Recruiting

mHealth Intervention

Sponsor:

Rhode Island Hospital

Code:

NCT05046392

Conditions

HIV

Medication Adherence

Telemedicine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Face-to-Face ART Adherence Intervention

Carium Mobile Health Platform

Study Details

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

Study ID

NCT05046392

Start date

Oct 6, 2021

Status verified date

Apr, 2023

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mHealth Facilitated Adherence Coaching

active comparator: Control

Interventions

Face-to-Face ART Adherence Intervention

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.

Carium Mobile Health Platform

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.

Primary outcome measure

  • Electronic Pillbox ART Adherence [ Time Frame: 12 Months ]
  • HIV Viral Load [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

More Information

Sponsor

Rhode Island Hospital

Last update posted

Apr 5, 2023

Last verified

Apr, 2023

Keywords

  • HIV
  • Medication Adherence
  • mHealth
  • Health Coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2023-04-05.