Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04969289 |
| Other study ID # |
AAAT6680 |
| Secondary ID |
R21NR019181 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 26, 2021 |
| Est. completion date |
November 20, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
