80 Participants Needed

Mobile Health Messaging for HIV/AIDS

AB
LM
Overseen ByLunthita M Duthely, Ed.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on helping you stick to your existing HIV treatment plan.

What data supports the effectiveness of the Mobile Health Messaging application treatment for HIV/AIDS?

Research shows that using mobile text reminders can help people with HIV stick to their medication schedule and improve their quality of life. Text messaging has been effective in reminding patients to attend appointments and adhere to treatments, leading to better health outcomes.12345

Is mobile health messaging safe for use in humans?

Research indicates that mobile health messaging, such as text message reminders, is generally safe for humans. There have been no reports of adverse events related to misreading or misinterpreting data, privacy issues, or message delivery failures.14678

How is the Mobile Health Messaging application treatment different from other HIV/AIDS treatments?

The Mobile Health Messaging application is unique because it uses text messages to remind patients to take their medication and attend appointments, which can improve adherence to treatment and overall health outcomes. Unlike traditional treatments that focus solely on medication, this approach leverages mobile technology to support behavior change and enhance patient engagement.1291011

What is the purpose of this trial?

The purpose of this study is:1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).2. The intervention will also include patient navigation and motivational interviewing2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.

Research Team

LM

Lunthita M Duthely, Ed.D.

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for women over 18 with HIV who have missed appointments, had a detectable viral load, or haven't taken their meds as prescribed. They must be currently in care or recently back in care and own a working cell phone. It's not for men, those under 18, cognitively impaired individuals unable to consent, or without a cell phone.

Inclusion Criteria

Confirmed HIV diagnosis as per the clinic standard
In the 12 months prior to enrollment: missed one or more visits or viral load detectable (>20 mL) or not taking prescribed HIV anti-retroviral medications
I am a woman aged 18 or older.
See 3 more

Exclusion Criteria

Non-working cell phone
I am unable to make medical decisions for myself due to cognitive impairment.
I am under 18 years old.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive mobile health messaging and patient navigation to improve treatment adherence and address barriers to HIV care

12 months
Ongoing virtual interactions

Follow-up

Participants are monitored for changes in clinic attendance, stigma, medical mistrust, and resilience

4 weeks

Treatment Details

Interventions

  • Mobile Health Messaging application
  • Standard of Care Treatment
Trial Overview The study is testing an mHealth system that sends text messages to help women with HIV stick to their treatment plans. The goal is to see if this method helps patients keep up with appointments, refill prescriptions on time, take medication regularly and overcome barriers like stigma.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Health Messaging ArmExperimental Treatment2 Interventions
The Patient Navigation and Mobile Health Messaging Arm will receive standard of care, as well as patient navigation assistance and the mobile health intervention. The mHealth intervention includes psycho-educational messaging as well.
Group II: Control ArmActive Control1 Intervention
The control arm will receive standard of care.
Group III: Focus Group ArmActive Control1 Intervention
The results of the focus groups will contribute to the wording and design of the intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

A review of 51 studies highlighted the importance of developing SMS content for mHealth initiatives aimed at supporting HIV/AIDS treatment adherence, emphasizing the need for formative research and grounding messages in behavior change theory.
Best practices for creating effective SMS messages include consulting with experts and using established behavior change frameworks to enhance the effectiveness of mobile health interventions in resource-limited settings.
Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature.Kerrigan, A., Kaonga, NN., Tang, AM., et al.[2023]
A systematic review of ten randomized control trials involving 1621 participants found that mobile text reminders (SMS) significantly improved adherence to antiretroviral therapy (ART) in people living with HIV/AIDS, although some studies were underpowered.
There is currently insufficient evidence to support the effectiveness of SMS interventions in improving physical exercise adherence or quality of life, highlighting a need for more robust studies in these areas.
Effectiveness of mobile text reminder in improving adherence to medication, physical exercise, and quality of life in patients living with HIV: a systematic review.Ibeneme, SC., Ndukwu, SC., Myezwa, H., et al.[2022]
Text messaging interventions have been shown to effectively improve adherence to antiretroviral therapy and increase appointment attendance among people living with HIV, based on a systematic review of nine high-quality reviews involving 37 studies across 19 countries.
There are significant knowledge gaps regarding long-term outcomes and patient satisfaction with text messaging interventions, indicating a need for further research to fully understand their impact and potential in managing other chronic diseases.
Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer.Mbuagbaw, L., Mursleen, S., Lytvyn, L., et al.[2022]

References

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. [2023]
Effectiveness of mobile text reminder in improving adherence to medication, physical exercise, and quality of life in patients living with HIV: a systematic review. [2022]
Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. [2022]
A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. [2020]
The Cameroon Mobile Phone SMS (CAMPS) trial: a randomized trial of text messaging versus usual care for adherence to antiretroviral therapy. [2022]
The Relevance of Health Literacy to mHealth. [2018]
Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. [2021]
Two-way text messaging for health behavior change among human immunodeficiency virus-positive individuals. [2022]
Text Message Analysis Using Machine Learning to Assess Predictors of Engagement With Mobile Health Chronic Disease Prevention Programs: Content Analysis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
"It's time for your life": How should we remind patients to take medicines using short text messages? [2021]
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