Clinical trial NCT06550804: Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
Official title: Pilot Trial of a Real-time Electronic Adherence Monitoring Intervention for Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HIV Infections
Adherence, Medication
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2024-08-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives intervention and one groups receives routine care only.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Viral load suppression
timeFrame: At 6 months after introduction of the intervention.
Secondary outcomes:
measure: Adherence
timeFrame: At the end of month 1, month 2, month 3, month 4, month 5 and at 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Mark Dworkin, MD
role: PRINCIPAL_INVESTIGATOR
References: