HIVNET 015 A Randomized Clinical Trial of a Behavioral Intervention to Prevent Acquisition of HIV

2. HIVNET 015 A Randomized Clinical Trial of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men EXPLORE

3. Why do EXPLORE? • Behavioral risk remains high • Resurgence in STDs among MSM • rectal gonorrhea, syphilis • Evidence that the prevalence of HIV infection among MSM is high • HIV incidence has been increasing from levels observed in the late 1980’s and early 1990’s • To date, no behavioral intervention for MSM tested with an HIV endpoint

4. EXPLORE Trial Design • Two-armed, multi-site, randomized trial • Intensive risk reduction vs semiannual risk reduction counseling • 1:1 randomization • Intervention • 10 counseling modules given within 4-6 months of randomization • Followed by quarterly maintenance sessions • Follow-up assessments • HIV testing and risk assessment every six months • Common closeout date: July 31, 2003 • Average follow-up time: 3.25 years

5. EXPLORE Behavioral Intervention • Individualized to participant’s pattern of risk • Sessions 1-3: Introductory & individual risk • Provide basic risk reduction skills • Explore recent risk episodes: Crossing acceptable risk limits • Alcohol, substance use, environments, self-efficacy, communication skills, norms, partner types

6. EXPLORE Behavioral Intervention • Sessions 4-5: Sexual communication • Serostatus, facilitators/barriers to communication • Session 6: Sex, drinking and drugs • Sessions 7-9: Places, events, feelings, partners as triggers • Session 10: Maintenance Plan • Quarterly Follow-up Visits

7. EXPLORE Timeline Recruitment Jan 99 Feb 00 Feb 01 Feb02 Feb 03 July 03

8. EXPLORE Baseline Data Results

9. Screenings and enrollments 4,862 screening visits - Not eligible at screen 53 - HIV(+) by test 93 - Eligible, not enrolled 421 - Enrolled 4,295 (88.3%)

10. Age distribution by enrollment

11. Race/ethnicity distribution by enrollment

12. Enrollment by site Site N Boston 729 Chicago 624 Denver 726 New York 737 San Francisco 736 Seattle 743 TOTAL 4295

13. Recruitment source Source % Clubs, bars,public venues 23 Ads 15 Mailings 14 Friend 13 Street outreach 11 Clinics, MDs 10 Other studies, CBOs, forums 14

14. Demographics Total NYC Age (years) % % 16-19 2 3 20-25 17 21 26-30 21 26 31-35 21 22 36-40 18 15 >40 21 13 Race/ethnicity White 72 54 Latino 15 28 Black 7 12 Asian/Pacific Islander 3 2 Native American 1 0 Mixed and other 2 4

15. Demographics Total NYC Educational level % % <High school 9 11 Some college 26 24 College 36 40 Post college 28 25 Household annual income ($) <12,000 13 18 12,000-29,999 27 24 30,000-59,999 39 37 >60,000 21 21 Currently a student 1618

16. Sex partners in last six months Total NYC No. of male partners % % 0 1 1 1 7 6 2-5 32 30 6-9 17 19 10+ 42 44 Primary relationship No 51 51 HIV negative primary partner 32 31 HIV unknown primary partner 10 13 HIV positive primary partner 7 4

17. Sex partners in last six months Total NYC % % At least one: Partner of unknown status 78 83 HIV negative partner 65 63 HIV positive partner 28 24

18. Sexual risk behaviors in the last 6 months Behavior % Unprotected oral sex with ejaculation 45 Unprotected receptive anal sex 48 Unprotected insertive anal sex 55

19. Combination of risk behaviors Oral:unprotected oral with ejaculation R: unprotected receptive anal I: unprotected insertive anal

20. Sexual risk behaviors in last 6 monthsby serostatus of partners

21. Sexual risk behaviors in last 6 months by partner serostatus, type and number HIV negative partners HIV unknown status partners HIV positive partners

22. Alcohol and drug use in last six months Heavy alcohol=daily drinking of at least four drinks/day or drinking equal to six drinks/occasion

23. Alcohol/ drug use and sexual risk Oral:unprotected oral with ejaculation R: unprotected receptive anal I: unprotected insertive anal

24. Factors: Self-efficacy, communication skills, safer sex norms, enjoyment of unsafe sex %* Low self-efficacy for safer sex 15 Weak social norms for safe sex 18 Poor communication skills 35 Enjoyment of unprotected receptive anal sex 52 Enjoyment of unprotected insertive anal sex 75 * percent scoring < 50 out of 100 self-efficacy: 9 items; communication: 6 items; social norms: 5 items

25. 100 90 80 70 60 50 40 30 20 10 0 N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y N Y URA with HIV+ partners * URA with HIV unknown UIA with HIV+ partners UIA with HIV unknown status partners * status partners * . Percent of men with low scores by sexual risk behaviors White bars: self-efficacy for safer sex Light grey bars: communication skills Dark grey bars: social norms Black bars: enjoyment of unprotected receptive anal sex

26. Combination of risk-related factors, heavy alcohol use and drug use and association with risky sex 56 more combinations in remaining 38% * OR for unprotected receptive or insertive sex with HIV+/? partner

27. Summary (1) • Successful recruitment of large high-risk MSM cohort • Risk related to partner type and number: • MSM with multiple HIV unknown and positive status partners engaging in just as much unprotected anal sex as those with only one primary partner • MSM with multiple HIV positive partners more likely to report unprotected insertive anal sex than unprotected receptive anal sex --> “calculated risk”? • Half of MSM with HIV negative primary partner having unprotected sex --> “negotiated safety”? • Heavy alcohol use and use of other recreational drugs associated with sexual risk

28. Summary (2) • Considerable heterogeneity in distribution of factors influencing sexual risk • Enjoyment of unprotected sex is most common factor • potential barrier to behavior change motivation • Weak communication skills also prevalent factor

29. Summary (3) • Contemporary cohort of MSM is at high risk of HIV infection. • resurgence of STDs • increase in HIV incidence • changes in risk behaviors • Interventions to consider: • known and perceived partner serostatus • relationship status • alcohol and drug use, including injecting • motivation for behavior change • behavioral skills building • individualized, tailored approach

30. Results: What to expect (1) • Descriptive: Intervention vs. standard • Baseline characteristics/behaviors at baseline • age, race/ethnicity, sexual risk behaviors, drug use • Adherence to counseling • Intervention: completion of initial 10 and quarterly sessions; no. of total sessions • Duration of sessions • No. of interim contacts • QA scores • Retention

31. Results: What to expect (2) • Primary analyses • Compare HIV incidence rates in intervention vs. standard arms • 2nd level analyses • Compare HSV-2 incidence • Compare behavioral outcomes • Unprotected anal sex • Serodiscordant unprotected anal sex • Sex associated with alcohol or drug use

32. Results: What to expect (3) • 3rd level analyses • Effect on HIV incidence and behaviors in subgroups • alcohol use, drug use, depression • 4th level analyses • Compare other behavioral outcomes • no. of male partners, frequency of unprotected anal sex, condom use • Effect on HIV incidence and behaviors in other subgroups

33. National dissemination plan • Timeline • December 2003: • Executive summary prepared, reviewed and approved • DAIDS • January 2004: • Summary documents prepared • Manuscript prepared - embargo until publication • February 2004: • HPTN meeting

34. National dissemination plan • Audiences • Study participants • final newsletter • Study staff • work with site PI • Community • CABs, CBOs, service providers, advisory committees, PPG, political bodies, other researchers, etc. • Media • centralized press release and Q&As

35. Co-chairs: Margaret Chesney Thomas Coates Beryl Koblin Site Principal Investigators Susan Buchbinder/Grant Colfax Connie Celum Frank Judson Beryl Koblin Ken Mayer David McKirnan Explore Study Team (1)

36. Fenway Community Health Center: Felipe Agredano, Rodrigo Barahona, Keith Bell, Christine Borges, Manual Burnias, Mark Cayabayab, Dan Church, Allison Cohn, Yvonne Colon, Janet Dargon,Nancy DeSousa, Judy Erdman, Josh Gagne, Eliza Goodhue, Juan Jimenez, William Johnson, Wilfred Labiosa, Ana Lara, Darren LeBlanc, Vin Longo, Marc Manseau, Marshall Miller, Matthew Mimiaga, Elie Mohns, Arnel Montenegro, David Pantalone, Oscar Patino, Tracey Rogers, Edual Ruiz, Liz Salomon, Julio Silva, Laura van der Leeden, Rodney VanDerwarker, Curt Weber. Howard Brown Community Health Center:Althea Batticks, Jason Bird, Liz Bradshaw, Robert Brown, Tom Buckingham, Toni Buckingham, Kelly Carson, Irene Chubinsky, Scott Clark, Scott Cook, Jeff Eichholz, Erica Gaffold,Sanford Gaylord, Mark Hartfield, David Henry, Brent Hope, Dale Gluth, Shane Gosselink, Jenny Hopwood, Laura Hosto, Jennifer Howard, D. J. Jacques, Heather Jandura, Susan Killelea, ndy Knight, Simone Koehlinger, Melissa Kohnke, Felicity LaBoy, Han Lee, Kandis Martin,Nicole Martin, Michele McGrady, Cheron McNeal, Denise Miles, Gino Moore, Michael Munn, Jose Narvaez, Aisha Nawab, Arlette Oblaza, Kevin O’Keefe, Liz Perez, Elisse Pertiller, Kelly Picketts, Borris Powell, Chris Powers, Bart Ramey, Ingrid Rodriguez, Laurez Rutledge, Porfirio Sanchez, Michael Saven, Chris Schmidt, Mark Schulze, Jim Skinner, David Snyder, Al Sorrese, Justin St. Andre, Gerry Taranzo, Ted Taylor, Sonia Torres, Kristin Vanfossan, Gregory Victorianne, Erik Wetz. Explore Study Team

37. Rest of team….