mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV

NCT05046392 | Unknown DMC

• 1 other identifier: R01MH125796
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

HIV medications can be very effective at helping patients have longer, healthier lives. However, many patients do not take their HIV medications as prescribed. This study aims to test a promising HIV medication adherence health coaching intervention delivered primarily via a smartphone application. N = 400 persons living with HIV will be enrolled across two sites (Providence, RI \& Atlanta, GA). Participants will be randomly assigned, with a 2:1 ratio, to receive a 1) health coaching session with access to a smartphone application that provides medication reminders and remote access to the health coach or a 2) health coaching session only. Participants will complete interviews at baseline, 1, 3, 6, and 12 months after baseline. Some participants will also complete interviews at 18 and 24 months after baseline. Data analysis will examine the extent to which the intervention improves ART medication adherence, as well as other factors, compared to the control condition, which approximates standard of care.

Conditions

HIV; Medication Adherence; Telemedicine

Keywords

HIV; Medication Adherence; mHealth; Health Coaching

Outcome Measures

Primary Outcomes (2)

• Electronic Pillbox ART Adherence

  ART adherence will be measured objectively with an electronic pillbox. In this study, the electronic pillbox will be a MEMS Cap. The MEMS Cap is a battery operated electronic bottle cap that is affixed to a pill bottle and records the date and time a patient opens their bottle but provides no feedback or reminders. Participants will be given a MEMS Cap and instructions on how to use it at the baseline interview. Data will be downloaded from the MEMS Cap at all proceeding study visits.

  12 Months

• HIV Viral Load

  HIV viral load data will be extracted from participants' medical record if it was performed as a part of clinical care prior to the study visit. Otherwise, viral load will be collected from laboratories at the study sites. All laboratories will use assays with sensitivity to detect viral load \> 20 copies/mL. For the 18- and 24-month follow-up, VL data will only be collected via medical record extraction.

  12 Months

Secondary Outcomes (5)

• ART Adherence Barriers

  Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

• HIV Treatment Adherence Self-Efficacy

  Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

• Substance Use

  Baseline, 1-, 3-, 6-, & 12-month follow-up interviews.

• Depressive Symptoms

  Baseline, 1-, 3-, 6-, & 12-month follow-up interviews.

• HIV Stigma

  Baseline, 1-, 3-, 6-, & 12-month follow-up interviews.

Other Outcomes (8)

• Self-Reported ART Adherence

  Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

• HIV Treatment Retention

  12- & 24- month follow-up interviews.

• Treatment Received

  Baseline, 1-, 3-, 6-, & 12-month follow-up interviews.

Study Arms (2)

mHealth Facilitated Adherence Coaching

EXPERIMENTAL

Behavioral: Face-to-Face ART Adherence Intervention; Behavioral: Carium Mobile Health Platform

Control

ACTIVE COMPARATOR

Behavioral: Face-to-Face ART Adherence Intervention

Interventions

Face-to-Face ART Adherence Intervention BEHAVIORAL

All participants will receive a one hour face-to-face session with an adherence coach, based on LifeSteps. The session will cover behavioral skills that are important for maintaining adherence to ART and will explore potential barriers for managing each skill. Cognitive-behavioral therapy, problem solving, and motivational interviewing techniques are used to explore barriers and create health goals.

Control; mHealth Facilitated Adherence Coaching

Carium Mobile Health Platform BEHAVIORAL

Participants assigned to the experimental condition will receive access to a mobile health app, called Carium, for 12 months. The app will be used to facilitate continued coaching from the adherence coach. The app incorporates automated medications reminders with interactive adherence coaching via a secure messaging feature. Participants will receive custom medication reminders as push notifications that will ask them to indicate if they have taken their medication or not. This will allow adherence coaches to monitor self-reported adherence in the app. Adherence coaches will use the secure messaging feature to check-in with participants and reach out to participants who appear to be struggling with adherence and offer assistance.

mHealth Facilitated Adherence Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• prescribed ART
• diagnosed with HIV
• detectable viral load (\>20 copies/mL) in past 6 months
• less than 100% self-reported medication adherence

You may not qualify if:

• physical impairments that would prevent completion of the intervention
• cognitive impairments that jeopardize informed consent and/or intervention comprehension
• active psychosis
• not fluent in English

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Emory University: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Susan Ramsey, PhD

CONTACT

(401) 444-7831; sramsey@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 16, 2021
• Study Start: October 6, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

US (2)