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

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05938413
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wise App with medication adherence reminders
  • Behavioral: CHW Sessions
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention or CHAMPS

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

Outcome Measures

Primary Outcome Measures

  1. Change in Viral Load [Screening, Baseline (not required if a screening visit was completed), 3 month follow up]

    Using dried blood spot samples or electronic health records obtained during study visits, viral load levels will be used to asses ART adherence.

Secondary Outcome Measures

  1. Change in ART adherence - CleverCap [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).

  2. Change in Score on the Self-Rating Scale Item (SRSI) [3 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Able to speak, read, and write in English or Spanish;

  2. Aged ≥18 years;

  3. Willing to provide a valid form of identification for verification;

  4. Willing to participate in any assigned arm of the intervention;

  5. Having been diagnosed with HIV ≥6 months ago;

  6. Have an HIV-1 RNA level >50 copies/mL, or report either not being virally suppressed in the past 12 months or being virally unsuppressed in the past 12 months;

  7. Own a smartphone;

  8. Ability and willingness to provide informed consent for study participation and consent for access to medical records; and

  9. Live in the United States

Exclusion Criteria:

  1. Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;

  2. Terminal illness with life expectancy <3 months;

  3. Planning to move out of the country in the next 3months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University School of Nursing New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Principal Investigator: Rebecca Schnall, PhD, MPH, RN, Columbia University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebecca Schnall, RN, MPH, PhD, Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion (in Nursing) and Professor of Population and Family Health, Columbia University
ClinicalTrials.gov Identifier:
NCT05938413
Other Study ID Numbers:
  • AAAU2064
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion (in Nursing) and Professor of Population and Family Health, Columbia University
ART
PLWH
HIV Infections
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

Study Results

No Results Posted as of Jul 10, 2023