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

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 2 9 10 11}

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 interviewing 2) 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

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.

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

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. England 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. [2022]

3. England 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. [2022]

4. Canada 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. [2020]

5. United States 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The Relevance of Health Literacy to mHealth. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. [2021]

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

Two-way text messaging for health behavior change among human immunodeficiency virus-positive individuals. [2022]

9. Canada 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. [2022]

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

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. [2020]

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

"It's time for your life": How should we remind patients to take medicines using short text messages? [2021]