Clinical trial NCT04560621: Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Undetectable HIV viral load (<20 copies/ml)
timeFrame: One year
Secondary outcomes:
measure: Adherence to HIV therapy
timeFrame: One year
measure: Retention in care
timeFrame: One year
measure: CD4 Count
timeFrame: One year
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper Early Intervention Program and Infectious Diseases
state: New Jersey
city: Philadelphia
country: United States
facility: The Drexel Partnership Comprehensive Care Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: MacGregor Infectious Diseases Clinic at the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson HIV Ambulatory Care Program
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Philadelphia
country: United States
facility: PHMC Care Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Comprehensive HIV Program
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Immunodeficiency Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mazzoni Center
state: Pennsylvania
Study officials:
References: