Project I Test: Implementing HIV Testing in Opioid Treatment Programs
A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs
2 other identifiers
interventional
418
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedJuly 29, 2025
July 1, 2025
8.6 years
April 26, 2017
July 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.
The period 7-12 months post site-randomization (T3).
Secondary Outcomes (1)
Proportion of OTP patients HIV tested at 12 months post intervention or control
The period 13-18 months post site-randomization.
Other Outcomes (1)
OTPs' incremental cost-effectiveness ratio (ICER)
6 months post randomization (T2).
Study Arms (3)
HIV Testing Practice Coaching Intervention Group
EXPERIMENTALThe 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 and HCV Testing Practice Coaching Intervention Group
EXPERIMENTALThe 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.
Information Control Group
OTHERThe 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.
Interventions
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.
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).
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- Weill Medical College of Cornell Universitycollaborator
- University of Miamicollaborator
- Boston Medical Centercollaborator
- Research Foundation for Mental Hygiene, Inc.collaborator
- San Francisco Department of Public Healthcollaborator
- New York University Abu Dhabicollaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (2)
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.
PMID: 37461594BACKGROUNDFrimpong 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.
PMID: 37749635DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Metsch, PhD
Columbia University
- PRINCIPAL INVESTIGATOR
Daniel Feaster, PhD
University of Miami
- PRINCIPAL INVESTIGATOR
Jemima Frimpong, PhD
New York University Abu Dhabi
- STUDY DIRECTOR
Lauren Gooden, PhD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Sociomedical Sciences
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 2, 2017
Study Start
June 12, 2017
Primary Completion
January 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
The data and associated documentation may become available to other researchers under a data-sharing agreement. All interested researchers must contact the PI and provide a proposal explaining the analysis that will be conducted and specify which IPD is needed to accomplish this.