Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Last updated: July 25, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Stimulant Use Disorder

Mood Disorders

Treatment

HIV Testing Practice Coaching Intervention

Information Control

HIV and HCV Testing Practice Coaching Intervention

Clinical Study ID

NCT03135886
AAAQ9986
R01DA043130
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 patientswho a) are offered any HIV and/or HCV tests; b) completed these tests; c) arereferred to care/evaluation (and type of referral) if positive; and d) arelinked to care/evaluation within 30 days of diagnosis

  3. Be capable and willing to provide patient demographics, testing data withindemographic categories of gender and race/ethnicity (in aggregate) and data onHIV/HCV test reimbursement processes and outcomes

  4. Have key staff willing to consent to participate in study surveys, qualitativeinterviews and intervention coaching throughout the study

Exclusion

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

Study Design

Total Participants: 418
Treatment Group(s): 3
Primary Treatment: HIV Testing Practice Coaching Intervention
Phase:
Study Start date:
June 12, 2017
Estimated Completion Date:
July 31, 2026

Study Description

Using the most recent National Survey of Substance Abuse Treatment Services (N-SSATS) data available from the Substance Abuse and Mental Health Services Administration (SAMHSA) as the sampling frame, 51 sites will be randomly selected to participate in the study. Site randomization to condition will occur on a rolling basis. Selected sites will be invited to participate in the study and randomly assigned to one of the three intervention conditions (17 sites per condition) -- information control, HIV PC, and HIV/HCV PC. The control condition will be an HIV testing informational product consisting of the official NIDA/SAMHSA Blending Initiative product, "HIV Rapid Testing in Substance Abuse Treatment Programs," ARTAS intervention information and Pre-Exposure Prophylaxis (PrEP) information that will be provided to OTPs to educate and motivate them about the importance of offering on-site HIV testing and linkage to care. In the active PC conditions, champions and key OTP staff will be provided coaching and support for the implementation of an innovation (i.e., offering HIV testing on-site and linking persons living with HIV to care) and for sustaining resulting improvements in testing.

De-identified aggregate client data on HIV and HCV testing and linkage to care will be provided by the sites for four 6-month-long time intervals: T1 (up to 6 months prior to randomization), T2 (during the intervention/control period, up to 6 months post-randomziation), T3 (7-12 months post-randomization), and T4 (13-18 months post-randomization). Qualitative and quantitative site-level data will also be collected immediately preceding randomization and again during interval T3.

Connect with a study center

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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