Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04578093
Collaborator
(none)
300
1
2
36
8.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
case-controlcase-control
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Actual Study Start Date
:
Jan 1, 2021
Anticipated Primary Completion Date
:
Jan 1, 2024
Anticipated Study Completion Date
:
Jan 1, 2024
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Inquiries made of provider [6 months]
Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider.
Secondary Outcome Measures
- LARC uptake [3 years]
Incidence of teenager using IUD or subnormal implant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
to 20 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
female, never used LARC, attending high school, less than 20 yo
Exclusion Criteria:
used LARC
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Teen Health Clinics | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Medical Branch, Galveston
Investigators
- Principal Investigator: Pooja R Patel, MD, MPH, MMS, UTMB
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT04578093
Other Study ID Numbers:
- IRB 20-0250
First Posted:
Oct 8, 2020
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Texas Medical Branch, Galveston