Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able to speak, read, and write in English;
Be above 18 years of age;
Be willing to participate in any assigned arm of the intervention;
Have an HIV-1 RNA level >200 copies/mL;
Disqualifiers
Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
Terminal illness with life expectancy <6 months; and
Planning to move out of the area in the next 12 months.
Trial design
Design model
Parallel
Treatments tested in this trial
CHW Sessions
BehavioralSessions with a Community Health Worker (CHW)
CleverCap
DeviceThe CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Intervention CHAMPS+Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Viral Load
Using blood samples obtained during standard of care visits, viral load levels will be used to asses ART adherence.
Time frame
Baseline, 6 month follow up, 12 month follow up.Secondary outcomes
1
Change in ART adherence - CleverCap.
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data from participants in the intervention arm 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).
Time frame
Up to 12 months.2
Change in Score on the Self-Rating Scale Item (SRSI).
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. The total score range is 1(very poor) to 6 (excellent). A higher score indicates higher self-reported adherence.
Time frame
Baseline, 6 month follow up, 12 month follow up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
University of Alabama at Birmingham
Collaborator
Health Services Center, Inc.
Collaborator
Unity Wellness Center
Collaborator
Louisiana State University Health Sciences Center in New Orleans
Collaborator
University of Mississippi Medical Center
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Tulane University
Collaborator
Source ClinicalTrials.gov