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NCT03135886 · ClinicalTrials.gov registry record · NA
Project I Test: Implementing HIV Testing in Opioid Treatment Programs
A NA study of Opioid Use Disorder and Hepatitis C, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 418
- Enrollment target
- 1
- Study location
NCT03135886: Recruiting NA study of Opioid Use Disorder and Hepatitis C, sponsored by Columbia University.
NCT03135886 is a NA study of Opioid Use Disorder and Hepatitis C that is actively recruiting participants, run by Columbia University. The registered enrollment target is 418 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135886, a NA study of Opioid Use Disorder and Hepatitis C, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 418 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Information Control
- OTHER HIV and HCV Testing Practice Coaching Intervention
- OTHER HIV Testing Practice Coaching Intervention
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT03135886 shows while recruiting
NCT03135886 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Information Control is the first listed.
NCT03135886 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03135886 about?
NCT03135886 is a clinical study titled "Project I Test: Implementing HIV Testing in Opioid Treatment Programs". 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 seeki...
What is the current status of trial NCT03135886?
This trial is currently recruiting. It is a NA study. The enrollment target is 418 participants. The study started on 2017-06-12. Estimated completion is 2026-07-31.
What conditions does trial NCT03135886 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Hepatitis C, Substance Use Disorders, HIV/AIDS.
What interventions are being tested in trial NCT03135886?
The interventions under investigation include: Information Control (OTHER), HIV and HCV Testing Practice Coaching Intervention (OTHER), HIV Testing Practice Coaching Intervention (OTHER).
Who is sponsoring clinical trial NCT03135886?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03135886 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03135886's enrollment target sits among peer trials
418 44th of 257 higher than 214 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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