A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care

Principal Investigator: Michael S. Gordon, D.P.A. (Primary Contact)
Co-Investigator: Joisah D. Rich, M.D. (Brown University Medical School, The Miriam Hospital)
Co-Investigator: Michelle S. McKenzie, M.P.H. (Brown University Medical School, The Miriam Hospital)
Funded By: National Institute on Drug Abuse
Grant #: R01 DA030771
Total Project Period: 9/10 – 6/17

This five-year study has two aims: 1) To determine the willingness of the community corrections population to undergo HIV testing (Seek), 1a) To compare a strategy of rapid HIV testing on site in community corrections to referral to an off site community HIV testing location with a randomized control study (Test). 2) To determine whether people with HIV (both known and newly diagnosed) can be identified in community corrections; 2a) To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections; and 2b) To determine the impact of Project Bridge compared to Treatment as Usual on individuals with HIV recruited through community corrections on : 1) engagement in care; 2) retention in care; and 3) proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable at 6 and 12 months using a pre-post analysis (Treat). A total of 6,000 male and female probationers and parolees in Baltimore City, Maryland (n=3,000) and Providence, Rhode Island (n=3,000) will be randomly assigned (within location and gender) either to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or: 2) Referral by the research staff for rapid HIV testing off site at a community HIV testing site or community health center. The second study is a randomized trial of linkage to HIV care for HIV+ adults recruited through community corrections (probation and parole). All individuals identified by testing positive for HIV or self-reporting themselves as HIV-positive at community corrections will be offered enrollment in a one-year intervention study to examine the ability to improve linkage from no treatment into HIV care. A total of 240 HIV-positive participants (120 in Baltimore and 120 in Providence) will be randomly assigned to one of two conditions: 1) Project Bridge [PB] for 12 months; or 2) Treatment as Usual [TAU] (standard level of care/referral for treatment). Those HIV-positive participants randomized to treatment as usual that fail to engage in treatment (failure to engage in treatment during the three months previous to the 6-month assessment) will be offered a “rescue” opportunity to cross over to the Project Bridge intervention at their 6-month follow-up assessment. Those participants in TAU who refuse the “rescue” option of PB at 6 months will still be eligible for 12-month research follow-up assessments. All participants will be followed up at 3,6, and 12-months.