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NCT02641158 · ClinicalTrials.gov registry record · NA
Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 422
- Enrollment target
NCT02641158: Completed NA study, sponsored by Columbia University.
NCT02641158 is a NA study that has completed, run by Columbia University. The registered enrollment target is 422 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02641158, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 422 participants
- Enrollment target
Study Summary
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period. Secondary Objectives: Component 1 (Long-term CTN 0049 follow-up): Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions: 1. HIV virological suppression 2. HIV primary care visit attendance 3. All-cause mortality
Primary Outcome
The primary outcome is a count variable: total # of completed steps along the HCV care continuum by 14 months post-randomization (this is the outside window for the 12-month follow-up visit) minus the total number of steps completed within 12 months prior to baseline. Participants' final step on the HCV care continuum will be assessed the last time they are observed in medical records within the 14-month-long follow-up period. Because the entire sample has HIV, we include 2 HIV-related steps: 1
Interventions
- OTHER Control Group
- BEHAVIORAL Care Facilitation Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2015-12 |
| Est. Completion | 2018-05-09 |
| Phase | NA |
What the finished NCT02641158 record still lists
NCT02641158 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Control Group is the first listed.
NCT02641158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02641158 about?
NCT02641158 is a clinical study titled "Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.". Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Primary Hypothesis: The number of steps achieved along the HCV care continuum wi...
What is the current status of trial NCT02641158?
This trial is currently completed. It is a NA study. The enrollment target is 422 participants. The study started on 2015-12. Estimated completion is 2018-05-09.
What interventions are being tested in trial NCT02641158?
The interventions under investigation include: Control Group (OTHER), Care Facilitation Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT02641158?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02641158's enrollment target sits among peer trials
422 238th of 2000 higher than 1,762 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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