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

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

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.

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 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.

Participant Groups

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+

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.

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]

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]

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]

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Developing a mHealth intervention to redesign the current journey for people living with HIV: A qualitative study. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Leveraging Community Engagement to Develop a Mobile Health Application for Older Women With HIV Infection. [2022]

4. United States 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. [2022]

5. Canada 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mobile health applications for HIV prevention and care in Africa. [2017]

7. Canada 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. [2023]