Project I Test: Implementing HIV Testing in Opioid Treatment Programs
NCT ID: NCT03135886
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
418 participants
INTERVENTIONAL
2017-06-12
2026-07-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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HIV Testing Practice Coaching Intervention Group
The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients.
HIV Testing Practice Coaching Intervention
The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.
HIV and HCV Testing Practice Coaching Intervention Group
The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients.
HIV and HCV Testing Practice Coaching Intervention
The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).
Information Control Group
The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing.
Information Control
The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.
Interventions
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Information Control
The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.
HIV and HCV Testing Practice Coaching Intervention
The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).
HIV Testing Practice Coaching Intervention
The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.
Eligibility Criteria
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Inclusion Criteria
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
1. Over 50% of patients served in the prior 6 months were HIV or HCV tested
2. They are terminated via PI decision/discretion
18 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Weill Medical College of Cornell University
OTHER
University of Miami
OTHER
Boston Medical Center
OTHER
Research Foundation for Mental Hygiene, Inc.
OTHER
San Francisco Department of Public Health
OTHER_GOV
New York University Abu Dhabi
UNKNOWN
Columbia University
OTHER
Responsible Party
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Lisa Metsch
Professor of Sociomedical Sciences
Principal Investigators
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Lisa Metsch, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Daniel Feaster, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Jemima Frimpong, PhD
Role: PRINCIPAL_INVESTIGATOR
New York University Abu Dhabi
Lauren Gooden, PhD
Role: STUDY_DIRECTOR
Columbia University
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Frimpong JA, Parish C, Feaster DJ, Gooden LK, Matheson T, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Nelson CM, Liguori TK, Toussaint O, Siegel K, Annane D, Metsch LR. 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. Res Sq [Preprint]. 2023 Jun 28:rs.3.rs-3059783. doi: 10.21203/rs.3.rs-3059783/v1.
Frimpong JA, Parish CL, Feaster DJ, Gooden LK, Nelson MC, Matheson T, Siegel K, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Liguori TK, Toussaint O, Annane D, Metsch LR. 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. Trials. 2023 Sep 26;24(1):609. doi: 10.1186/s13063-023-07602-8.
Related Links
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Related Info
Other Identifiers
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AAAQ9986
Identifier Type: -
Identifier Source: org_study_id
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