Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06550804
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • A-TEAM — BEHAVIORAL
    Participants randomized to the intervention arm will receive the proposed intervention, which involves an electronic adherence device called Wisepill and triaged text alerts to the user, the social support, and the case manager for same day, two day, and seven day device non-openings.

Study Details

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 Dates

Start date
Oct 1, 2024
Status verified
Nov 2024
Primary completion
Feb 28, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: A-TEAM
    This arm receives the A-TEAM approach where the men, their social support (if they have one), and their case manager participate. If the adherence device identifies non-opening of the device, the men are alerted by text or email the same day. If the device identifies non-opening of the device two days in a row, the social support (or case manager) is notified, and if 7 days of non-opening is detected, the case manager is notified.
  • No Intervention: Control
    The men are monitored with the adherence device but there is no intervention on their adherence - they otherwise experience routine care and they don't receive alerts if they the device detects non-openings.

Primary Outcome Measure

Viral load suppression [ Time Frame: At 6 months after introduction of the intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612
Mark Dworkin, MD
[email protected]
312-413-0348

Find similar trials in Chicago, IL

By condition
HIV
By specialty
Infectious disease
By research site
University of Illinois Chicago· Chicago, IL

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