A Trial of an Adolescent Male Sexual Health Intervention
Condition: Contraception Behavior
Study type: Interventional

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.
    

Intervention name(s): Dr. Eric Digital Health Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Digital health; Sexual health; Sexual education; Adolescent health; Mobile health