Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention (A-TEAM)

Pilot Trial of a Real-time Electronic Adherence Monitoring Intervention for Antiretroviral Therapy

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).

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Adherence, Medication
• Intervention / Treatment: Behavioral: A-TEAM

Detailed Description

African American men who have sex with men (AAMSM) have high HIV infection rates and disproportionate mortality. Critical to ending the HIV epidemic are efforts to reduce HIV transmission by optimizing antiretroviral adherence and suppressing viral load. The investigators propose using responsive electronic adherence monitoring (EAM) in a tiered approach from least to most resource utilization where the EAM device alerts the medication user at the time non-adherence is detected 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) because we provide a team serving a common goal to persons struggling with adherence. This intervention draws on the situated Information Motivation Behavioral Skills Model and is informed by emerging social support literature. Real-time ART adherence monitoring with a triaged response to missed doses informs the patient in real-time of each potential non-adherence event, motivates medication adherence, and positively influences adherence behavioral skills, resulting in viral suppression. This study will be the first to discover how social support persons and case managers perceive this approach, what concerns they may have, and how they respond to one or multiple notifications of missed doses. The aims of this application are to determine the acceptability and feasibility of real-time adherence monitoring in support persons and case managers of AAMSM and to pilot a triaged responsive real-time monitoring adherence intervention for AAMSM. The investigators will implement a 6-month pilot randomized controlled trial among 54 AAMSM living with HIV and measure ART adherence and viral suppression (the primary outcome). Lessons learned from this project may be useful to the field of adherence in these and other persons living with HIV and other diseases.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mark Dworkin, MD; Phone Number: 3124130348; Email: mdworkin@uic.edu
• Study Contact Backup: Name: Anita Shaperd, MPH; Phone Number: 3123554667; Email: anshap@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Mark Dworkin, MD; Phone Number: 312-413-0348; Email: mdworkin@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load suppression	We measure HIV viral load	At 6 months after introduction of the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Real-time and self-reported adherence	At the end of month 1, month 2, month 3, month 4, month 5 and at 6 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Mark Dworkin, MD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 2023-0873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As individual participant data might contain identifiers since some data is qualitative, we are undecided on how to share data and will seek guidance if the situation arises.
• IPD Sharing Time Frame: Data will be available for one year after the pilot trial efficacy data are published in a peer-reviewed journal.
• IPD Sharing Access Criteria: Contact principal investigator with rationale and plan
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No