Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention

NCT06550804 | Recruiting Phase 3 DMC

• 1 other identifier: 2023-0873
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV Infections; Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• Viral load suppression

  We measure HIV viral load

  At 6 months after introduction of the intervention.

Secondary Outcomes (1)

• Adherence

  At the end of month 1, month 2, month 3, month 4, month 5 and at 6 months

Study Arms (2)

A-TEAM

EXPERIMENTAL

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.

Behavioral: A-TEAM

Control

NO INTERVENTION

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.

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.

A-TEAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mark Dworkin, MD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Dworkin, MD

CONTACT

3124130348; mdworkin@uic.edu

Anita Shaperd, MPH

CONTACT

3123554667; anshap@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group receives intervention and one groups receives routine care only.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: August 13, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available for one year after the pilot trial efficacy data are published in a peer-reviewed journal.
• Access Criteria: Contact principal investigator with rationale and plan

Locations

US (1)