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

NCT05938413 | Completed Results FDA Device

• 1 other identifier: AAAU2064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

ART; PLWH; HIV Infections; Acquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (1)

• Viral Load

  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.

  3 months

Secondary Outcomes (2)

• Antiretroviral Therapy (ART) Adherence - CleverCap

  Up to 3 months

• Score on the Self-Rating Scale Item (SRSI)

  3 months

Study Arms (2)

Intervention or CHAMPS

EXPERIMENTAL

Wise App that delivers medication adherence reminders and community health worker sessions

Device: Wise App with medication adherence reminders; Behavioral: CHW Sessions

Control

NO INTERVENTION

Standard of care

Interventions

Wise App with medication adherence reminders DEVICE

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

Intervention or CHAMPS

CHW Sessions BEHAVIORAL

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

Intervention or CHAMPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University School of Nursing

New York, New York, 10032, United States

Location

Related Publications (1)

• Shourya S, Liu J, McInerney S, Casimir T, Kenniff J, Kershaw T, Batey D, Schnall R. A Remote Intervention Based on mHealth and Community Health Workers for Antiretroviral Therapy Adherence in People With HIV: Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Apr 2;9:e67997. doi: 10.2196/67997.

  PMID: 40173448 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Rebecca Schnall, PhD, MPH, RN
• Organization: Columbia University

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, MPH, RN

  Columbia University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion (in Nursing) and Professor of Population and Family Health

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 10, 2023
• Study Start: July 20, 2023
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)