A Trial of an Adolescent Male Sexual Health Intervention

Study Overview
=================
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.

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

Conditions
-----------------
Contraception Behavior

Intervention / Treatment
-----------------
* Behavioral: Dr. Eric Digital Health Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dr. Eric Digital Health Intervention<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>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 |
| --- | --- | --- |
| Rate of consistent condom use | This outcome is designed to measure efficacy. This will be measured as a rate. It will be calculated as the total number of episodes of vaginal intercourse divided by the total number of times a male condom was used over the past 4 weeks, with a score of 1 representing consistent condom use. These questions will be asked via self-reported questionnaire. The range in means would be from 0 (meaning loss to follow up, non-condom use) to 1 (consistent condom use). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participant refusal | This outcome is designed to measure feasibility - the extent to which an innovation can be used in a setting. The investigators will measure the percentage of participants who are eligible but decline to be enrolled into the study. | Day 1 | 
| Percentage of loss to follow up | This outcome is to measure feasibility for both arms. Feasibility is the extent to which an innovation can be used in a setting. The investigators will measure the percentage of those participants in each arm that are lost to follow up over the total number of participants in that respective arm. | 3 months | 
| Average score on the Acceptability of Intervention Measure Scale | This outcome is to measure acceptability for the intervention group only. Acceptability is the extent to which the innovation is agreeable to a stakeholder and will be assessed using the validated scale, Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. This will be asked via questionnaire. | Day 1 | 
| Average time to use app | This outcome if for the intervention group only. The investigators will assess adoption by measuring participant time using the app. This data will be recorded by the app and measured in minutes. | Day 1 | 
| Percentage of educational modules that the participant engages with | This outcome is for the intervention group only. The investigators will assess adoption by measuring the number of educational modules that the participants engages with while using the app divided by the number of educational modules in the app. This data will be recorded by the app. | Day 1 | 
| Rate of texting interactivity | This outcome is for the intervention group only. The investigators will assess adoption by dividing the total number of interactive text messages sent to that participant by the number of text messages he responds to. This data will be recorded from the app. The higher the rate, the more interactive the participant is with the program. | 3 months | 
| Percentage of opt outs | This outcome is for the intervention group only. Fidelity is the extent to which an intervention is used as intended. The investigators will collect data via the mobile platform provider to assess fidelity. This outcome will be calculated by dividing the number of participants in the intervention group by the number of participants who opt out of the text program. Lower opt out percentages correlate with better fidelity. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital health, Sexual health, Sexual education, Adolescent health, Mobile health