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Completed Not applicable Interventional

Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers

ClinicalTrials.gov ID: NCT04560621

Public ClinicalTrials.gov record NCT04560621. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 9:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers: A Stepped Wedge Hybrid Type II Effectiveness Implementation Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.

Study identification

NCT ID
NCT04560621
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Pennsylvania
Other
Enrollment
210 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2022
Primary completion
Jun 29, 2025
Completion
Jun 29, 2025
Last update posted
Jul 2, 2025

2022 – 2025

United States locations

U.S. sites
10
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Cooper Early Intervention Program and Infectious Diseases Camden New Jersey 08103
The Drexel Partnership Comprehensive Care Practice Philadelphia Pennsylvania 19102
MacGregor Infectious Diseases Clinic at the University of Pennsylvania Philadelphia Pennsylvania 19104
Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania Philadelphia Pennsylvania 19104
Jefferson HIV Ambulatory Care Program Philadelphia Pennsylvania 19107
Philadelphia FIGHT Philadelphia Pennsylvania 19107
PHMC Care Clinic Philadelphia Pennsylvania 19123
Temple Comprehensive HIV Program Philadelphia Pennsylvania 19140
Einstein Immunodeficiency Center Philadelphia Pennsylvania 19141
Mazzoni Center Philadelphia Pennsylvania 19147

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04560621, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 2, 2025 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04560621 live on ClinicalTrials.gov.

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