Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

270 Participants Needed

mHealth for Sexually Transmitted Infections

Recruiting at 1 trial location

Overseen ByMeleah 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 GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether text messages can help people adhere to their treatment for sexually transmitted infections (STIs) more effectively than usual care, which excludes these messages. It focuses on common STIs like gonorrhea and chlamydia. Participants are divided into two groups: one receives treatment-related text messages (mHealth intervention), while the other receives usual care without messages. Suitable candidates for this trial have visited the Emergency Department, tested positive for specific STIs, and have a phone capable of receiving texts. As an unphased trial, this study allows participants to contribute to innovative research that could enhance STI treatment adherence for many.

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 prior data suggests that this mHealth intervention is safe for STI treatment adherence?

Research has shown that mobile health (mHealth) tools, such as treatment-related text messages, are generally safe and easy to use. Studies have found that these tools can enhance understanding of sexually transmitted infections (STIs) and facilitate access to testing services. No strong evidence indicates serious side effects or problems from using mHealth tools.

In large studies involving over 13,000 participants, digital health methods have successfully promoted safer sexual practices and improved sexual health. This suggests that using text messages in health programs does not pose significant risks. Given the similarity of the mHealth tool in this trial to those studied, it is expected to be equally safe.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about the mHealth intervention for sexually transmitted infections because it uses technology in a new way to support adolescent health. Unlike traditional treatments that often focus solely on medication or in-person consultations, this approach delivers treatment-related text messages. This digital method aims to improve adherence to care and provide timely information, making it more accessible and engaging for young people who are accustomed to using mobile devices. By integrating health management into everyday technology, it has the potential to enhance the effectiveness of existing care practices.

What evidence suggests that this mHealth intervention is effective for improving STI treatment adherence?

This trial will compare the effectiveness of an mHealth intervention with usual care. Studies have shown that mobile health (mHealth) tools can effectively improve the prevention of sexually transmitted infections (STIs) and encourage healthier behaviors. Research indicates that these tools can increase testing for HIV and other STIs and promote condom use. For example, one study found that a mobile-based educational program significantly improved health habits. Another study suggested that digital health tools might help prevent STIs and substance use problems. Overall, these findings suggest that mHealth tools could support adherence to STI treatments by providing accessible information and reminders through text messages.¹ ⁴ ⁶ ⁷ ⁸

Who Is on the Research Team?

Monika Goyal, MD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

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

See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: mHealthExperimental Treatment1 Intervention

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

Group II: Usual careActive Control1 Intervention

Adolescents in this arm will receive usual care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC8572487/

Mobile health interventions for HIV/STI prevention among ...Studies evaluating the effectiveness of mhealth interventions have also shown promising results such as increase in HIV testing, condom use, ...

2.researchprotocols.orgresearchprotocols.org/2024/1/e47216/

Efficacy of a Digital Health Preventive Intervention for ...This study has the potential to improve public health by preventing HIV/STI and substance use disorders.

3.bmcpublichealth.biomedcentral.combmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-18002-1

Efficacy of mobile-based educational intervention using ...The results of this study showed that a mobile-based educational intervention based on the ISD model had a significant effect on the preventive ...

4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37561571/

A Web-Based Sexual Health Intervention to Prevent ...This study aimed to evaluate the long-term cost-effectiveness of Smart Girlfriend in preventing STIs in the Chinese population.

5.mhealth.jmir.orgmhealth.jmir.org/2020/3/e16251/

Pilot Study of a Multilevel Mobile Health App for Substance ...Intervention Effects on Sexually Transmitted Infections/HIV Testing. We sought to determine whether STI/HIV testing behaviors varied by group ...

6.clinicaltrials.govclinicaltrials.gov/study/NCT04349748

MHealth Intervention of HIV and STDs Partner Notification ...Researchers expect that the HIV incidence will be significantly lower and the secondary outcomes will also be better after partner notification intervention. ...

7.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC9890991/

A systematic review of eHealth modes in preventing sexually ...We also extracted implementation outcomes and reviewed them. Included studies with 13,137 participants have provided reasonable evidence of the effectiveness of ...

8.onlinelibrary.wiley.comonlinelibrary.wiley.com/doi/full/10.1002/hsr2.70212

Efficacy of Digital Health Interventions Used for ...The findings of this research suggest that digital health interventions can be an effective way to promote safer sexual practices, improve sexual health ...

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mHealth for Sexually Transmitted Infections

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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