An interventional study of Education Arm in Contraception Behavior, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to male participants aged 15 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.
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.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's enrollment of 107 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Education Arm
This group will take a survey and be asked some sexual history questions including contraceptive practices with their sexual partner(s). They will then 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.
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.
Discussion rates
Discussion rates of male adolescents with partner(s) about hormonal contraception.
Time frame: 3 months
Partner use of hormonal contraception
Partner use of hormonal contraception as assessed by male adolescent.
Time frame: 3 months
Fatherhood
Rate of fatherhood of male adolescents in the study.
Time frame: Baseline (at initial contact) and 3 months
Male value of partner discussion and hormonal contraceptive knowledge
Yes or No question. Do they believe that partner discussion is important and do they believe that male knowledge of hormonal contraception is important.
Time frame: 3 months
Plan to share: No
Ran from May 2018 to primary completion in Mar 2020, 21 months.
Of 64 non-industry interventional studies with no phase under Contraception Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 21 months is close to that.
Counting every sponsor, half of 64 studies reached it within 20 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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