Community Health Worker And MHealth to ImProve Viral Suppression

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-04-19

Brief Summary

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The overall goal of this study is to evaluate the effects of the 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.

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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 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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Wise App that delivers medication adherence reminders and community health worker sessions

Group Type EXPERIMENTAL

Wise App with medication adherence reminders

Intervention Type DEVICE

The Intervention group will receive the Wise App that delivers medication adherence reminders.

CHW Sessions

Intervention Type BEHAVIORAL

The Intervention group will complete sessions with a community health worker (CHW).

Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wise App with medication adherence reminders

The Intervention group will receive the Wise App that delivers medication adherence reminders.

Intervention Type DEVICE

CHW Sessions

The Intervention group will complete sessions with a community health worker (CHW).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be able to communicate and read in English or Spanish
* Willing to participate in any assigned arm of the intervention
* Diagnosed with HIV ≥6 months ago
* Have an HIV-1 RNA level \>200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
* Have ART adherence \<80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
* Own a smartphone

Exclusion Criteria

* Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
* Terminal illness with life expectancy \<6 months
* Planning to move out of the area in the next 12 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No