NCT06550804Active, not recruitingPhase 3
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
Pilot Trial of a Real-time Electronic Adherence Monitoring Intervention for Antiretroviral Therapy
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 5 Jul 2024
- Start date
- 1 Oct 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- University of Illinois Chicago
- Diseases
- HIV
- NCT number
- NCT06550804
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 126
- From 1 Oct 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Not meeting the inclusion criteria
- Not agreeing to informed consent concerning interactions with research team, data collection, and access to medical records.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.