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Contraception BehaviorNCT03400410

Hormonal Contraceptive Health Education for Adolescent Males

A study testing Education Arm in people with Contraception Behavior, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 21 years, men onlyHealthy volunteers can take part
Conditions the study is for
Contraception Behavior
What is being tested?
Education Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteUnited States
Study dates
21 May 2018to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 21 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington Univeristy at St Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Education Arm
Keywords
Contraception, Education, Male adolescents, Emergency Department, Unintended pregnancy
Medical subject headings
Contraception Behavior, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education ArmBehavioural

    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.

Study groups in NCT03400410
Study groupRoleWhat they receive
Education ArmExperimentalThis 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.
Receives: Behavioral: Education Arm
No Education ArmNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discussion rates

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

    Measured: 3 months

Secondary outcomes (3)

  1. Partner use of hormonal contraception

    Partner use of hormonal contraception as assessed by male adolescent.

    Measured: 3 months

  2. Fatherhood

    Rate of fatherhood of male adolescents in the study.

    Measured: Baseline (at initial contact) and 3 months

  3. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start21 May 2018
  3. Primary completion18 Mar 2020
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400410
Sponsor's protocol ID
201706139
Status last verified
Mar 2024
First submitted
9 Jan 2018
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • United Nations Population Fund. Adolescent Pregnancy: A Review of the Evidence. 2013; http://www.unfpa.org/publications/adolescent-pregnancy. Accessed Dec 2016, 2016.

  • Centers for Disease Control and Prevention. Reproductive Health: Teen Pregnancy. http://www.cdc.gov/teepregnancy/about/index.htm. Accessed Sept 2016.

  • 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.

    PubMed 23115878

  • 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.

    PubMed 9606224

  • 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.

    PubMed 28801483

Questions about this trial

What is this clinical trial studying?

A study testing Education Arm in people with Contraception Behavior, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discussion rates (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400410, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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