Hormonal Contraceptive Health Education for Adolescent Males

NCT03400410 | Completed

• 1 other identifier: 201706139
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception Behavior

Keywords

Contraception; Education; Male adolescents; Emergency Department; Unintended pregnancy

Outcome Measures

Primary Outcomes (1)

• Discussion rates

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

  3 months

Secondary Outcomes (3)

• Partner use of hormonal contraception

  3 months

• Fatherhood

  Baseline (at initial contact) and 3 months

• Male value of partner discussion and hormonal contraceptive knowledge

  3 months

Study Arms (2)

Education Arm

EXPERIMENTAL

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

No Education Arm

NO INTERVENTION

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.

Interventions

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.

Education Arm

Eligibility Criteria

• Age: 15 Years - 21 Years
• Gender Eligibility Details: All those that are biologically male, no matter gender identity, that have ever had vaginal sex.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Univeristy at St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23115878 BACKGROUND

• 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.

  PMID: 9606224 BACKGROUND

• 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.

  PMID: 28801483 BACKGROUND

MeSH Terms

Conditions

Contraception Behavior; Emergencies

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fahd Ahmad, MD

  Washington Univeristy at St Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator assigned to follow up will be masked to which group a participant was assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: May 21, 2018
• Primary Completion: March 18, 2020
• Study Completion: December 30, 2022
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)