Clinical trial NCT03866811: Reducing Teen Pregnancy in the Emergency Department
Official title: Targeting High Risk Teens in the Emergency Department: A User-Informed, Theory-Based Intervention Using Text Messaging to Reduce Teen Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Behavior
Sexual Behavior
Adolescent Behavior
Contraception
Keywords: emergency medicine
reproductive health
sexual health
adolescent health
emergency department
text messaging
mobile health
digital health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-03-07
Enrollment: 146
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with two arms
Primary purpose: PREVENTION

Brief summary: This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.

Detailed description: Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population.

In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone.

At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.

Eligibility criteria: Inclusion Criteria:

* female emergency department patient
* age 14-19 years
* sexually active with males in the past 3 months

Exclusion Criteria:

* currently using any effective form of contraception
* do not own a mobile phone with texting
* are pregnant
* are too ill for participation per the attending physician
* are cognitively impaired
* do not live locally
* do not speak English
* want to "become pregnant in the next year"

Primary outcomes:
measure: Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]
timeFrame: 3 months
Secondary outcomes:
measure: Feasibility: Percentage of Refusal
timeFrame: Baseline
measure: Feasibility: Opt Outs Measured Via Mobile Platform
timeFrame: 3 months
measure: Number of Enrolled Participants Who do Not Complete Follow up
timeFrame: 3 months
measure: Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey
timeFrame: 3 months
measure: Any Sex Over the Past 3 Months
timeFrame: 1 year
Other outcomes:
measure: Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care
timeFrame: 3 months
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital Emergency Department
state: New York
Study officials:
affiliation: Columbia University
name: Lauren S. Chernick, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: