NCT05938413: CHAMPS Pilot

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

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing Wise App with medication adherence reminders in HIV/AIDS in 40 participants. Completed in 7 May 2024.

Timeline

20 July 2023

Primary endpoint
7 May 2024

7 May 2024

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	20 July 2023
Primary completion	7 May 2024
Estimated completion	7 May 2024
Sites	1 location 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.

Viral Load Primary · 3 months

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.

Viral Load Not Detectable

Group	Value	95% CI
Control	15
Intervention or CHAMPS	11

Viral Load Detectable

Group	Value	95% CI
Control	2
Intervention or CHAMPS	1

Antiretroviral Therapy (ART) Adherence - CleverCap Secondary · 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). The percentage of their prescribed doses taken will be reported.

Group	Value	95% CI
Intervention or CHAMPS	60.08	± 19.15

Score on the Self-Rating Scale Item (SRSI) Secondary · 3 months

The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-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
Control	5.27	± 1.23
Intervention or CHAMPS	5.25	± 1.17

Sponsor's own description

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.

Publications & conference data

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

1. A Remote Intervention Based on mHealth and Community Health Workers for Antiretroviral Therapy Adherence in People With HIV: Pilot Randomized Controlled Trial.
   Shourya S, Liu J, McInerney S, Casimir T, et al · · 2025 · cited 1× · PMID 40173448 · DOI 10.2196/67997
2. Pro-inflammatory biomarkers associated with depression severity among adults with HIV in New York City.
   Veihman P, Kaw S, Batey DS, Schnall R, et al · · 2025 · PMID 41014912 · DOI 10.1016/j.jpsychires.2025.09.033