NCT04578093

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

October 5, 2020

Last Update Submit

March 3, 2023

Conditions

Contraception Behavior

Keywords

teen pregnancy, adolescent contraception

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • LARC uptake

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

Will receive adjusts curriculum

Behavioral: LARC peer-based curriculum

Control

NO INTERVENTION

Will receive unadjusted curriculum

Interventions

LARC peer-based curriculumBEHAVIORAL

Peer-based educational videos and supplemental activities

Intervention

Eligibility Criteria

Age13 Years - 20 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly females can receive LARC
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • used LARC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Pooja R Patel, MD, MPH, MMS

    UTMB

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: case-control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 8, 2020

Study Start

January 1, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03