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CHW Sessions + mHealth for HIV/AIDS (CHAMPS Trial)

N/A
Waitlist Available
Led By Rebecca Schnall, PhD, MPH, RN
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with HIV ≥6 months ago
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow up, 12 month follow up
Awards & highlights

CHAMPS Trial Summary

This trial is testing a combined community health worker and smartphone intervention linked to a smart pill box for antiretroviral adherence in HIV positive people in the United States. The goal is to see if this intervention enables people to self-manage their antiretroviral regimens while CHW monitor their adherence in real-time, ultimately leading to viral suppression and adherence.

Who is the study for?
This trial is for people living with HIV who speak English or Spanish, have been diagnosed over 6 months ago, and are struggling with their treatment. They should have a viral load above 200 copies/mL, missed clinic visits, or reported being virally unsuppressed in the past year. Participants must own a smartphone and be willing to try any part of the study.Check my eligibility
What is being tested?
The CHAMPS intervention combines community health worker support and a smartphone app linked to a smart pill box to help participants manage their HIV treatment better. The goal is to improve medication adherence and achieve viral suppression through real-time monitoring.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial focuses on adherence support rather than new medications. However, increased attention on medication schedules could cause stress or anxiety for some individuals.

CHAMPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with HIV more than 6 months ago.

CHAMPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow up, 12 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow up, 12 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Viral Load
Secondary outcome measures
Change in ART adherence - CleverCap
Change in Score on the Self-Rating Scale Item (SRSI)

CHAMPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Wise App that delivers medication adherence reminders and community health worker sessions
Group II: ControlActive Control1 Intervention
Standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CHW Sessions
2023
N/A
~40
Wise App with medication adherence reminders
2023
N/A
~40

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,448,519 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
584 Previous Clinical Trials
10,378,987 Total Patients Enrolled
Rebecca Schnall, PhD, MPH, RNPrincipal Investigator - Columbia University
Columbia University
3 Previous Clinical Trials
131 Total Patients Enrolled

Media Library

CHW Sessions Clinical Trial Eligibility Overview. Trial Name: NCT04562649 — N/A
HIV/AIDS Research Study Groups: Control, Intervention
HIV/AIDS Clinical Trial 2023: CHW Sessions Highlights & Side Effects. Trial Name: NCT04562649 — N/A
CHW Sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562649 — N/A
~0 spots leftby Jun 2024
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