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Behavioral Intervention

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

N/A

Recruiting

Led By Scott Batey, PhD, MSW

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 baseline, 6 month follow up, 12 month follow up.

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 month follow up, 12 month follow up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 month follow up, 12 month follow up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention CHAMPS+Experimental Treatment2 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

0 / 1Eligibility criteria met