Hormonal Contraceptive Health Education for Adolescent Males

Not Applicable

Completed

• Conditions: Contraception Behavior
• Interventions: Behavioral: Education Arm

• Registration Number: NCT03400410
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.

Detailed Description

Unintended pregnancy among adolescents is a significant public health issue and U.S. adolescents have one of the highest unintended pregnancy rates among industrialized nations. An estimated 9% of male adolescents becoming fathers by the time they are 20 years old. Over 14 million adolescents use emergency departments every year and many of the adolescent males that present to the ED are engaged in high risk sexual behaviors which puts them at high risk for unintended pregnancy. This presents an opportunity to educate males that are at high risk about pregnancy prevention.

This study is a prospective randomized control trial of education about female hormonal contraception for these higher risk adolescent males, 15-21 years old, that present to the Saint Louis Children's Hospital pediatric emergency department. An electronic application will be used to take a sexual history and ask questions about patients' current attitudes and use of hormonal contraception with their partners. They will then be randomized to watch a video on female hormonal contraception (experimental group) or no video (control group). The video will be an overview with brief pros and cons of all available types of hormonal contraception. The app emphasizes importance of condom use as part of dual method protection throughout. All patients will be followed up in 3 months to complete a survey with similar questions on sexual history, discussions with partners, and current contraceptive practices. The hypothesis of the study is that this will lead to increased rates of discussion about hormonal contraception between male adolescents and their sexual partners. This may lead to increased contraceptive use rates and a decrease in unintended pregnancy.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Study Start: 2018-05-21
• Primary Completion: 2020-03-18
• Study Completion: 2022-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 107

Inclusion Criteria

• Male adolescents 15-21 years of age that are sexually active and have ever had vaginal sex that present to the St Louis Children's Hospital pediatric emergency department.

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Exclusion Criteria

• Males that have never had vaginal sex
• Require activation of the trauma system
• Triage as high severity (level 1 or level 2)
• Present for evaluation of abuse, sexual assault, or psychiatric issues
• Unable to speak English
• Wards of the state
• Disabilities that prevent independent use of a tablet device
• Have not completed the electronic adolescent health questionnaire that is standard of care in our emergency department as this is needed for screening purposes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Arm	Education Arm	This group will take a survey and be asked some sexual history questions including their contraceptive practices with their sexual partner(s). They will then watch the educational video on hormonal contraception and then be asked a few questions about the video. Then they will be asked for an email and phone number for follow up. They will then be followed up 3 months from their visit through their contact option of choice (email, text, or call) to take an additional survey with similar sexual history questions and current contraceptive practices including if they have discussed hormonal contraception with their female partners, if their female partners are now using hormonal contraception, and impregnation rates of female partners.

Primary Outcome Measures

Name	Time	Method
Discussion rates	3 months	Discussion rates of male adolescents with partner(s) about hormonal contraception.

Secondary Outcome Measures

Name	Time	Method
Fatherhood	Baseline (at initial contact) and 3 months	Rate of fatherhood of male adolescents in the study.
Male value of partner discussion and hormonal contraceptive knowledge	3 months	Yes or No question. Do they believe that partner discussion is important and do they believe that male knowledge of hormonal contraception is important.
Partner use of hormonal contraception	3 months	Partner use of hormonal contraception as assessed by male adolescent.

Trial Locations

Locations (1)

Washington Univeristy at St Louis; 🇺🇸 Saint Louis, Missouri, United States