Real-time electronic monitoring for HIV medication adherence

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

This study tests a new electronic device that helps African American men with HIV remember to take their medication on time and see if it improves their health over six months.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06550804 on ClinicalTrials.gov

What this trial studies

This study evaluates an electronic adherence device designed to monitor and improve medication adherence among African American men who have sex with men living with HIV. The device alerts users when they miss a scheduled medication dose and notifies a designated support person or case manager after consecutive days of non-adherence. The intervention, termed 'A-Team', aims to enhance adherence through real-time feedback and social support, ultimately measuring its impact on viral suppression over a 6-month period in a randomized controlled trial involving 54 participants. The study seeks to assess both the acceptability and feasibility of this approach in the target population.

Who should consider this trial

Good fit: Ideal candidates include African American men who have sex with men, over 18 years old, with self-reported HIV infection and suboptimal adherence to antiretroviral therapy.

Not a fit: Patients who do not have a meaningful relationship with a support person or case manager, or those who do not meet the inclusion criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve medication adherence and viral suppression among individuals living with HIV.

How similar studies have performed: Previous studies have shown promise in using electronic adherence monitoring for improving medication adherence, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

* 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 this trial is running

Chicago, Illinois

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

Study contacts

• Principal investigator: Mark Dworkin, MD — University of Illinois at Chicago
• Study coordinator: Mark Dworkin, MD

Conditions HIV Infections; Adherence, Medication