Text Message Education for Heart Disease in HIV/AIDS

Recruiting at 1 trial location

Overseen By Megan McLaughlin, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Ascvd, Pregnant, No smartphone, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

260 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with HIV (PLWH).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Digital Educational Messaging for heart disease in HIV/AIDS?

Research shows that text messaging interventions can improve health outcomes in people living with HIV and other chronic diseases. Additionally, educational text messages have been effective in promoting healthy behaviors and self-management in conditions like coronary heart disease. ^{1 2 3 4 5}

Is text message-based health education safe for humans?

Text message-based health education has been used safely in various programs, such as improving learning for midwives and providing health information to pregnant women and new mothers, without any reported safety concerns. ^{4 6 7 8 9}

How is the treatment of Digital Educational Messaging for heart disease in HIV/AIDS unique?

Digital Educational Messaging is unique because it uses text messages to provide health education, which is a low-cost, instant, and widely accessible method to support behavior change and improve health literacy, unlike traditional treatments that may rely on in-person visits or medications. ^{3 4 7 10 11}

Research Team

Megan McLaughlin, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for English-speaking adults over 40 years old who are living with HIV but do not have existing cardiovascular disease. Participants must own a smartphone and be willing to provide informed consent. Pregnant individuals cannot participate.

Inclusion Criteria

I am 40 years old or older.

You have HIV.

English-speaking

Exclusion Criteria

I have heart disease related to artery blockage.

Pregnant

Unwilling/unable to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive educational text messages about HIV and heart disease risk 3-5 times per week for up to 6 months

6 months

Monthly surveys via digital platform

Follow-up

Participants are monitored for cardiovascular risk factors and health outcomes after the intervention

4 weeks

Treatment Details

Interventions

• Digital Educational Messaging

Trial Overview The TEACH-HIV trial is testing whether educational text messages can help reduce the risk of heart disease in people with HIV. The effectiveness of these digital messages will be evaluated over time.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

The intervention arm will receive education about HIV and heart disease risk via mobile phone text messages for up to 6 months. They will receive the text messages 3-5 times per week. The messages will include information about HIV and risk of heart disease and information about how to reduce heart disease risk. The intervention arm will also receive brief monthly surveys via a digital research platform.

Group II: Control Arm Active Control 1 Intervention

The control arm will not receive the educational text messages. They will receive brief monthly surveys via a digital research platform.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A systematic review and meta-analysis of six randomized controlled trials involving 1,158 patients found that text message interventions had no significant effect on self-management outcomes for coronary heart disease, including self-efficacy and various health metrics like LDL and BMI.

The study concluded that using text messages as a method to improve treatment adherence and control risk factors in coronary heart disease patients does not provide any positive benefits compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Text Message On Self-Management for Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials. Wan, Y., Wu, X., Kou, Y.[2020]

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 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 cluster randomized trial involving 13,937 pregnant women in Hunan, China, tested a maternal education program delivered via text messaging, but the results showed no statistically significant differences in maternal and perinatal mortality rates between the intervention and control groups.

While the intervention arm had slightly lower rates of maternal (0.04% vs. 0.09%) and perinatal deaths (1.24% vs. 1.45%), the study suggests that larger trials with more intensive implementation are needed to confirm any potential benefits of SMS-based maternal education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Maternal Education Program Through Text Messaging in Rural China: Cluster Randomized Controlled Trial. Xie, RH., Tan, H., Taljaard, M., et al.[2020]

Adolescents responded positively to a weekly text message intervention that provided education on healthy behaviors and high-risk activities, indicating that this method effectively engages them in health education.

Participants reported learning new information and making behavioral changes, suggesting that long-term text message interventions can be an effective strategy for improving adolescent health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Educational Text Message Intervention on Adolescents' Knowledge and High-Risk Behaviors. Hickman, NE., Schaar, G.[2018]

Text messaging was successfully used to deliver essential healthcare lessons to over 2,500 South African midwives for 6 months, showing high acceptance and perceived improvement in learning and patient care.

Despite the positive reception, challenges such as limited internet access highlighted the need for further development in internet-based education, particularly in public healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messages as a learning tool for midwives. Woods, D., Attwell, A., Ross, K., et al.[2022]

A year-long SMS health education intervention significantly improved health literacy scores among community residents in China, with an increase from 61.8 to 63.3 points (P<0.01).

The intervention was particularly effective for males and local residents, showing a greater increase in health literacy compared to females and non-permanent residents, highlighting SMS as a cost-effective method for health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell phone-based health education messaging improves health literacy. Zhuang, R., Xiang, Y., Han, T., et al.[2018]

A formative assessment involving 42 parents and nutrition experts led to the creation of 16 tailored SMS messages aimed at supporting breastfeeding for expectant couples in Tigray, Ethiopia.

The intervention showed high engagement, with 87% of parents receiving multiple messages and nearly all fathers and 97% of mothers reading them, indicating strong interest in continued SMS support for infant feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-design and implementation of a mHealth intervention targeting fathers and mothers to improve breastfeeding. Gebremariam, KT., Mulugeta, A., Gallegos, D.[2023]

Text4baby is a pioneering free text messaging service in the U.S. designed to provide essential health information to pregnant women and new mothers, successfully enrolling over 320,000 participants from its launch in 2010 to March 2012.

The rapid enrollment and widespread promotion of Text4baby highlight the effectiveness of public-private partnerships in improving maternal and infant health through accessible communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4baby: development and implementation of a national text messaging health information service. Whittaker, R., Matoff-Stepp, S., Meehan, J., et al.[2021]

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]

References

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

The Impact of Text Message On Self-Management for Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials. [2020]

2. 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]

3. 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]

4. Canada pubmed.ncbi.nlm.nih.gov

The Impact of a Maternal Education Program Through Text Messaging in Rural China: Cluster Randomized Controlled Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Impact of an Educational Text Message Intervention on Adolescents' Knowledge and High-Risk Behaviors. [2018]

6. South Africa pubmed.ncbi.nlm.nih.gov

Text messages as a learning tool for midwives. [2022]

7. Uganda pubmed.ncbi.nlm.nih.gov

Cell phone-based health education messaging improves health literacy. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Co-design and implementation of a mHealth intervention targeting fathers and mothers to improve breastfeeding. [2023]

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

Text4baby: development and implementation of a national text messaging health information service. [2021]

10. 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]

11. 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]