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

Primary Purpose

Sexually Transmitted Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mHealth Intervention
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexually Transmitted Diseases

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    mHealth

    Usual care

    Arm Description

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

    Adolescents in this arm will receive usual care.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 30, 2020
    Last Updated
    August 28, 2023
    Sponsor
    Children's National Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04372485
    Brief Title
    Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
    Official Title
    Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    June 2027 (Anticipated)
    Study Completion Date
    June 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's National Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexually Transmitted Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    270 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mHealth
    Arm Type
    Other
    Arm Description
    Adolescents enrolled in this arm will receive treatment-related text messages.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Adolescents in this arm will receive usual care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    mHealth Intervention
    Intervention Description
    Adolescents will receive text messages to facilitate treatment adherence
    Primary Outcome Measure Information:
    Title
    STI treatment adherence
    Description
    Proportion of study participants who complete their medication as prescribed by self-report
    Time Frame
    1-21 days after prescription filling
    Secondary Outcome Measure Information:
    Title
    STI treatment receipt
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meleah Boyle, MPH
    Phone
    202-476-5388
    Email
    mdboyle@childrensnational.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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