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

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Managed Problem Solving (MAPS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAPS+<br> | Behavioral: Managed Problem Solving (MAPS)<br>* 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.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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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 |