Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID03135886

A Cluster Randomized Trial to Improve HIV Testing and Linkage to Care in Opioid Treatment Programs

Led by Columbia University · Updated on 2025-07-29

418

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two active evidence-based practice coaching (PC) interventions to improve HIV testing and linkage to care in opioid treatment programs (OTPs) among patients receiving substance use disorder treatment. The study aims to compare the effectiveness of these interventions in increasing HIV testing rates, the sustained implementation of testing and timely linkage to care, and the health outcomes and cost-effectiveness of these approaches. This trial involves multiple sites randomly assigned to different intervention groups or a control condition. The study includes three groups: one receives an HIV Testing Practice Coaching intervention focused on implementing on-site HIV testing and linkage to care; another receives an HIV and Hepatitis C Virus (HCV) Testing Practice Coaching intervention that builds on the HIV PC intervention with additional training and support for combined HIV/HCV testing and care; the control group receives informational resources about HIV rapid testing without coaching. The coaching interventions last about 29 weeks (6 months). Sites provide data on HIV and HCV testing and linkage to care across four 6-month time intervals covering periods before, during, and after the intervention. Participants at the site level provide de-identified aggregate data on patient testing and linkage outcomes. Data collection includes quantitative and qualitative assessments at baseline and follow-up intervals up to 18 months post-randomization. The primary outcome focuses on the proportion of patients tested for HIV at 7-12 months post-intervention, controlling for baseline rates. Secondary outcomes include testing rates at 13-18 months. The study monitors the implementation process, health outcomes, healthcare use, and cost-effectiveness throughout the study period.

CONDITIONS

Brief Title

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Sites must serve at least 150 unique patients per year
  • Sites must be able and willing to collect data on HIV and/or HCV testing, referrals, and linkage to care
  • Sites must provide aggregated patient demographic data including gender and race/ethnicity
  • Key staff at sites must agree to participate in study surveys, interviews, and coaching throughout the study
Not Eligible

You will not qualify if you...

  • Sites where over 50% of patients were tested for HIV or HCV in the previous 6 months
  • Sites terminated at the discretion of the principal investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote at site level)

Implementation

Duration - Up to 6 months

Participants engage in implementing HIV testing and linkage to care interventions at their opioid treatment programs, supported by practice coaching or informational resources depending on their assigned condition.

Ongoing site activities during the intervention period

Monitoring

Duration - Up to 18 months post-randomization

Participants' sites provide de-identified aggregate data on HIV and HCV testing and linkage to care at multiple time intervals to assess intervention impact.

Data collection at four 6-month intervals

Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

L

Lauren Gooden, PhD

T

Terri Liguori, M.Ed., Ed.S.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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Published Research Related To This Trial

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

Jemima A Frimpong, Carrigan Parish, Daniel J Feaster...

https://pubmed.ncbi.nlm.nih.gov/37461594

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

Jemima A Frimpong, Carrigan L Parish, Daniel J Feaster...

https://pubmed.ncbi.nlm.nih.gov/37749635