Hormonal Contraceptive Health Education for Adolescent Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Providing Adolescent Contraception in the Emergency Room

NCT02475980

Contraception

COMPLETED

Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study

NCT05194202

Adolescent Behavior Emergency Department Abuse Physical +5 more

COMPLETED NA

A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department

NCT02093884

Pregnancy

COMPLETED NA

Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)

NCT01432041

Injury Prevention

COMPLETED NA

Outcomes in Youth Visiting the ED With Mental Health Issues: a Pilot Text Based Intervention

NCT02744326

Mental Health Disorder Mental and Behavioral Disorder Self-inflicted Injury

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

The investigator assigned to follow up will be masked to which group a participant was assigned to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Education Arm

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes