COMPLETED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-02-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04560621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 18 or older
  2. * a man or woman living with HIV
  3. * not retained in care and/or virally suppressed in year prior to trial initiation
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • HIV/AIDS