Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Recruiting now · Not applicable

Conditions studied: HIV/AIDS, Hepatitis C, Substance Use Disorders, Opioid-use Disorder

In brief

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).

Key facts

Study ID

NCT03135886

Run by

Columbia University

People needed

418

Starts

2017-06-12

Expected to finish

2026-08-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible sites must:
• See at least 150 unduplicated patients/year/site
• Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and/or HCV tests; b) completed these tests; c) are referred to care/evaluation (and type of referral) if positive; and d) are linked to care/evaluation within 30 days of diagnosis
• Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race/ethnicity (in aggregate) and data on HIV/HCV test reimbursement processes and outcomes
• Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study

You may not qualify if…

• Sites will be excluded if:
• Over 50% of patients served in the prior 6 months were HIV or HCV tested
• They are terminated via PI decision/discretion

Where it is running

• Columbia University Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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