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

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ClinicalTrials.gov Identifier: NCT04562649
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rebecca Schnall, RN, MPH, PhD, Columbia University

Tracking Information
First Submitted Date  ICMJE September 18, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE May 3, 2021
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
Change in Viral Load [ Time Frame: Baseline, 6 month follow up, 12 month follow up ]
Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • Change in 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 it is a count response (number of times taking medication each day).
  • Change in Score on the Self-Rating Scale Item (SRSI) [ Time Frame: 6 month follow up, 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Health Worker And MHealth to ImProve Viral Suppression
Official Title  ICMJE Community Health Worker And MHealth to ImProve Viral Suppression
Brief Summary 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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: Intervention
    Wise App that delivers medication adherence reminders and community health worker sessions
    Interventions:
    • Device: Wise App with medication adherence reminders
    • Behavioral: CHW Sessions
  • No Intervention: Control
    Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Schnall, PhD, MPH, RN 212-342-6886 rb897@cumc.columbia.edu
Contact: Olivia Wood 212-305-8198 orw2104@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04562649
Other Study ID Numbers  ICMJE AAAT2430
R01NR019758 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rebecca Schnall, RN, MPH, PhD, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Rebecca Schnall, PhD, MPH, RN Columbia University
PRS Account Columbia University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP