EXPLORE (HPTN 015) A Randomized Clinical Trial of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men

R Intensive Individual Behavioral Counseling Semi-annual HIV VCT HPTN 015: Project EXPLORE N = 4295 MSM Enrollment 1/99-2/01 > 80% Adherence to 10 one-hour modules delivered over 4-6 months in one-to-one sessions HIV infection endpoint Follow-up to 7/31/3 Koblin et al; Chesney et al, AJPH, July 2003

Design Two-armed, multi-site, prospective randomized controlled Phase II b Trial Intensive risk reduction vs semiannual risk reduction counseling--1:1 randomization HIV testing and risk assessment every six months Study sites: Boston, New York, Chicago, Denver, San Francisco, Seattle

Phase IIb Screening study Three point decision guideline –Discard if reduction in incidence <10% –Efficacious if >35% reduction –Plausible if >10% but <35% reduction

Data collection Sexual risk assessment via ACASI at baseline and q 6 months Also collected data on: –Substance use –Self-efficacy for sex –Communication skills –Safer sex norms –Enjoyment of unprotected sex

Intervention 10 counseling modules Followed by quarterly maintenance sessions Given within 4-6 months of randomization

Motivational Enhancement Clear goal But participants choose risk reduction practices consistent with their values, relationships, supports, and life circumstances Harm reduction Individualized motivators

Intervention Individualized to participant’s pattern of risk Sessions 1-2 are diagnostic Sessions 1-4 provide basic risk reduction skills Explore recent risk episodes with attention to contextual variables Alcohol, substance use, emotions, environments, communication skills, partner types

Sessions 5-10 Focus in detail on each of these contextual variables Attention to individual risk experience and the development of alternative lower risk behaviors Emphasis on harm reduction Session 10--Maintenance Plan

EXPLORE Semiannual visit forms Visit checklist (4-10 pages) Progress note (1 page) SOAP note (2 pages) DATA fax (12 pages) Informed consent update (5 versions, pages) Contact form (2 pages) Lab tracking forms (4 pages) Stipend form (1 page) Approximately 30 pages per semiannual visit = 22,000 pages/yr. per site 30 minutes of staff time completing paperwork per visit

Age

Race/Ethnicity

Reasons for Joining

Counseling Delivery All counseling sessions taped Random 10% rated Goal >80% compliance with manual Median overall is 92% for adherence to initial sessions and 89% for follow-up sessions 68% of participants completed all 10 sessions 74% completed 9 month session 73% completed 21 month session 69% completed 33 month session 67% completed 39 month session

88% (85/90%) at 12 mos 86% (84/89%) at 24 mos 85% (83/87%) at 36 mos 87% (84/91%) at 48 mos Follow-up

Partners in Previous 6 Months No. of Male Partners (n)(%) 0421% 13067% % %  %

Partners in Previous 6 Months at Baseline Visit Primary Relationship(n)(%) None217251% With HIV negative partner137232% With partner of unknown status40910% With HIV-positive partner Non-primary partners 2857% Male partner of unknown HIV status335478% HIV-negative male partner280466% HIV-positive male partner121528%

Sexual Risk Behaviors in Previous 6 Months at Baseline Visit (n)(%) No unprotected sex Unprotected anal sex with HIV+ or unknown % 48% Unprotected insertive anal sex only55013% Unprotected receptive anal sex only3037%

Combinations of risk-related factors and risky sex Self- efficacy Communication skills Social norms Enjoys URA Heavy EtOH Drug use %OR for risky sex No Yes161.7 No YesNoYes162.0 No 11ref No YesNo 81.1 NoYesNoYesNoYes74.2

EXPLORE Operational lessons learned Very large cohorts of high-risk MSM can be successfully recruited and retained in a complex trial with HIV as endpoint…BUT... –Tremendous investment in resources to support staff time and site infrastructure. –Full time retention coordinators needed at all sites. –Careful screening of participants for ability to adhere to trial protocol is critical. –On-site monitoring of adherence to all study procedures and study protocol absolutely necessary.

EXPLORE: What will results mean for the future? If intervention is shown to reduce HIV infection rates, important “proof of concept” that intensive counseling reduces HIV seroincidence among MSM –how will EXPLORE be implemented, or will “EXPLORE lite” be tested? Optimally, intervention will show a reduction in HIV infection rates, with corresponding reductions (20-30%?) in behavior. –If intervention reduces HIV infection rates, but self-reported behavior does not change, what are the implications for future trials using behavior as an endpoint? –If intervention does NOT reduce HIV infection rates, but self-reported behavior is reduced, what are the implications for future trials using behavior as an endpoint?