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

March 3, 2023 updated by: The University of Texas Medical Branch, Galveston

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor Teen Health Clinics
        • Contact:
          • Pooja Patel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

used LARC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Will receive adjusts curriculum
Behavioral: LARC peer-based curriculum
Peer-based educational videos and supplemental activities
No Intervention: Control
Will receive unadjusted curriculum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Pooja R Patel, MD, MPH, MMS, UTMB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 8, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 20-0250

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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