Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
Sponsor
Children's National Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04372485
Collaborator
(none)
270
2
59
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
270 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
Anticipated Study Start Date
:
Jul 1, 2022
Anticipated Primary Completion Date
:
Jun 1, 2027
Anticipated Study Completion Date
:
Jun 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: mHealth Adolescents enrolled in this arm will receive treatment-related text messages. |
Behavioral: mHealth Intervention
Adolescents will receive text messages to facilitate treatment adherence
|
| No Intervention: Usual care Adolescents in this arm will receive usual care. |
Outcome Measures
Primary Outcome Measures
- STI treatment adherence [1-21 days after prescription filling]
Proportion of study participants who complete their medication as prescribed by self-report
Secondary Outcome Measures
- STI treatment receipt [1-21 days after STI diagnosis]
Proportion of study participants who receive STI treatment; measured by prescription filling and/or receiving treatment at a healthcare facility
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's National Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Monika Goyal,
Associate Professor of Pediatrics and Emergency Medicine,
Children's National Research Institute
ClinicalTrials.gov Identifier:
NCT04372485
Other Study ID Numbers:
- Pro0001427
First Posted:
May 4, 2020
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: