Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers
1 other identifier
interventional
210
1 country
10
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 3, 2025
July 1, 2025
3.4 years
September 17, 2020
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Undetectable HIV viral load (<20 copies/ml)
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.
One year
Secondary Outcomes (3)
Adherence to HIV therapy
One year
Retention in care
One year
CD4 Count
One year
Study Arms (2)
MAPS+
EXPERIMENTALStandard of Care
NO INTERVENTIONInterventions
MAPS is an individual-level, problem-solving intervention delivered in person and via telephone calls to HIV clinic patients. The intervention focuses on improving medication adherence through an iterative, five-step process which consists of 1) identifying barriers to adherence, 2) brainstorming to generate potential solutions, 3) decision-making and developing a plan of action, 4) implementing the plan, and 5) evaluating and modifying the plan as necessary. In-person sessions include education related to the treatment regimen and to common medication misperceptions; problem-solving to identify daily routines, cues, cognitive aids and social supports; screening to identify barriers related to depression, substance use, toxicity management and competing demands; and review of adherence data to determine where problems have occurred and to develop solutions.
Eligibility Criteria
You may qualify if:
- age 18 or older
- a man or woman living with HIV
- not retained in care and/or virally suppressed in year prior to trial initiation
You may not qualify if:
- \- incarcerated during the duration of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cooper Early Intervention Program and Infectious Diseases
Camden, New Jersey, 08103, United States
The Drexel Partnership Comprehensive Care Practice
Philadelphia, Pennsylvania, 19102, United States
MacGregor Infectious Diseases Clinic at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Jefferson HIV Ambulatory Care Program
Philadelphia, Pennsylvania, 19107, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
PHMC Care Clinic
Philadelphia, Pennsylvania, 19123, United States
Temple Comprehensive HIV Program
Philadelphia, Pennsylvania, 19140, United States
Einstein Immunodeficiency Center
Philadelphia, Pennsylvania, 19141, United States
Mazzoni Center
Philadelphia, Pennsylvania, 19147, United States
Related Publications (1)
Van Pelt AE, Bilker WB, Nkwihorez H, Ghadimi F, Brady KA, Cidav Z, Schriger SH, Beidas RS, Gross R, Momplaisir F. Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers. BMJ Open. 2023 Oct 21;13(10):e079585. doi: 10.1136/bmjopen-2023-079585.
PMID: 37865411DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 23, 2020
Study Start
February 1, 2022
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
July 3, 2025
Record last verified: 2025-07