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

NCT ID: NCT04372485

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mHealth

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

Group Type OTHER

mHealth Intervention

Intervention Type BEHAVIORAL

Adolescents will receive text messages to facilitate treatment adherence

Usual care

Adolescents in this arm will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mHealth Intervention

Adolescents will receive text messages to facilitate treatment adherence

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Monika Goyal

Associate Professor of Pediatrics and Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Goyal

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Meleah Boyle, MPH

Role: CONTACT

202-476-5388

Facility Contacts

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Monika Goyal

Role: primary

202-476-2869

Other Identifiers

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Pro0001427

Identifier Type: -

Identifier Source: org_study_id

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