Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT06550804

Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

Led by University of Illinois at Chicago · Updated on 2024-11-21

126

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial 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. 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).

CONDITIONS

Official Title

Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • African American men who have sex with men (AAMSM) over 18 years old with self-reported HIV infection
  • Own a working cell phone
  • On antiretroviral therapy (ART) for at least 6 months
  • Have a case manager willing to participate (for the clinical trial)
  • Have suboptimal adherence indicated by detectable viral load in past 6 months, self-reported adherence below 90%, or healthcare provider referral due to adherence problems
  • Social support persons must have a meaningful relationship with the participant, be over 18, own a working cell phone, and be willing to provide support
  • Case managers must have worked with clients with HIV for at least 6 months and own a working cell phone
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Not agreeing to informed consent regarding interactions with the research team, data collection, and medical record access
  • Not consenting to provide viral load results from 12 months before and after study start to confirm eligibility and allow long-term follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Illinois Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

M

Mark Dworkin, MD

CONTACT

A

Anita Shaperd, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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