NCT06550804 · University of Illinois at Chicago
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
(A-TEAM)
What this study is about
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.
View original scientific description
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).
Interventions
BEHAVIORAL
A-TEAM
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.
Primary outcome measures
Viral load suppression
Time frame: At 6 months after introduction of the intervention.
We measure HIV viral load
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Collaborators
Massachusetts General Hospital
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2024 · Source of record for eligibility and locations