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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Device: Wise App with medication adherence reminders Behavioral: CHW Sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Community Health Worker And MHealth to ImProve Viral Suppression
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
Wise App that delivers medication adherence reminders and community health worker sessions
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).

No Intervention: Control
Standard of care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562649


Contacts
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Contact: Rebecca Schnall, PhD, MPH, RN 212-342-6886 rb897@cumc.columbia.edu
Contact: Olivia Wood 212-305-8198 orw2104@cumc.columbia.edu

Locations
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United States, Alabama
Birmingham AIDS Outreach Recruiting
Birmingham, Alabama, United States, 35233
Contact: Emma Kay, PhD, MSW    205-322-4197    emma@mcwc-bao.org   
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: David Batey, PhD, MSW    205-934-5266    dsbatey@uab.edu   
United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Rebecca Schnall, PhD, MPH, RN    212-342-6886    rb897@cumc.columbia.edu   
Contact: Olivia Wood    212-305-8198    orw2104@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Rebecca Schnall, PhD, MPH, RN Columbia University
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Responsible Party: Rebecca Schnall, RN, MPH, PhD, Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion, Columbia University
ClinicalTrials.gov Identifier: NCT04562649    
Other Study ID Numbers: AAAT2430
R01NR019758 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Rebecca Schnall, RN, MPH, PhD, Columbia University:
ART
PLWH
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases