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NCT04372485 Clinical Trial

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

Sexually Transmitted Diseases Clinical Trial

Official title:
Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04372485
Other study ID # Pro0001427
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date June 2027

Study information
Verified date August 2023
Source Children's National Research Institute
Contact Meleah Boyle, MPH
Phone 202-476-5388
Email mdboyle@childrensnational.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 270
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 15 Years to 21 Years
Eligibility 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: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• mHealth Intervention
Adolescents will receive text messages to facilitate treatment adherence

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Children's National Research Institute

Outcome
Type Measure Description Time frame Safety issue
Primary STI treatment adherence Proportion of study participants who complete their medication as prescribed by self-report 1-21 days after prescription filling
Secondary STI treatment receipt Proportion of study participants who receive STI treatment; measured by prescription filling and/or receiving treatment at a healthcare facility 1-21 days after STI diagnosis
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