Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)

Study Overview
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Brief Summary
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The overall goal of this study is to evaluate the feasibility of a remotely delivered CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Detailed Description
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Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy (ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition. Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PLWH are not fully benefitting from ART due to poor adherence. These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as PLWH. Therefore, the development and evaluation of interventions using a cadre of community health workers (CHW) holds promise for addressing these challenges in the US. This study addresses limitations in current research on CHW interventions to improve viral suppression and ART adherence. The ubiquitous nature of mHealth technologies in daily life creates opportunities for health behavior management tools that were not previously possible and has the potential to address many of the healthcare needs of PLWH. The investigators propose to build on strong preliminary data to strengthen a community health worker (CHW) intervention using an existing mHealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Official Title
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Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)

Conditions
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HIV/AIDS

Intervention / Treatment
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* Device: Wise App with medication adherence reminders
* Behavioral: CHW Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to speak, read, and write in English or Spanish; Aged ≥18 years; Willing to provide a valid form of identification for verification; Willing to participate in any assigned arm of the intervention; Having been diagnosed with HIV ≥6 months ago; Have an HIV-1 RNA level >50 copies/mL, or report either not being virally suppressed in the past 12 months or being virally unsuppressed in the past 12 months; Own a smartphone; Ability and willingness to provide informed consent for study participation and consent for access to medical records; and Live in the United States Exclusion Criteria: Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; Terminal illness with life expectancy <3 months; Planning to move out of the country in the next 3months.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention or CHAMPS<br>Wise App that delivers medication adherence reminders and community health worker sessions | Device: Wise App with medication adherence reminders<br>* The Intervention group will receive the Wise App that delivers medication adherence reminders.<br>Behavioral: CHW Sessions<br>* The Intervention group will complete sessions with a community health worker (CHW).<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Viral Load | Using dried blood spot samples or electronic health records obtained during study visits, viral load levels will be used to asses ART adherence. | Screening, Baseline (not required if a screening visit was completed), 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ART adherence - CleverCap | The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 3 months), and it is a count response (number of times taking medication each day). | Up to 3 months | 
| Change in Score on the Self-Rating Scale Item (SRSI) | The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent). | 3 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, PLWH, HIV Infections, Acquired Immunodeficiency Syndrome