400 Participants Needed

mHealth Facilitated Intervention for HIV/AIDS

(Super SMART Trial)

Recruiting at 1 trial location
SR
Overseen BySusan Ramsey, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rhode Island Hospital
Must be taking: ART
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I have been diagnosed with HIV.
I am currently taking antiretroviral therapy.
detectable viral load (>20 copies/mL) in past 6 months
See 2 more

Exclusion Criteria

I understand the details of the clinical trial and can make informed decisions.
I do not have physical impairments that would stop me from completing the treatment.
You have a mental condition that is currently causing hallucinations or delusions.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline interviews and receive initial health coaching session

1 day
1 visit (in-person)

Intervention

Participants receive health coaching and access to a smartphone application for medication adherence support

12 months
Remote access via app

Follow-up

Participants are monitored for ART adherence and viral load data through follow-up interviews

12 months
Interviews at 1, 3, 6, 12 months

Extended Follow-up

A subset of participants complete additional follow-up interviews to assess sustained intervention effects

12 months
Interviews at 18, 24 months

Treatment Details

Interventions

  • Carium Mobile Health Platform
  • Face-to-Face ART Adherence Intervention
Trial OverviewThe study tests if a health coaching session combined with a mobile app that reminds patients to take their HIV medication and allows remote access to a health coach can improve adherence compared to just having the health coaching session.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: mHealth Facilitated Adherence CoachingExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Findings from Research

The study involved focus groups with 5 people living with HIV and 9 healthcare professionals, highlighting the need for improved information, disease awareness, and medication dispensation models in HIV care.
The new mHealth app, designed based on user feedback, aims to enhance patients' quality of life, medication adherence, and disease control through features like disease information, health promotion, and improved communication with healthcare providers.
Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study.De Dios, A., Masip, M., Pagรจs-Puigdemont, N., et al.[2022]
Mobile health technology (mHealth) shows promise in supporting key aspects of HIV care, such as linking patients to care, retaining them in treatment, and improving adherence to antiretroviral therapy, based on a systematic review of 62 articles.
Despite the rapid evolution of mHealth tools, there is still a lack of rigorous evidence specifically addressing the needs of vulnerable populations, indicating a need for more targeted research and implementation in these groups.
mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature.Catalani, C., Philbrick, W., Fraser, H., et al.[2022]
A mobile health app was developed specifically for older Black women with HIV, based on qualitative feedback from 10 participants aged 50 and older, highlighting their needs and preferences.
The app aims to enhance support and resources for this demographic, and its development involved community input, indicating a collaborative approach to addressing the unique challenges faced by older women living with HIV.
Leveraging Community Engagement to Develop a Mobile Health Application for Older Women With HIV Infection.Njie-Carr, VPS., Jones-Parker, H., Massey, C., et al.[2022]

References

Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study. [2022]
2.United Arab Emiratespubmed.ncbi.nlm.nih.gov
mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature. [2022]
Leveraging Community Engagement to Develop a Mobile Health Application for Older Women With HIV Infection. [2022]
Exploring the equity impact of mobile health-based human immunodeficiency virus interventions: A systematic review of reviews and evidence synthesis. [2022]
An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. [2021]
Mobile health applications for HIV prevention and care in Africa. [2017]
Retention in an mHealth App Aiming to Promote the Use of HIV Pre-Exposure Prophylaxis Among Female Sex Workers in Dar es Salaam, Tanzania: Prospective Cohort Study. [2023]