A Trial of an Adolescent Male Sexual Health Intervention (DrEric)

A Digital Intervention to Improve the Sexual and Reproductive Health of Male Adolescent Emergency Department Patients

Early unintended fatherhood and rates of sexually transmitted infections remain national concerns, disproportionately affecting minority, underserved adolescent males, many of whom frequently use emergency departments (EDs) for medical care. EDs must implement effective sexual and reproductive health interventions that are evidence-based and reproducible. This research will conduct pilot testing of a personalized and interactive digital intervention specifically targeting adolescent males entitled Dr. Eric that is theory-based, user-informed, and scalable across EDs.

Study Overview

• Status: Completed
• Conditions: Contraception Behavior
• Intervention / Treatment: Behavioral: Dr. Eric Digital Health Intervention

Detailed Description

Emergency Departments (EDs) care for 19 million adolescents each year, the majority of whom are low-income, racial and ethnic minorities, and participating in risky sexual behaviors. Despite a growing interest in expanding the role of the ED to provide preventive care, ED providers identify limited resources and time constraints as barriers to the implementation of public health interventions. Novel interventions are needed that fit efficiently within the ED workflow. The prior work of these investigators highlighted a significant public health problem-high risk sex among the adolescent male ED population. The investigators demonstrated that adolescent male ED patients are frequently having sex without condoms, increasing their risk of unintended early fatherhood and sexually transmitted infections (STI). These adolescents admit to low knowledge of effective contraceptive methods and having few discussions with medical providers and sexual partners about these methods. However, these male adolescents are receptive to sexual and reproductive health (SRH) interventions, particularly during the ED visit and via digital technology. They are particularly interested in interventions that feel relatable and are from a trustworthy source. To date, no intervention has successfully increased contraceptive use among this high risk, hard-to-reach ED population. Additionally, although evidence suggests that SRH digital interventions can improve SRH health, few interventions specifically target males. To improve adolescent SRH outcomes, the investigators have gathered an accomplished team with expertise in adolescent health, ED-based clinical trials, mobile health, and user-informed digital interventions. They created a novel intervention of an ED-based, theory-based, user-informed SRH digital intervention that includes a tailored educational app and 3 months of personalized and interactive text messaging. In this study, the investigators will conduct a pilot randomized controlled trial of Dr. Eric (Emergency Room Interventions to improve Care) to assess implementation outcomes and potential effectiveness. The investigators hypothesize that the Dr. Eric intervention will be feasible in the ED setting, be acceptable to adolescent males, demonstrate fidelity, and be adopted by users. The investigators also hypothesize that sexually active adolescent male ED patients who receive Dr. Eric will more often have consistent condom use than those who receive standard outpatient referral alone. These data will inform a subsequent multi-center clinical trial with sufficient power to measure clinically significant changes in consistent condom use. Ultimately, a digital ED-based intervention that is effective and automated can be utilized by other EDs as a reproducible and scalable means to promote sexual and reproductive preventive care, decrease unintended early fatherhood and STI risk among adolescent males, and improve adolescent health outcomes throughout the United States.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10528
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ED male adolescent patients aged 14-21 years
• sexually active (vaginal intercourse) with females in the past 3 months

Exclusion Criteria:

• do not own a mobile phone
• too ill per the attending
• are cognitively impaired
• does not speak English
• want their partner to become pregnant in the next year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dr. Eric Digital Health Intervention; Participants will interact with an ED-based iPad and the Dr. Eric app for a recorded period of time. After completion, an animated video will explain the ERIC texting program and "live" office hours. The participant enters his phone number and then receives a welcome text. Weekly texts are sent directly to the participant phone via short message service (SMS).	Behavioral: Dr. Eric Digital Health Intervention; Dr. Eric is a user-informed, theory-based, digital health intervention that aims to improve adolescent male SRH. This ED-based intervention consists of two parts-an interactive, tailored app and 3 months of personalized, two-way text messaging. It is based on an evidence-based sexual health curriculum we developed using established behavioral theories, prior literature, input from key stakeholders, qualitative patient interviews, and our prior ED-based work.
No Intervention: Standard of Care; Participants randomized to the SC arm will receive standard medical care as determined by the ED provider, which is typically referral to a primary care or adolescent provider. Mobile telephone numbers will be collected for follow up purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eligible Participants Who Agreed to be Enrolled in the Study	Implementation, feasibility: This outcome is designed to measure feasibility - the extent to which an innovation can be used in a setting. The investigators will measure the number of participants who are eligible, and agree to be enrolled into the study.	From day 1 of enrollment until the final day of enrollment (1 year)
Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)	Implementation, acceptability: This outcome is to measure acceptability for the intervention group only. Acceptability is the extent to which the innovation is agreeable to a stakeholder. The investigators asked the Agree/Disagree question of "Dr. Eric meets my approval," as self-reported after app completion.	From day 1 of enrollment until the final day of enrollment (1 year)
The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)	Implementation, adoption: This outcome is for the intervention group only. Th investigators assessed adoption by measuring the number of intervention participants who interacted with all 5 educational modules, based off of data that is recorded by the app.	From day 1 of enrollment until the final day of enrollment (1 year)
Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY)	Implementation, fidelity: This outcome is for the intervention group only. Fidelity is the extent to which an intervention is used as intended. This outcome measures the number of participants in the intervention group who opt out of the texting messaging component of the program.	3 months
Percentage of Condom Use Among Participants	Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome and only includes participants who completed follow-up at 13 weeks. Percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentage of condom use within each arm.	3 months (or 13 weeks)
Percentage of Condom Use Among Participants	Efficacy, Consistent Condom Use: This outcome is designed to measure efficacy and is a self-reported outcome. This outcome only includes participants who completed follow-up at 6 weeks and were sexually active in the prior 4 weeks. The percentages are calculated by dividing the total number of episodes of vaginal intercourse by the total number of times a male condom was used during vaginal intercourse over the past 4 weeks to report percentages of condom use within each arm.	6 weeks
Number of Participants That Are Lost to Follow up (at Each Time Point)	Implementation, feasibility: This outcome is to measure feasibility for both arms in which feasibility is defined as the extent to which an innovation can be used in a setting. The investigators will measure the number of participants in each arm that are lost to follow up in each respective arm at the 6 and 13 week time point. Lost to follow up means that we tried to contact the participant to assess outcome measures but they did not respond to texts or phone calls.	6 and 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Had Intercourse Over the Past 4 Weeks	Efficacy, Abstinent: This outcome is self-reported where participants are asked if they had penile-vaginal intercourse over the past 4 week. The binary outcome is measured from a "Yes" or "No" response.	3 month (13 weeks)
Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months	Efficacy, Talked to a partner about ways to prevent pregnancy over the past 3 months: This outcome is based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.	3 month (13 weeks)
Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months	Efficacy, Tested for a sexually transmitted infection over the past 3 months: This outcome is based on self-reported responses on the follow-up survey, in which the binary outcome is measured from a "Yes" or "No" response.	3 month (13 weeks)
Number of Participants Who Tested for HIV Over the Past 3 Months	Efficacy, Tested for HIV over the past 3 months: This outcome was based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.	3 month (13 weeks)
Number of Participants Who Consistently Used Condoms at Every Intercourse	Efficacy, Consistent Condom Use at Every Intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks. Answere are binary (yes/no) to using a condom at every intercourse over the past 3 months.	3 months (or 13 weeks)
Number of Participants Who Used a Condom at Last Intercourse	Efficacy, Use a condom at last intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks and were sexually active. Answers are binary (yes/no) to the question if a condom was used at last intercourse.	3 months (or 13 weeks)
Number of Participants Who Used Any Contraceptive Method at Last Intercourse	Efficacy, Used any method of contraception at last intercourse: This outcome is based on self-reported responses on the follow-up survey in which the binary outcome is measured from a "Yes" or "No" response.	3 month (13 weeks)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Lauren Chernick, MD MSc, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Mobile health; Digital health; Sexual health; Adolescent health; Sexual education
• Other Study ID Numbers: AAAT6680; R21NR019181 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final dataset will include self-reported demographic and behavioral data from baseline questionnaires, telephone follow up, and text message data collection. It will also contain usability testing information. All participants will be assigned a unique identifier and all data will remain confidential.
• IPD Sharing Time Frame: Data will become available after study analysis is completed, at least one year after study completion.
• IPD Sharing Access Criteria: Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No