Implementation Strategy for a Peer-based Intervention to... | NCT04578093

Studies
Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy

NCT04578093

Sponsor

The University of Texas Medical Branch, Galveston

Status

Withdrawn

Last Update Posted

Mar 7, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Contraception Behavior

Interventions

LARC peer-based curriculum

Countries

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI No Longer at Institution

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 8, 2022Actual

Completion Date

Jun 8, 2022Actual

First Submitted Date

Oct 5, 2020

First Submission Date that Met QC Criteria

Oct 5, 2020

First Posted Date

Oct 8, 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

Mar 3, 2023

Last Update Posted Date

Mar 7, 2023Actual

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

Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Will receive adjusts curriculum	Behavioral: LARC peer-based curriculum
Control	No Intervention	Will receive unadjusted curriculum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LARC peer-based curriculum	Behavioral	Peer-based educational videos and supplemental activities	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inquiries made of provider	Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider.	6 months

Secondary Outcomes

Measure	Description	Time Frame
LARC uptake	Incidence of teenager using IUD or subnormal implant.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female, never used LARC, attending high school, less than 20 yo

Exclusion Criteria:

used LARC

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only females can receive LARC

Minimum Age

13 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pooja R Patel, MD, MPH, MMS	UTMB	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003268	Contraception Behavior

Ancestor Terms

ID	Term
D043762	Reproductive Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided