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Behavioral Intervention

Community Health Workers and mHealth for HIV/AIDS (CHAMPS+ Trial)

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

Summary

This trial aims to improve HIV treatment and control in the Deep South of the United States, where people with HIV face challenges in accessing healthcare. Researchers have developed an intervention called CHAMPS that uses mobile

Who is the study for?
The CHAMPS+ trial is for people living with HIV/AIDS in the Deep South of the US who are struggling with ART adherence and viral suppression. Participants should be willing to use mHealth technology and work with community health workers.
What is being tested?
CHAMPS+ aims to improve ART adherence and viral load suppression among HIV patients using a combination of mobile health tech (WiseApp, CleverCap) and support from community health workers, including risk reduction counseling.
What are the potential side effects?
Since this trial focuses on behavioral interventions like counseling sessions and app usage rather than medications, traditional side effects are not expected. However, participants may experience stress or discomfort discussing personal health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.

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

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention CHAMPS+Experimental Treatment3 Interventions
Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.
Group II: ControlActive Control1 Intervention
The control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CHW Sessions
2021
N/A
~340

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamOTHER
1,621 Previous Clinical Trials
2,290,558 Total Patients Enrolled
Unity Wellness CenterUNKNOWN
Louisiana State University Health Sciences Center in New OrleansOTHER
119 Previous Clinical Trials
44,408 Total Patients Enrolled
~280 spots leftby Jul 2027
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