Reducing Teen Pregnancy in the Emergency Department

Not Applicable

Completed

• Conditions: Reproductive Behavior; Adolescent Behavior; Contraception; Sexual Behavior
• Interventions: Behavioral: Dr. Erica

• Registration Number: NCT03866811
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-08
• Study Start: 2019-03-03
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Results First Submitted: 2023-10-02
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Results First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

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

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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"

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Dr. Erica	The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week).

Primary Outcome Measures

Name	Time	Method
Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)]	3 months	Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following: * intrauterine device; * birth control implant; * birth control patch; * birth control pills or oral contraceptives; * injectable birth control; * a vaginal ring

Secondary Outcome Measures

Name	Time	Method
Feasibility: Percentage of Refusal	Baseline	Percentage of eligible participants who refused
Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey	3 months	Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends
Any Sex Over the Past 3 Months	1 year	Self-report of any over the past 3 months.
Feasibility: Opt Outs Measured Via Mobile Platform	3 months	Percentage of enrolled participants in the intervention group who texted to stop receiving messages.
Number of Enrolled Participants Who do Not Complete Follow up	3 months	Measurement of the feasibility of Dr. Erica among adolescent female users

Trial Locations

Locations (1)

Morgan Stanley Children's Hospital Emergency Department; 🇺🇸 New York, New York, United States