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Reducing Teen Pregnancy in the Emergency Department (ERICA)

Primary Purpose

Reproductive Behavior, Sexual Behavior, Adolescent Behavior

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dr. Erica
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reproductive Behavior focused on measuring emergency medicine, reproductive health, sexual health, adolescent health, emergency department, text messaging, mobile health, digital health

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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"

Sites / Locations

  • Morgan Stanley Children's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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).

Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.

Outcomes

Primary Outcome Measures

Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
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
Potential Efficacy: Contraceptive at Last Intercourse Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Rates of contraceptive use at last intercourse will be reported by participants via telephone or online survey. Condom use will be included.

Secondary Outcome Measures

Feasibility: Percentage of refusal [Baseline at enrollment]
Percentage of eligible participants who refused enrollment
Feasibility: Opt outs measured via mobile platform [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Percentage of enrolled participants in the intervention group who texted to stop receiving messages
Feasibility: Loss to follow up measured via online or telephone survey [Close of intervention at 12 weeks]
Percentage of enrolled participants who do not complete follow up via either telephone or online survey
Feasibility/Acceptability: Interaction with text messages measured via mobile platform provider [[Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Percentage of participants in the intervention group who replied to each interactive text message
Acceptability: Satisfaction with the intervention measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Percentage of participants in the intervention group who answer that they like the program and would recommend it to friends

Full Information

First Posted
February 8, 2019
Last Updated
October 26, 2020
Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03866811
Brief Title
Reducing Teen Pregnancy in the Emergency Department
Acronym
ERICA
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reproductive Behavior, Sexual Behavior, Adolescent Behavior, Contraception
Keywords
emergency medicine, reproductive health, sexual health, adolescent health, emergency department, text messaging, mobile health, digital health

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial with two arms
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to study enrollment arm.
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED.
Intervention Type
Behavioral
Intervention Name(s)
Dr. Erica
Intervention Description
The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
Primary Outcome Measure Information:
Title
Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
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
Time Frame
3 months
Title
Potential Efficacy: Contraceptive at Last Intercourse Rates [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Rates of contraceptive use at last intercourse will be reported by participants via telephone or online survey. Condom use will be included.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Feasibility: Percentage of refusal [Baseline at enrollment]
Description
Percentage of eligible participants who refused enrollment
Time Frame
Baseline
Title
Feasibility: Opt outs measured via mobile platform [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Percentage of enrolled participants in the intervention group who texted to stop receiving messages
Time Frame
3 months
Title
Feasibility: Loss to follow up measured via online or telephone survey [Close of intervention at 12 weeks]
Description
Percentage of enrolled participants who do not complete follow up via either telephone or online survey
Time Frame
3 months
Title
Feasibility/Acceptability: Interaction with text messages measured via mobile platform provider [[Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Percentage of participants in the intervention group who replied to each interactive text message
Time Frame
3 months
Title
Acceptability: Satisfaction with the intervention measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Percentage of participants in the intervention group who answer that they like the program and would recommend it to friends
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Exploratory Efficacy Outcome: Change in Preventive Reproductive Care Follow up measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Difference in percentages of those who follow up to preventive reproductive care in the intervention versus the control group based on telephone or online survey results
Time Frame
3 months
Title
Exploratory Efficacy Outcome: Change in Contraception Self-Efficacy measured via online or telephone survey [Time Frame: Enrollment, 12 weeks post-enrollment (2 weeks post close of intervention)]
Description
Difference in contraception self-efficacy between those in the intervention and control groups based on data collected on the telephone or online follow up survey
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female adolescent emergency department patients
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Chernick, MD MSc
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morgan Stanley Children's Hospital Emergency Department
City
Manhattan
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Teen Pregnancy in the Emergency Department

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