NCT06550804 Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
| NCT ID | NCT06550804 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Illinois at Chicago |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 126 participants in total. It began in 2024-10-01 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mark Dworkin, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT06550804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06550804 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 126 participants.
Is NCT06550804 currently recruiting?
Yes, NCT06550804 is actively recruiting participants. Contact the research team at mdworkin@uic.edu for enrollment information.
Where is the NCT06550804 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06550804 clinical trial?
NCT06550804 is sponsored by University of Illinois at Chicago. The principal investigator is Mark Dworkin, MD at University of Illinois at Chicago. The trial plans to enroll 126 participants.
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