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Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Columbia University · with National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University · NCT03135886

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
418
US sites recruiting
1
Study start
June 12, 2017
Record last updated
August 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

  • 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).
  • 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).

Being studied: Information Control; HIV and HCV Testing Practice Coaching Intervention; HIV Testing Practice Coaching Intervention

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

  • Columbia University Medical Center

    New York, NY 10032

    Site contact: Lauren Gooden, PhD · 786-703-9819 · lkg2129@columbia.edu

Study contacts (from the official record)

  • Lauren Gooden, PhD · 786-703-9819 · lkg2129@columbia.edu
  • Terri Liguori, M.Ed., Ed.S. · 786-510-3666 · tl2547@columbia.edu
Project I Test: Implementing HIV Testing in Opioid Treatment Programs (NCT03135886) | Bored Studies