NCT04969289: DrEric

A Trial of an Adolescent Male Sexual Health Intervention

Completed NA Results posted Last updated 9 July 2024

What this trial tests

NA trial testing Dr. Eric Digital Health Intervention in Contraception Behavior in 119 participants. Completed in 20 November 2022.

Timeline

26 July 2021

Primary endpoint
20 November 2022

20 November 2022

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	119
Start date	26 July 2021
Primary completion	20 November 2022
Estimated completion	20 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Dr. Eric Digital Health Intervention

Conditions studied

• Contraception Behavior — all drugs for Contraception Behavior →

Sponsor

Columbia University

Who can join

Adults 14 to 21, male only, with Contraception Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Eligible Participants Who Agreed to be Enrolled in the Study Primary · From day 1 of enrollment until the final day of enrollment (1 year)

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.

Group	Value	95% CI
All Eligible Patients	119

Number of Participants That Are Lost to Follow up (at Each Time Point) Primary · 6 and 13 weeks

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 weeks

Group	Value	95% CI
Dr. Eric Digital Health Intervention	25
Standard of Care	13

13 weeks

Group	Value	95% CI
Dr. Eric Digital Health Intervention	19
Standard of Care	13

Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY) Primary · From day 1 of enrollment until the final day of enrollment (1 year)

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.

Group	Value	95% CI
Intervention Participants	53

The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY) Primary · From day 1 of enrollment until the final day of enrollment (1 year)

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.

Group	Value	95% CI
Intervention Arm	59

Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY) Primary · 3 months

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.

Group	Value	95% CI
Intervention Arm	14

Percentage of Condom Use Among Participants Primary · 3 months (or 13 weeks)

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.

Group	Value	95% CI
Dr. Eric Digital Health Intervention	34.6
Standard of Care	37.3

Percentage of Condom Use Among Participants Primary · 6 weeks

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.

Group	Value	95% CI
Dr. Eric Digital Health Intervention	82.5
Standard of Care	47.5

Number of Participants Who Had Intercourse Over the Past 4 Weeks Secondary · 3 month (13 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.

Group	Value	95% CI
Intervention Participants Who Completed 3 Month Follow-up Questions	5
Control Participants Who Completed 3 Month Follow-up Questions	9

Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months Secondary · 3 month (13 weeks)

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.

Group	Value	95% CI
Intervention Participants Who Completed 3 Month Follow-up Questions	23
Control Participants Who Completed 3 Month Follow-up Questions	29

Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months Secondary · 3 month (13 weeks)

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.

Group	Value	95% CI
Intervention Participants Who Completed 3 Month Follow-up Questions	13
Control Participants Who Completed 3 Month Follow-up Questions	15

Number of Participants Who Tested for HIV Over the Past 3 Months Secondary · 3 month (13 weeks)

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.

Group	Value	95% CI
Intervention Participants Who Completed 3 Month Follow-up Questions	9
Control Participants Who Completed 3 Month Follow-up Questions	15

Number of Participants Who Consistently Used Condoms at Every Intercourse Secondary · 3 months (or 13 weeks)

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.

Group	Value	95% CI
Dr. Eric Digital Health Intervention	12
Standard of Care	13

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of a Digital Intervention to Improve the Sexual Health of Adolescent and Young Adult Male Emergency Department Patients.
   Chernick LS, Bugaighis M, Hochster D, Daylor V, et al · · 2025 · cited 2× · PMID 39387726 · DOI 10.1016/j.jadohealth.2024.08.020