mHealth Facilitated Intervention for HIV/AIDS

(Super SMART Trial)

Recruiting at 1 trial location

Overseen By Susan Ramsey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must be taking: ART

Disqualifiers: Physical, cognitive impairments, active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with HIV adhere to their medication schedule using a smartphone app called the Carium Mobile Health Platform. The app sends reminders and enables users to communicate with a health coach remotely. The trial aims to determine if this approach improves medication adherence compared to standard health coaching without the app. Individuals with HIV who have been prescribed HIV medication and occasionally miss doses might be suitable for this study. As an unphased trial, participants can contribute to innovative research that may enhance medication adherence for many.

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 prior data suggests that this mHealth intervention is safe for improving medication adherence?

Research shows that the Carium Mobile Health Platform, a smartphone app aiding in HIV medication adherence, is generally safe. Previous studies have examined the effectiveness of health coaching in helping individuals maintain their medication schedules. These studies found that using a smartphone app for medication reminders is both practical and popular with users. No major safety issues have been reported with the app's use for this purpose.

Since this trial is labeled as "Not Applicable" for phase, it likely focuses on the app's effectiveness rather than testing a new drug. This means the primary concern is how well people can use the app, not its safety. So far, the app appears to be a safe tool for managing medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth Facilitated Intervention for HIV/AIDS because it uses the Carium Mobile Health Platform to enhance treatment adherence through mobile technology. Unlike traditional methods that rely on in-person consultations, this approach leverages a digital platform to provide real-time adherence coaching and support. This innovation aims to improve patient engagement and medication compliance, potentially leading to better health outcomes for individuals living with HIV/AIDS. By offering a more personalized and accessible means of support, this method could revolutionize how patients manage their condition.

What evidence suggests that this mHealth intervention is effective for improving HIV medication adherence?

Research has shown that mobile health tools, such as smartphone apps, can assist people with HIV in adhering to their medication regimens. In this trial, participants in the "mHealth Facilitated Adherence Coaching" arm will use the Carium Mobile Health Platform. This platform includes reminders and access to health coaches to support medication schedules. Early research indicates that this method is practical and well-received by patients, making it a promising way to enhance adherence to HIV treatment. By improving medication adherence, this approach can lead to better health outcomes for those living with HIV. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

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.

I am not fluent in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Carium Mobile Health Platform
• Face-to-Face ART Adherence Intervention

Trial Overview The 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.

How Is the Trial Designed?

Group I: mHealth Facilitated Adherence Coaching Experimental Treatment 2 Interventions

Group II: Control Active Control 1 Intervention

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 470 female sex workers in Dar es Salaam, Tanzania, only 13.4% continued to use the Jichunge mHealth app for PrEP adherence after 6 months, indicating significant challenges in retention.

Retention in the app was higher among older participants (≥35 years), those with greater awareness of PrEP, and individuals facing financial difficulties related to healthcare, suggesting that targeted strategies may be needed to improve long-term engagement with mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mbotwa, CH., Kazaura, MR., Moen, K., et al.[2023]

Mobile health (m-health) interventions for HIV prevention and care in Africa have been categorized into three main themes: patient-care applications, health system applications, and population health applications, highlighting the diverse uses of mobile technology in healthcare.

Despite the rapid adoption of smartphone technology, text messaging remains the most common method for delivering m-health interventions, indicating a need for broader evaluation methods beyond traditional randomized-controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health applications for HIV prevention and care in Africa. Forrest, JI., Wiens, M., Kanters, S., et al.[2017]

A systematic review of 19 reviews and 39 primary studies found that existing research on mobile health (mHealth) interventions for HIV treatment lacks adequate analysis of equity impacts, meaning we don't fully understand how these technologies affect different social groups.

While primary studies suggest that there may not be a significant social gradient in the effectiveness of mHealth interventions, overall evidence on the equity implications remains weak, limiting our ability to ensure these technologies reach those most affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the equity impact of mobile health-based human immunodeficiency virus interventions: A systematic review of reviews and evidence synthesis. Nittas, V., Ameli, V., Little, M., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature. Catalani, C., Philbrick, W., Fraser, H., et al.[2022]

The PositiveLinks (PL) mHealth app has shown promise in improving care engagement and viral load suppression among people with HIV, indicating its potential effectiveness as a supportive tool in chronic disease management.

An interim analysis of implementation at four Ryan White HIV clinics identified key facilitators, such as the app's alignment with clinic needs and effective training resources, as well as barriers like Wi-Fi access and patient privacy concerns, which will help optimize future implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. Cohn, WF., Canan, CE., Knight, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study. De Dios, A., Masip, M., Pagès-Puigdemont, N., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34117965/

A Preliminary Test of an mHealth Facilitated Health Coaching ... This study examined feasibility, acceptability, and preliminary efficacy of an mHealth facilitated health coaching antiretroviral therapy ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05046392/mhealth-facilitated-intervention-to-improve-medication-adherence-among-persons-living-with-hiv?page=9&id=417&slug=hiv

mHealth Facilitated Intervention to Improve Medication ... This study aims to test a promising HIV medication adherence health coaching intervention delivered primarily via a smartphone application. N = ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28639990/

Recent mobile health interventions to support medication ... Purpose of review: We describe recent mobile health (mHealth) interventions supporting antiretroviral therapy (ART) medication adherence among HIV-positive MSM.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05046392

mHealth Facilitated Intervention to Improve Medication ... This study aims to test a promising HIV medication adherence health coaching intervention delivered primarily via a smartphone application. ... Behavioral : ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04990583

mHealth Facilitated Intervention to Improve HIV Pre- ... The primary outcome is self-reported adherence to PrEP. This study will examine whether this intervention is effective at improving adherence to PrEP, is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8409010/

mHealth Interventions for Treatment Adherence and ... This review aims to synthesize existing literature on the patterns of use and effects of mHealth interventions for treatment adherence and outcomes of care for ...