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

Columbia University

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: CHW Sessions; Device: Wise App with medication adherence reminders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04562649

R01NR019758 (U.S. NIH Grant/Contract)

AAAT2430

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Device: Wise App with medication adherence reminders

Behavioral: CHW Sessions

Control

No Intervention group

Description:

Standard of care