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NCT01612169 · ClinicalTrials.gov registry record · NA
Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 801
- Enrollment target
NCT01612169 is a NA study that has completed, run by Columbia University. The registered enrollment target is 801 participants.
The verdict
NCT01612169, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 801 participants
- Enrollment target
Study Summary
Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU). Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of \<= 200 copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will differ from each other at the 12 month follow-up. Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of \<= 200 copies/mL) in the PN+CM group will be greater than that in the TAU group. Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than that in the PN group. Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that in the TAU group. Secondary Objectives: 1. To evaluate the effect of the experimental interventions on: HIV virological suppression and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary care and visit attendance; and rate of hospitalizations. 2. To evaluate the effect of the experimental interventions on: drug use frequency and severity; and drug use treatment engagement and session attendance. 3. To assess selected mechanisms of action of the intervention (.i.e. mediators of intervention effect). 4. To assess potential characteristics associated with differential treatment effectiveness (i.e. moderators of intervention effect). 5. To evaluate the incremental cost and cost-effectiveness of the interventions.
Interventions
- BEHAVIORAL Patient Navigation (PN) Group
- BEHAVIORAL Patient Navigator Plus Contingency Management (PN+CM) Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 801 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01612169
The ClinicalTrials.gov registry entry for NCT01612169 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 801 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Patient Navigation (PN) Group is the first listed.
NCT01612169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01612169 about?
NCT01612169 is a clinical study titled "Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users". Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Cont...
What is the current status of trial NCT01612169?
This trial is currently completed. It is a NA study. The enrollment target is 801 participants. The study started on 2012-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01612169?
The interventions under investigation include: Patient Navigation (PN) Group (BEHAVIORAL), Patient Navigator Plus Contingency Management (PN+CM) Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT01612169?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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