NCT04562649: CHAMPS

Community Health Worker And MHealth to ImProve Viral Suppression

Completed NA Results posted Last updated 17 February 2025

What this trial tests

NA trial testing Wise App with medication adherence reminders in HIV/AIDS in 300 participants. Completed in 19 April 2024.

Timeline

3 May 2021

Primary endpoint
19 April 2024

19 April 2024

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	300
Start date	3 May 2021
Primary completion	19 April 2024
Estimated completion	19 April 2024
Sites	3 locations across United States

Drugs / interventions tested

• Wise App with medication adherence reminders
• CHW Sessions

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Columbia University

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Virally Suppressed Participants Primary · 6 month follow up, 12 month follow up

The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.

6 months

Group	Value	95% CI
Intervention	97
Control	94

12 months

Group	Value	95% CI
Intervention	79
Control	89

Antiretroviral Therapy (ART) Adherence - CleverCap Secondary · 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 report the number of days used.

Group	Value	95% CI
Intervention	244	± 124

Change in Score on the Self-Rating Scale Item (SRSI) Secondary · 6 month follow up and 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).

Group	Value	95% CI
Intervention	0.04	± 0.13
Control	-0.08	± 0.13

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol.
   Wood OR, Schnall R, Kay ES, Jia H, et al · · 2023 · cited 18× · PMID 37226141 · DOI 10.1186/s12889-023-15616-9
2. Differential Effects of Substance Use on HIV Care and Symptom Outcomes: A Longitudinal Analysis Among People with HIV.
   Hai AH, Schnall R, Batey DS. · · 2025 · cited 1× · PMID 40780810 · DOI 10.1177/10872914251364664
3. Efficacy of CHAMPS for Improving Viral Suppression: A Randomised Clinical Trial.
   Schnall R, Jia H, Brin M, Kay ES, et al · · 2025 · cited 1× · PMID 40634827 · DOI 10.1007/s10461-025-04811-x
4. Social Marketing Perspective on Participant Recruitment in Informatics-Based Intervention Studies.
   Idnay B, Cordoba E, Ramirez SO, Xiao E, et al · · 2024 · cited 1× · PMID 38703337 · DOI 10.1007/s10461-024-04355-6