Pilot Trial of a Real-time Electronic Adherence Monitoring Intervention for Antiretroviral Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The investigators propose using an electronic adherence device that is basically a pill container that can alert when it is not opened at a scheduled time. The investigators will use this device to alert the medication user at the time when medication is supposed to be taken if the device did not get opened and a pre-identified social support person or case manager when 2 or 7 consecutive days of nonadherence are detected, respectively. The investigators call our approach A-Team (Antiretroviral Therapy Electronic Adherence Monitoring). The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of African American Men who have sex with Men and to test this approach for these men in a 6-month randomized controlled trial among 54 of these men living with HIV and measure ART adherence and viral suppression (the primary outcome).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Participant inclusion criteria:

• AAMSM \>18 years with self-reported HIV infection;

• own a working cell phone;

• on ART for at least 6 months;

• have a case manager willing to participate in the study (for the clinical trial); and

• have suboptimal adherence - either have a detectable viral load in the past 6 months, self-reported \<90% adherence based on a 3-item measure or referral by their healthcare provider because of a recognized problem with ART adherence.

⁃ For social support persons, participants will:

• report that they have a self-described meaningful relationship with the participant;

• be \>18 years of age;

• own a working cell phone and;

• be willing to provide support.

⁃ For case managers, participants will have worked with clients with HIV at least 6 months prior to their participation in this study and own a working cell phone.

Locations
United States
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Contact Information
Primary
Mark Dworkin, MD
mdworkin@uic.edu
3124130348
Backup
Anita Shaperd, MPH
anshap@uic.edu
3123554667
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 126
Treatments
Experimental: A-TEAM
This arm receives the A-TEAM approach where the men, their social support (if they have one), and their case manager participate. If the adherence device identifies non-opening of the device, the men are alerted by text or email the same day. If the device identifies non-opening of the device two days in a row, the social support (or case manager) is notified, and if 7 days of non-opening is detected, the case manager is notified.
No_intervention: Control
The men are monitored with the adherence device but there is no intervention on their adherence - they otherwise experience routine care and they don't receive alerts if they the device detects non-openings.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago
Collaborators: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov