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NCT02363387 · ClinicalTrials.gov registry record · NA
Suppression of HIV 1 RNA in People Living With HIV
A NA study of HIV, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT02363387: Completed NA study of HIV, sponsored by Johns Hopkins University.
NCT02363387 is a NA study of HIV that has completed, run by Johns Hopkins University. The registered enrollment target is 102 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02363387, a NA study of HIV, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from medical clinics that serve adults living with HIV in Baltimore will be randomly assigned to an Incentive or a Usual Care Control group. Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Usual Care Control participants will only receive the standard HIV medical care offered in their clinic. Assessments will be conducted every 3 months throughout the two years of treatment and every 6 months throughout the year following treatment. The primary outcome measure will be the percentage of participants that have undetectable viral loads at the 3-month assessments conducted throughout the 2-year intervention period. Secondary measures will include adherence to HIV care and post-treatment outcomes. The investigators will also assess moderators and mediators of the effects of the incentives on the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and is economically sound, it could be used to improve the health of adults living with HIV, reduce health care costs, and reduce HIV transmission in the community.
Primary Outcome
We will assess the percentage of blood samples that have undetectable viral loads (i.e., \<200 copies/mL) at the eight 3-month assessments conducted throughout the 2-year intervention evaluation period (Y/N at each assessment).
Conditions Studied
Interventions
- BEHAVIORAL Incentives for Viral Suppression
- BEHAVIORAL Standard HIV Medical Care
Study Locations (1)
Maryland
- Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-03 |
| Phase | NA |
What the finished NCT02363387 record still lists
NCT02363387 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Incentives for Viral Suppression is the first listed.
NCT02363387 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02363387 about?
NCT02363387 is a clinical study titled "Suppression of HIV 1 RNA in People Living With HIV". The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from medical clinic...
What is the current status of trial NCT02363387?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2015-11. Estimated completion is 2021-03.
What conditions does trial NCT02363387 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT02363387?
The interventions under investigation include: Incentives for Viral Suppression (BEHAVIORAL), Standard HIV Medical Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT02363387?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02363387 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02363387's enrollment target sits among peer trials
102 148th of 303 higher than 155 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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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