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NCT04560621 · ClinicalTrials.gov registry record · NA
Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 210
- Enrollment target
NCT04560621: Completed NA study, sponsored by University of Pennsylvania.
NCT04560621 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 210 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04560621, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
Study Summary
The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategi
Primary Outcome
It is defined as having a viral load \<20 copies/mL using the last available viral load at the end of one year (+/-60 days ) since trial initiation. VLs will be abstracted from the electronic medical record along with the date of lab collection.
Interventions
- BEHAVIORAL Managed Problem Solving (MAPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
What the finished NCT04560621 record still lists
NCT04560621 is an interventional study that assigns participants to a tested intervention. The registered 210 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Managed Problem Solving (MAPS) is the first listed.
NCT04560621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04560621 about?
NCT04560621 is a clinical study titled "Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers". The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trustin...
What is the current status of trial NCT04560621?
This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2022-02-01. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04560621?
The interventions under investigation include: Managed Problem Solving (MAPS) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04560621?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04560621's enrollment target sits among peer trials
210 490th of 2000 higher than 1,505 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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