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

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

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 Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Managed Problem Solving (MAPS)

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence Momplaisir; Phone Number: 2157468555; Email: florence.momplaisir@pennmedicine.upenn.edu

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper Early Intervention Program and Infectious Diseases
      • Contact: Pamela Gorman
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Philadelphia FIGHT
      • Contact: Emily Hiserodt
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • MacGregor Infectious Diseases Clinic at the University of Pennsylvania
      • Contact: Morgan Curran
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania
      • Contact: Alexis Schwartz
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple Comprehensive HIV Program
      • Contact: Ellen Tedaldi
    • Philadelphia, Pennsylvania, United States, 19141
      • Recruiting
      • Einstein Immunodeficiency Center
      • Contact: Aviva Joffe
    • Philadelphia, Pennsylvania, United States, 19147
      • Recruiting
      • Mazzoni Center
      • Contact: Devon Taylor
    • Philadelphia, Pennsylvania, United States, 19123
      • Recruiting
      • PHMC Care Clinic
      • Contact: Oluwafunmike Ojewoye
    • Philadelphia, Pennsylvania, United States, 19102
      • Recruiting
      • The Drexel Partnership Comprehensive Care Practice
      • Contact: Amy Althoff
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Jefferson HIV Ambulatory Care Program
      • Contact: Dagan Coppock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

- incarcerated during the duration of the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: MAPS+	Behavioral: Managed Problem Solving (MAPS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to HIV therapy	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.	One year
Retention in care	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.	One year
CD4 Count	It is defined as the measure of CD4 cells using the last available measure since trial initiation.	One year

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 843553

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No