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Completed

NCT Number: NCT04562649

Community Health Worker And MHealth to ImProve Viral Suppression

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham AIDS Outreach, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wise App with medication adherence reminders

Device

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

CHW Sessions

Behavioral

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

Primary outcomes

  1. Number of Virally Suppressed Participants

    Time frame: 6 month follow up, 12 month follow up

    The number of virally suppressed participants. Viral suppression defined as viral load of <200 copies/mL.

Secondary outcomes

  1. Antiretroviral Therapy (ART) Adherence - CleverCap

    Time frame: Up to 12 months

    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 12 months) and report the number of days used.

  2. Change in Score on the Self-Rating Scale Item (SRSI)

    Time frame: 6 month follow up and 12 month follow up

    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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: CHAMPS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2020
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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