mHealth for Sexually Transmitted Infections

Overseen By Meleah Boyle, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must be taking: Antibiotics

Disqualifiers: Non-English, Critically ill, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

270 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.

What data supports the effectiveness of the mHealth Intervention treatment for sexually transmitted infections?

Research shows that mobile health (mHealth) interventions, like those using mobile phones, can improve sexual health outcomes by increasing STI testing and reducing risky behaviors, such as alcohol use, in young people. These interventions have been effective in promoting sexual health education and behavior change, which are crucial for preventing STIs. ^{1 2 3 4 5}

Is mHealth for sexually transmitted infections safe for humans?

The research on mHealth interventions for sexually transmitted infections primarily focuses on their effectiveness in improving sexual health knowledge and behavior. There is no specific mention of safety concerns, suggesting that these digital interventions are generally considered safe for human use. ^{3 6 7 8 9}

How is the mHealth Intervention treatment for sexually transmitted infections different from other treatments?

The mHealth Intervention is unique because it uses mobile phone technology to deliver educational content and promote safe sexual practices, making it more accessible and engaging, especially for young people. Unlike traditional treatments that focus on medication, this approach emphasizes prevention and behavior change through digital means. ^{1 2 3 6 10}

What is the purpose of this trial?

We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services.

Research Team

Monika Goyal, MD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

This trial is for adolescent patients who have tested positive for gonorrhea, chlamydia, or pelvic inflammatory disease in the Emergency Department and are prescribed outpatient antibiotics.

Inclusion Criteria

I am a teenager treated for an STD with antibiotics after an ER visit.

Exclusion Criteria

Patients will be excluded if they are unable to understand English

Patients will be excluded if they are critically ill

Patients will be excluded if they have cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STI treatment with adherence monitored through text messages or usual care

3 weeks

1 visit (in-person), ongoing text message interactions

Follow-up

Participants are monitored for STI treatment adherence and receipt after treatment

3 weeks

Treatment Details

Interventions

• mHealth Intervention

Trial Overview The study is testing if sending text messages to these patients can help them follow their STI treatment better compared to those who just get the usual care without texts.

Participant Groups

Group I: mHealth Experimental Treatment 1 Intervention

Adolescents enrolled in this arm will receive treatment-related text messages.

Group II: Usual care Active Control 1 Intervention

Adolescents in this arm will receive usual care.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Findings from Research

Mobile health (m-health) interventions have shown a positive impact on sexual health outcomes in adults with chronic diseases, based on a systematic review of nine studies published between 2009 and 2019.

Most interventions were delivered through websites and focused on therapy, self-help, and consultation, particularly for patients with prostate and breast cancer, indicating the need for user-centered design and integration with smartphone apps for enhanced effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health applications for improving the sexual health outcomes among adults with chronic diseases: A systematic review. Karim, H., Choobineh, H., Kheradbin, N., et al.[2022]

Mobile technology interventions, particularly SMS reminders, can significantly improve the uptake of sexual health services and STI testing, as shown in two of the ten randomized trials reviewed.

Despite some positive outcomes, no trials demonstrated a significant increase in condom use, highlighting the need for higher quality studies with standardized measures to better assess the impact of mobile interventions on safer sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies. Burns, K., Keating, P., Free, C.[2022]

Mobile phone-based interventions have the potential to be effective tools for preventing sexually transmitted infections (STIs) and HIV, as they can provide education and promote behavior change among users.

This systematic review will analyze randomized controlled trials to assess the effectiveness of these mobile interventions, ensuring a comprehensive evaluation of their impact on sexual health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of digital interventions based on mobile phones for the prevention of sexually transmitted infections: A systematic review protocol. Duarte, G., Vanegas, J., Bravo, G., et al.[2022]

A pilot study involving 367 adolescent girls (ages 15-19) revealed significant themes related to sexual health, including pressures from alcohol use and male peers, which contribute to risky sexual behaviors and STI acquisition.

The study supports the development of a culturally sensitive mobile health app aimed at educating and empowering adolescent girls about sexual health and STI prevention, based on their expressed needs and concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Love My Body: Pilot Study to Understand Reproductive Health Vulnerabilities in Adolescent Girls. Tzilos Wernette, G., Countryman, K., Khatibi, K., et al.[2020]

This systematic review aims to be the first comprehensive examination of how text messaging (SMS) can improve the prevention and management of sexually transmitted infections (STIs), addressing a significant gap in existing research.

By analyzing both quantitative and qualitative studies published since 1995, the review will provide evidence to support the integration of SMS interventions into standard STI care practices, potentially enhancing patient communication and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short message service (SMS) interventions for the prevention and treatment of sexually transmitted infections: a systematic review protocol. Lunny, C., Taylor, D., Memetovic, J., et al.[2021]

A mobile health app designed to promote safe sex and increase condom use among youth was developed based on direct input from 17 young participants (15 individual interviews and 2 focus groups) in Stockholm, emphasizing the importance of youth engagement in intervention design.

The app's content includes sex education, practical condom usage tips, and supportive messaging, with various delivery modes suggested by youth, such as text messages and videos, highlighting the need for engaging and relatable educational tools to effectively promote safe sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. Nielsen, A., Bågenholm, A., De Costa, A.[2020]

The Men's Safer Sex (MenSS) website is being tested in a pilot trial with 166 male participants aged 16 and over, aiming to assess its feasibility in increasing condom use and reducing sexually transmitted infections (STIs) among men who have had recent unprotected sex.

The primary outcome of the trial is to measure condom use at 3 months, while STI rates will be tracked through clinic records at 12 months, providing insights into the effectiveness of this digital intervention compared to usual sexual health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

A systematic review of 16 studies involving 13,137 participants found that eHealth interventions are effective in improving prevention strategies for sexually transmitted infections (STIs), particularly among young people.

Condom use was the most frequently assessed outcome in the studies, highlighting its importance in STI prevention efforts facilitated by eHealth platforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of eHealth modes in preventing sexually transmitted infections. Nourimand, F., Keramat, A., Sayahi, M., et al.[2023]

The HEART digital sexual health intervention was successfully redeveloped to be more interactive and accessible, allowing for broader dissemination and customization, which is crucial for addressing HIV/STDs and unintended pregnancies among adolescents.

In a study involving 233 adolescents, the new HEART program was found to be highly acceptable and feasible, showing no differences in acceptability based on gender or sexual identity, indicating its potential for widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redeveloping a Digital Sexual Health Intervention for Adolescents to Allow for Broader Dissemination: Implications for HIV and STD Prevention. Javidi, H., Widman, L., Lipsey, N., et al.[2021]

A systematic review of 11 studies on mHealth interventions for HIV/STI prevention in young people (ages 10-24) in low- and middle-income countries found that these interventions are highly acceptable and appropriate, with feasibility being evaluated in 83% of the studies.

However, there is a significant lack of data on important implementation outcomes such as adoption, cost, penetration, and sustainability, indicating a need for further research to understand the long-term effectiveness and viability of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health interventions for HIV/STI prevention among youth in low- and middle-income countries (LMICs): a systematic review of studies reporting implementation outcomes. Nwaozuru, U., Obiezu-Umeh, C., Shato, T., et al.[2021]

References

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

Mobile health applications for improving the sexual health outcomes among adults with chronic diseases: A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies. [2022]

3. Chile pubmed.ncbi.nlm.nih.gov

Effectiveness of digital interventions based on mobile phones for the prevention of sexually transmitted infections: A systematic review protocol. [2022]

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

Love My Body: Pilot Study to Understand Reproductive Health Vulnerabilities in Adolescent Girls. [2020]

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

Short message service (SMS) interventions for the prevention and treatment of sexually transmitted infections: a systematic review protocol. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. [2022]

8. India pubmed.ncbi.nlm.nih.gov

A systematic review of eHealth modes in preventing sexually transmitted infections. [2023]

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

Redeveloping a Digital Sexual Health Intervention for Adolescents to Allow for Broader Dissemination: Implications for HIV and STD Prevention. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Mobile health interventions for HIV/STI prevention among youth in low- and middle-income countries (LMICs): a systematic review of studies reporting implementation outcomes. [2021]