Adolescent Behavior, Contraception, Reproductive Behavior, Sexual Behavior
Conditions
Keywords
emergency medicine, reproductive health, sexual health, adolescent health, emergency department, text messaging, mobile health, digital health
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.
Interventions
BEHAVIORALDr. Erica
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to study enrollment arm.
Intervention model description
A randomized controlled trial with two arms
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percentage of Refusal | Baseline | Percentage of eligible participants who refused |
| Feasibility: Opt Outs Measured Via Mobile Platform | 3 months | Percentage of enrolled participants in the intervention group who texted to stop receiving messages. |
| 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. |
| Number of Enrolled Participants Who do Not Complete Follow up | 3 months | Measurement of the feasibility of Dr. Erica among adolescent female users |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care | 3 months | Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered yes to the question: Over the past 3 months, have you seen a doctor for medical care? In this Outcome, preventative reproductive care is defined as any visit to a doctor for the purposes of reproductive health. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Dr. Erica consists of two parts-a digital ED-based brief intervention and multimedia text messaging. | 72 |
| Control Arm Those randomized to usual care received an introductory text message to ensure texting capabilities for follow-up. No other edu- cation was provided outside usual care in the ED. | 74 |
| Total | 146 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Customized 14-17 years old | 29 Participants | 25 Participants | 54 Participants |
| Age, Customized 18-19 years old | 43 Participants | 49 Participants | 92 Participants |
| Race/Ethnicity, Customized African American | 20 Participants | 14 Participants | 34 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native American or Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 39 Participants | 40 Participants | 79 Participants |
| Race/Ethnicity, Customized Unknown (data not collected) | 9 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 72 Participants | 74 Participants | 146 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 74 |
| other Total, other adverse events | 0 / 72 | 0 / 74 |
| serious Total, serious adverse events | 0 / 72 | 0 / 74 |
Outcome results
Primary
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
Time frame: 3 months
Population: Only participants who provided self-report updates at the 3 months follow up mark were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)] | 14 Participants |
| Control Arm | Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)] | 14 Participants |
Secondary
Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey
Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends
Time frame: 3 months
Population: Includes all participants in the intervention arm who completed the required follow up post-intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey | 48 Participants |
Secondary
Any Sex Over the Past 3 Months
Self-report of any over the past 3 months.
Time frame: 1 year
Population: Includes participants in each arm who completed the follow-up post-intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Any Sex Over the Past 3 Months | 39 Participants |
| Control Arm | Any Sex Over the Past 3 Months | 49 Participants |
Secondary
Feasibility: Opt Outs Measured Via Mobile Platform
Percentage of enrolled participants in the intervention group who texted to stop receiving messages.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Feasibility: Opt Outs Measured Via Mobile Platform | 5 Participants |
Secondary
Feasibility: Percentage of Refusal
Percentage of eligible participants who refused
Time frame: Baseline
Population: Includes those who were eligible for enrollment who were screened for study participation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Feasibility: Percentage of Refusal | 27 Participants |
Secondary
Number of Enrolled Participants Who do Not Complete Follow up
Measurement of the feasibility of Dr. Erica among adolescent female users
Time frame: 3 months
Population: Includes the total number of participants randomized to each arm, regardless of follow up completion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Enrolled Participants Who do Not Complete Follow up | 15 Participants |
| Control Arm | Number of Enrolled Participants Who do Not Complete Follow up | 10 Participants |
Other Pre-specified
Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care
Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered yes to the question: Over the past 3 months, have you seen a doctor for medical care? In this Outcome, preventative reproductive care is defined as any visit to a doctor for the purposes of reproductive health.
Time frame: 3 months
Population: This population answered yes or no the question prompted by Dr. Erica: Over the past 3 months, have you been to the Columbia Family Planning Clinic?
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care | 35 Participants |
| Control Arm | Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care | 42 Participants |