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Completed

NCT Number: NCT03400410

Hormonal Contraceptive Health Education for Adolescent Males

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

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Key information

Age range

15 year–21 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington Univeristy at St Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Education Arm

Behavioral

The educational video will be an overview with brief pros and cons of all types of available hormonal contraception. There will be emphasis on the importance of condom use as part of dual method protection.

Primary outcomes

  1. Discussion rates

    Time frame: 3 months

    Discussion rates of male adolescents with partner(s) about hormonal contraception.

Secondary outcomes

  1. Partner use of hormonal contraception

    Time frame: 3 months

    Partner use of hormonal contraception as assessed by male adolescent.

  2. Fatherhood

    Time frame: Baseline (at initial contact) and 3 months

    Rate of fatherhood of male adolescents in the study.

  3. Male value of partner discussion and hormonal contraceptive knowledge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Hormonal Contraceptive Health Education for Adolescent Males in the Pediatric Emergency Department

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jan 17, 2018
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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