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Withdrawn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
-
-
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
|
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.
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
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.