NCT05938413

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
DEVICE	Wise App with medication adherence reminders	The Intervention group will receive the Wise App that delivers medication adherence reminders.
BEHAVIORAL	CHW Sessions	The Intervention group will complete sessions with a community health worker (CHW).

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2023-07-10
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study