Project I Test: Implementing HIV Testing in Opioid Treatment Programs

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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).

Conditions:

🦠 HIV/AIDS 🦠 Hepatitis C 🦠 Substance Use Disorders 🦠 Opioid-use Disorder

🗓️ Study Start (Actual) 12 June 2017

🗓️ Primary Completion (Estimated) 31 July 2025

✅ Study Completion (Estimated) 31 January 2026

👥 Enrollment (Estimated) 51

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 New York, New York, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Eligible sites must:
1. See at least 150 unduplicated patients/year/site
2. 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
3. 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
4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study

Exclusion Criteria:

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 26 April 2017
First Submitted that Met QC Criteria 26 April 2017
First Posted 2 May 2017

Study Record Updates

Last Update Submitted that Met QC Criteria 18 June 2024
Last Update Posted 21 June 2024
Last Verified June 2024