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

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560621
• Other study ID #: 843553
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: University of Pennsylvania
• Contact: Florence Momplaisir
• Phone: 2157468555
• Email: florence.momplaisir[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
United States	Cooper Early Intervention Program and Infectious Diseases	Camden	New Jersey
United States	Einstein Immunodeficiency Center	Philadelphia	Pennsylvania
United States	Jefferson HIV Ambulatory Care Program	Philadelphia	Pennsylvania
United States	MacGregor Infectious Diseases Clinic at the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mazzoni Center	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	PHMC Care Clinic	Philadelphia	Pennsylvania
United States	Temple Comprehensive HIV Program	Philadelphia	Pennsylvania
United States	The Drexel Partnership Comprehensive Care Practice	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	CD4 Count	It is defined as the measure of CD4 cells using the last available measure since trial initiation.	One year