Clinical trial NCT03400410: Hormonal Contraceptive Health Education for Adolescent Males
Official title: Hormonal Contraceptive Health Education for Adolescent Males in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: Contraception
Education
Male adolescents
Emergency Department
Unintended pregnancy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 107
Sex: MALE
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discussion rates
timeFrame: 3 months
Secondary outcomes:
measure: Partner use of hormonal contraception
timeFrame: 3 months
measure: Fatherhood
timeFrame: Baseline (at initial contact) and 3 months
measure: Male value of partner discussion and hormonal contraceptive knowledge
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington Univeristy at St Louis
state: Missouri
Study officials:
affiliation: Washington Univeristy at St Louis
name: Fahd Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: United Nations Population Fund. Adolescent Pregnancy: A Review of the Evidence. 2013; http://www.unfpa.org/publications/adolescent-pregnancy. Accessed Dec 2016, 2016.
citation: Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.
citation: Mosher WD, Jones J, Abma JC. Intended and unintended births in the United States: 1982-2010. Natl Health Stat Report. 2012 Jul 24;(55):1-28.
citation: Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States. Pediatrics. 1998 Jun;101(6):987-94. doi: 10.1542/peds.101.6.987.
citation: Ahmad FA, Jeffe DB, Plax K, Schechtman KB, Doerhoff DE, Garbutt JM, Jaffe DM. Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department. Emerg Med J. 2018 Jan;35(1):46-51. doi: 10.1136/emermed-2016-206199. Epub 2017 Aug 11.