Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
A-TEAM
BehavioralParticipants 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: A-TEAMExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Viral load suppression
We measure HIV viral load
Time frame
At 6 months after introduction of the intervention.Secondary outcomes
1
Adherence
Real-time and self-reported adherence
Time frame
At the end of month 1, month 2, month 3, month 4, month 5 and at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov