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Active Not Recruiting NCT06550804

Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

Conditions: HIV Infections, Adherence, Medication

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 126
Sponsor: University of Illinois at Chicago

Location: University of Illinois Chicago Chicago Illinois

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 \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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06550804). StuddyBuddy aggregates publicly available trial information.