NCT04372485

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jun 2024Jun 2027

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
4.1 years until next milestone

Study Start

First participant enrolled

June 3, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

April 30, 2020

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • STI treatment adherence

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

    1-21 days after prescription filling

Secondary Outcomes (1)

  • STI treatment receipt

    1-21 days after STI diagnosis

Study Arms (2)

mHealth

OTHER

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

Behavioral: mHealth Intervention

Usual care

NO INTERVENTION

Adolescents in this arm will receive usual care.

Interventions

Adolescents will receive text messages to facilitate treatment adherence

mHealth

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20016-1838, United States

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Monika Goyal

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

June 3, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations