RecruitingPhase 3NCT06550804

Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

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

Sponsor

University of Illinois at Chicago

Enrollment

126 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections Adherence, Medication

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a real-time electronic monitoring system to help Black and African American men who have sex with men (AAMSM) who are living with HIV take their antiretroviral therapy (ART) medications more consistently. The system monitors pill-taking electronically and alerts case managers and/or supportive social contacts when doses are missed, aiming to improve medication adherence and reduce viral load. **You may be eligible if...** - You are a Black or African American man who has sex with men (AAMSM), over 18 years old - You are living with HIV - You have been on antiretroviral therapy (ART) for at least 6 months - You have suboptimal adherence — defined as a detectable viral load in the past 6 months, or self-reporting less than 90% adherence, or your provider flagged adherence as a problem - You own a working cell phone - You have a case manager willing to participate (for the clinical trial arm) **You may NOT be eligible if...** - You do not have a cell phone - You have been on ART for less than 6 months - You are not in the target demographic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALA-TEAM

Participants randomized to the intervention arm will receive the proposed intervention, which involves an electronic adherence device called Wisepill and triaged text alerts to the user, the social support, and the case manager for same day, two day, and seven day device non-openings.