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

Not Applicable

Recruiting

• Conditions: HIV/AIDS
• Interventions: Behavioral: Managed Problem Solving (MAPS)

• Registration Number: NCT04560621
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2022-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• 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

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Exclusion Criteria

• incarcerated during the duration of the trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MAPS+	Managed Problem Solving (MAPS)	-

Primary Outcome Measures

Name	Time	Method
Undetectable HIV viral load (<20 copies/ml)	One year	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.

Secondary Outcome Measures

Name	Time	Method
Retention in care	One year	It consists of having ≥1 visit with an HIV provider in each 6-month interval of the follow-up year with ≥60 days between clinic visits.
Adherence to HIV therapy	One year	It is defined as the percentage of prescribed doses taken over 4 months and is calculated by dividing the observed pill-taking events by the number of doses prescribed for the study period.
CD4 Count	One year	It is defined as the measure of CD4 cells using the last available measure since trial initiation.

Trial Locations

Locations (10)

Cooper Early Intervention Program and Infectious Diseases; 🇺🇸 Camden, New Jersey, United States

The Drexel Partnership Comprehensive Care Practice; 🇺🇸 Philadelphia, Pennsylvania, United States

MacGregor Infectious Diseases Clinic at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Jefferson HIV Ambulatory Care Program; 🇺🇸 Philadelphia, Pennsylvania, United States

Philadelphia FIGHT; 🇺🇸 Philadelphia, Pennsylvania, United States

PHMC Care Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States

Mazzoni Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple Comprehensive HIV Program; 🇺🇸 Philadelphia, Pennsylvania, United States

Einstein Immunodeficiency Center; 🇺🇸 Philadelphia, Pennsylvania, United States