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Hormonal Contraceptive Health Education for Adolescent Males

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ClinicalTrials.gov Identifier: NCT03400410
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Behavioral: Education Arm Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The investigator assigned to follow up will be masked to which group a participant was assigned to.
Primary Purpose: Prevention
Official Title: Hormonal Contraceptive Health Education for Adolescent Males in the Pediatric Emergency Department
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: 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.

Behavioral: Education Arm
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.

No Intervention: No 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.




Primary Outcome Measures :
  1. Discussion rates [ Time Frame: 3 months ]
    Discussion rates of male adolescents with partner(s) about hormonal contraception.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All those that are biologically male, no matter gender identity, that have ever had vaginal sex.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400410


Contacts
Contact: Kayleigh Fischer, MD 314-454-2341 k.fischer@wustl.edu
Contact: Fahd Ahmad, MD 314-454-2341 fahd.ahmad@wustl.edu

Locations
United States, Missouri
Washington Univeristy at St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kayleigh Fischer, MD    314-454-2341    k.fischer@wustl.edu   
Contact: Fahd Ahmad, MD    314-454-2341    fahd.ahmad@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kayleigh Fischer, MD Washington Univeristy at St Louis

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03400410     History of Changes
Other Study ID Numbers: 201706139
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Contraception
Education
Male adolescents
Emergency Department
Unintended pregnancy

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs