Clinical trial NCT04969289: A Trial of an Adolescent Male Sexual Health Intervention
Official title: A Digital Intervention to Improve the Sexual and Reproductive Health of Male Adolescent Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: Digital health
Sexual health
Sexual education
Adolescent health
Mobile health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-07-20
Enrollment: 119
Sex: MALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Eligible Participants Who Agreed to be Enrolled in the Study
timeFrame: From day 1 of enrollment until the final day of enrollment (1 year)
measure: Number of Participants That Are Lost to Follow up (at Each Time Point)
timeFrame: 6 and 13 weeks
measure: Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)
timeFrame: From day 1 of enrollment until the final day of enrollment (1 year)
measure: The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)
timeFrame: From day 1 of enrollment until the final day of enrollment (1 year)
measure: Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY)
timeFrame: 3 months
measure: Percentage of Condom Use Among Participants
timeFrame: 3 months (or 13 weeks)
measure: Percentage of Condom Use Among Participants
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants Who Had Intercourse Over the Past 4 Weeks
timeFrame: 3 month (13 weeks)
measure: Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months
timeFrame: 3 month (13 weeks)
measure: Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months
timeFrame: 3 month (13 weeks)
measure: Number of Participants Who Tested for HIV Over the Past 3 Months
timeFrame: 3 month (13 weeks)
measure: Number of Participants Who Consistently Used Condoms at Every Intercourse
timeFrame: 3 months (or 13 weeks)
measure: Number of Participants Who Used a Condom at Last Intercourse
timeFrame: 3 months (or 13 weeks)
measure: Number of Participants Who Used Any Contraceptive Method at Last Intercourse
timeFrame: 3 month (13 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Lauren Chernick, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: