice.” “…results of the AWARE trial support the notion that prevention counseling in conjunction with HIV testing is not effective and should not be included as a routine part of practice.”

49. “Without a huge amount of evidence, public health researchers and practitioners hold strong views on both sides of the counseling debate. We must hold ourselves accountable to rigorous experimental trials to find out how effective risk-reduction counseling really is.”

50. "We will stand with you through every step of this journey until we reach the day possible when all men and women can protect themselves from infection, a day when all people with HIV infection have access to treatment to save their lives. The day when no babies born with HIV and AIDS and achieve what once was hard to imagine, an HIV-free generation. That's the world I want for my daughters, that's what we want for our families.” - President Barack Obama, World AIDS Day, December 2, 2013