mHealth Facilitated Intervention for HIV/AIDS
(Super SMART Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, since the study focuses on improving adherence to HIV medications, it is likely that you will continue taking your prescribed HIV medications.
What data supports the effectiveness of the mHealth Facilitated Intervention for HIV/AIDS treatment?
Research shows that mobile health (mHealth) tools can help people with HIV by improving their connection to care, keeping them engaged in treatment, and helping them stick to their medication schedule. These tools can send reminders, collect data, and provide educational messages, which have shown positive outcomes in small studies.12345
How is the Carium Mobile Health Platform treatment for HIV/AIDS different from other treatments?
The Carium Mobile Health Platform is unique because it uses mobile health technology to support HIV/AIDS care, offering features like alerts, reminders, and educational messaging to improve adherence to treatment and retention in care, which is different from traditional medication-based treatments.12467
Eligibility Criteria
This trial is for adults over 18 living with HIV who have not been fully adhering to their ART medication and have had a detectable viral load in the past 6 months. It's not suitable for those with physical or cognitive impairments, active psychosis, or non-English speakers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline interviews and receive initial health coaching session
Intervention
Participants receive health coaching and access to a smartphone application for medication adherence support
Follow-up
Participants are monitored for ART adherence and viral load data through follow-up interviews
Extended Follow-up
A subset of participants complete additional follow-up interviews to assess sustained intervention effects
Treatment Details
Interventions
- Carium Mobile Health Platform
- Face-to-Face ART Adherence Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rhode Island Hospital
Lead Sponsor
Emory University
Collaborator