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RecruitingNCT04372485Updated Oct 22, 2026

Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents

An interventional study of mHealth Intervention in Sexually Transmitted Diseases, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 15 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Children's National Research Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
15 Years to 21 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sexually Transmitted Diseases
03

In context

Sexually Transmitted Diseases

435 studies on the registry are indexed under Sexually Transmitted Diseases; 73 are open to participants now.

This study's planned enrollment of 270 is below the median of 460 across 356 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescent patients seen in the Emergency Department who test positive for gonorrhea, chlamydia, or pelvic inflammatory disease and are prescribed outpatient antibiotic treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded if they are unable to understand English, are critically ill, have cognitive impairment or if they do not have access to a cellular telephone with text messaging capabilities.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Other
    mHealth

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

    Behavioral: mHealth Intervention

  • No intervention
    Usual care

    Adolescents in this arm will receive usual care.

Interventions

  • BehavioralmHealth Intervention

    Adolescents will receive text messages to facilitate treatment adherence

06

What researchers measure

Primary outcomes

  1. STI treatment adherence

    Proportion of study participants who complete their medication as prescribed by self-report

    Time frame: 1-21 days after prescription filling

Secondary outcomes

  1. STI treatment receipt

    Proportion of study participants who receive STI treatment; measured by prescription filling and/or receiving treatment at a healthcare facility

    Time frame: 1-21 days after STI diagnosis

07

Study locations

1 of 1 sites recruiting
  • Children's National Hospital
    Washington D.C., District of Columbia 20016-1838, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and contact details
1 update, last Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Minor edits only
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04372485
Responsible party
Monika Goyal (Associate Professor of Pediatrics and Emergency Medicine, Children's National Research Institute) — Principal investigator
First posted
May 4, 2020
Start date
Jun 3, 2024
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Meleah Boyle, MPH
Contact
mdboyle@childrensnational.org
202-476-5388
Monika Goyal
principal investigator · Children's National Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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