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Completed

NCT Number: NCT05938413

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

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.

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Key information

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 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.

Who can participate

Healthy volunteers accepted: No

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

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 >200 copies/mL as verified by provision of medical records, or have a detectable load of >500 copies/mL, as measured by dried blood spot (DBS) sample kits, 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.

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. Viral Load

    Time frame: 3 months

    Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (>= 200 copies/mL in EHR; >= 500 copies/mL in DBS) and not detectable viral load (<200 copies/mL in EHR, <500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline.

Secondary outcomes

  1. Antiretroviral Therapy (ART) Adherence - CleverCap

    Time frame: Up to 3 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 3 months), and it is a count response (number of times taking medication each day). The percentage of their prescribed doses taken will be reported.

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

    Time frame: 3 months

    The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-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

Registry information

Acronym: CHAMPS Pilot

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
Mar 7, 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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