Mobile Health Messaging for HIV/AIDS

Overseen By Lunthita M Duthely, Ed.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Men, Cognitive impairment, Adolescents, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health messaging system (Mobile Health Messaging application) designed to help women with HIV adhere to their treatment plans. The system sends reminders about appointments, prescriptions, and medication, and addresses challenges such as stigma or mistrust of the medical system. Participants will either receive standard care or additional support through this messaging system and patient navigation. Women who have faced issues like missed appointments or detectable viral loads (amount of HIV in the blood) may be well-suited for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative solutions that could enhance adherence to HIV treatment plans.

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 prior data suggests that this mobile health messaging application is safe for use in HIV care?

Research has shown that mobile health messages, like those in this study, are generally safe. Studies have found that mobile reminders can help people with HIV adhere better to their treatment plans. For example, one study found that these messages helped patients take their medication on time more often. Another study showed that the messages helped patients keep up with their appointments and prescriptions.

No reports indicate harmful side effects from using mobile health messages. These messages are designed to remind and support, not to act as medication or physical treatment. Participants usually handle them well. If considering joining this trial, there is no evidence suggesting any safety concerns from using the mobile health messaging system itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Messaging treatment for HIV/AIDS because it offers a new way to support patients through digital engagement. Unlike standard treatments that primarily focus on medications like antiretrovirals, this approach uses a mobile health application to deliver psycho-educational messages, providing ongoing support and education right at a patient’s fingertips. This method could improve patient adherence to medication and overall health outcomes by offering personalized, real-time guidance and navigation assistance, making it a unique complement to traditional care.

What evidence suggests that the Mobile Health Messaging application could be effective for HIV care?

Research has shown that mobile health tools, such as text message reminders, can help people with HIV adhere to their antiretroviral therapy (ART) medication schedule. In this trial, participants in the Mobile Health Messaging Arm will receive standard care, patient navigation assistance, and the mobile health intervention, which includes psycho-educational messaging. One study found that SMS reminders improved medication adherence among HIV patients. A review of several studies also found that text messages significantly helped young people with HIV adhere to their ART regimen. Additionally, these mobile health tools can enhance the overall well-being of people living with HIV by addressing challenges like stigma and distrust in medical care, making them a valuable component of HIV treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Lunthita M Duthely, Ed.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Mobile Health Messaging Arm Experimental Treatment 2 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 Arm Active Control 1 Intervention

The control arm will receive standard of care.

Group III: Focus Group Arm Active Control 1 Intervention

The results of the focus groups will contribute to the wording and design of the intervention.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

This study aims to evaluate the effectiveness of different reminder methods (text messages, reminder calls, or both) in increasing the use of service referrals among 300 participants from community outreach programs.

The research will help determine how mobile phone-based interventions can enhance community engagement and service utilization, potentially guiding future reminder protocols for similar programs across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. Varma, DS., Hart, M., McIntyre, DS., et al.[2020]

Health literacy is crucial for the effective design and use of mHealth applications, as many users struggle to understand health information provided by these tools, especially when they are unwell.

To improve health promotion outcomes, mHealth applications must be tailored to match the communication needs and literacy levels of diverse audiences, ensuring that messages are clear and actionable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relevance of Health Literacy to mHealth. Kreps, GL.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study analyzed 1550 SMS messages and 4071 participant replies, finding that supportive and informative messages significantly reduced the likelihood of participants prematurely stopping the program, while notification messages increased the chance of stopping.

Machine learning models effectively categorized message intent and participant replies, showing that informative and instructional messages boosted engagement, while motivational messages did not have a significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Analysis Using Machine Learning to Assess Predictors of Engagement With Mobile Health Chronic Disease Prevention Programs: Content Analysis. Klimis, H., Nothman, J., Lu, D., et al.[2022]

The pager-based text messaging system was generally well-received by participants, effectively reminding them to take their medication, but had a low overall message response rate of 42.8% that decreased significantly over the 3-month study period.

User engagement with the messaging system did not vary significantly across different demographic and psychosocial groups, suggesting that future improvements may require customization of notification styles and frequencies to enhance adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-way text messaging for health behavior change among human immunodeficiency virus-positive individuals. Harris, LT., Lehavot, K., Huh, D., et al.[2022]

In a trial involving 200 HIV-positive adults in Cameroon, motivational text messages sent weekly did not significantly improve adherence to antiretroviral therapy (ART) over six months, as measured by various adherence metrics.

Despite the lack of significant improvement in adherence, the study suggests exploring different messaging strategies or longer study durations to potentially enhance ART adherence in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cameroon Mobile Phone SMS (CAMPS) trial: a randomized trial of text messaging versus usual care for adherence to antiretroviral therapy. Mbuagbaw, L., Thabane, L., Ongolo-Zogo, P., et al.[2022]

A qualitative study involving 26 adults living with HIV/AIDS in Lima, Peru found that patients positively view SMS reminders for antiretroviral therapy adherence, emphasizing the need for simplicity and conciseness in the messages.

Participants highlighted the importance of maintaining confidentiality in SMS reminders by using coded language instead of direct references to HIV or antiretroviral therapy, indicating a preference for privacy in their healthcare communications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's time for your life": How should we remind patients to take medicines using short text messages? Curioso, WH., Quistberg, DA., Cabello, R., et al.[2021]

The SMS intervention for managing HIV Viral Load results in Zimbabwe was found to be acceptable to both patients and healthcare workers, improving adherence and management of results despite some implementation challenges.

While the intervention has the potential to reduce unnecessary clinic visits and enhance patient engagement in their HIV care, it requires clear communication and counseling to address concerns about message clarity and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. Venables, E., Ndlovu, Z., Munyaradzi, D., et al.[2020]

The iReach randomized controlled trial successfully identified and prevented 624 cases of potential fraudulent or ineligible enrollment among same-sex attracted, cisgender males aged 13-18, using a combination of electronic and manual authentication strategies.

79% of these cases were detected through electronic methods, highlighting the effectiveness of technology in maintaining data integrity and reducing the need for extensive manual reviews in web-based trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. Guest, JL., Adam, E., Lucas, IL., et al.[2021]

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