Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04562649|
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Device: Wise App with medication adherence reminders Behavioral: CHW Sessions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Community Health Worker And MHealth to ImProve Viral Suppression|
|Actual Study Start Date :||May 3, 2021|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Wise App that delivers medication adherence reminders and community health worker sessions
Device: Wise App with medication adherence reminders
The Intervention group will receive the Wise App that delivers medication adherence reminders.
Behavioral: CHW Sessions
The Intervention group will complete sessions with a community health worker (CHW).
No Intervention: Control
Standard of care
- Change in Viral Load [ Time Frame: Baseline, 6 month follow up, 12 month follow up ]Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.
- Change in ART adherence - CleverCap [ Time Frame: 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 it is a count response (number of times taking medication each day).
- Change in Score on the Self-Rating Scale Item (SRSI) [ Time Frame: 6 month follow up, 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562649
|Contact: Rebecca Schnall, PhD, MPH, RNfirstname.lastname@example.org|
|Contact: Olivia Woodemail@example.com|
|United States, Alabama|
|Birmingham AIDS Outreach||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Emma Kay, PhD, MSW 205-322-4197 firstname.lastname@example.org|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: David Batey, PhD, MSW 205-934-5266 email@example.com|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Rebecca Schnall, PhD, MPH, RN 212-342-6886 firstname.lastname@example.org|
|Contact: Olivia Wood 212-305-8198 email@example.com|
|Principal Investigator:||Rebecca Schnall, PhD, MPH, RN||Columbia University|