Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

Recruiting now · Phase 3

Conditions studied: HIV Infections, Adherence, Medication

In brief

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).

Key facts

Study ID

NCT06550804

Run by

University of Illinois at Chicago

People needed

126

Starts

2024-10-01

Expected to finish

2026-07-01

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Not meeting the inclusion criteria
• Not agreeing to informed consent concerning interactions with research team, data collection, and access to medical records.
• Candidates must provide consent to obtain a copy of their viral load results during the 12 months before and following study onset to confirm eligibility and explore long-term follow-up of possible effect.

Where it is running

• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.