Clinical Trial

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Recruiting
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Summary
This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV/Hepatitis C virus (HCV) testing and linkage to care among patients seeking/receiving substance use disorder treatment. Aims are: Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV testing. Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care. Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition. Primary Hypothesis: 1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the "initial impact" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary). 2. The HIV/HCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-01-31 -> 2026-08-31 2026-08-08
minor Completion pushed: 2026-07-31 -> 2026-08-31 2026-08-08
Trial Details
NCT Number NCT03135886
Lead Sponsor Columbia University
Collaborators: National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami, Boston Medical Center, Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, New York University Abu Dhabi
Conditions HIV/AIDS, Hepatitis C, Substance Use Disorders, Opioid-use Disorder
Enrollment 418 participants
Start Date 2017-06-12
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-07