Using Mobile Health (mHealth) to Improve STI Treatment Ad... | NCT04372485

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

NCT04372485

Sponsor

Children's National Research Institute

Status

Recruiting

Last Update Posted

Aug 21, 2024Actual

Enrollment

270Estimated

Phase

Not Applicable

Conditions

Sexually Transmitted Diseases

Interventions

mHealth Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2024Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Monika Goyal, Associate Professor of Pediatrics and Emergency Medicine, Children's National Research InstitutePrincipal Investigator

Lead Sponsor

Children's National Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
mHealth Intervention	Behavioral	Adolescents will receive text messages to facilitate treatment adherence	mHealth

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STI treatment adherence	Proportion of study participants who complete their medication as prescribed by self-report	1-21 days after prescription filling

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meleah Boyle, MPH	Contact	202-476-5388		mdboyle@childrensnational.org

Overall Officials

Name	Affiliation	Role
Monika Goyal	Children's National Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Hospital	Recruiting	Washington D.C.	District of Columbia	20016-1838	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012749	Sexually Transmitted Diseases

Ancestor Terms

ID	Term
D003141	Communicable Diseases
D007239	Infections
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided