Contraception Behavior
Conditions
Keywords
Digital health, Sexual health, Sexual education, Adolescent health, Mobile health
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.
Interventions
BEHAVIORALDr. Eric Digital Health Intervention
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.
Sponsors
National Institute of Nursing Research (NINR)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be electronic. If assessed via phone call, outcome assessors will be blinded to study arm.
Intervention model description
Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.
Eligibility
Sex/Gender
MALE
Age
14 Years to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Participants Who Agreed to be Enrolled in the Study | 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. |
| Number of Participants That Are Lost to Follow up (at Each Time Point) | 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. |
| Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY) | 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. |
| The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY) | 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. |
| Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY) | 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. |
| Percentage of Condom Use Among Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Intercourse Over the Past 4 Weeks | 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. |
| Number of Participants Who Used Any Contraceptive Method at Last Intercourse | 3 month (13 weeks) | Efficacy, Used any method of contraception at last intercourse: 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. |
| Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months | 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. |
| Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months | 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. |
| Number of Participants Who Tested for HIV Over the Past 3 Months | 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. |
| Number of Participants Who Consistently Used Condoms at Every Intercourse | 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. |
| Number of Participants Who Used a Condom at Last Intercourse | 3 months (or 13 weeks) | Efficacy, Use a condom at last intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks and were sexually active. Answers are binary (yes/no) to the question if a condom was used at last intercourse. |
Countries
United States
Participant flow
Recruitment details
From July 2021 to June 2022, 119 male participants were enrolled and randomized.
Pre-assignment details
The investigators excluded 9 patients in the intervention arm and 13 patients from the standard control arm in the analysis as they were lost to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Dr. Eric Digital Health Intervention Dr. Eric Digital Health Intervention: Dr. Eric is a user-informed, theory-based, digital health intervention that aims to improve adolescent male sexula health. 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. | 60 |
| Standard of Care 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. | 59 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 9 |
Baseline characteristics
| Characteristic | Dr. Eric Digital Health Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 35 Participants | 77 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 24 Participants | 42 Participants |
| Condom use at last intercourse | 36 Participants | 26 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 47 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 12 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 60 participants | 59 participants | 119 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 60 Participants | 59 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 0 / 60 | 0 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Number of Eligible Participants Who Agreed to be Enrolled in the Study
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.
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Number of Eligible Participants Who Agreed to be Enrolled in the Study | 119 participants |
Primary
Number of Participants That Are Lost to Follow up (at Each Time Point)
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.
Time frame: 6 and 13 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Patients | Number of Participants That Are Lost to Follow up (at Each Time Point) | 6 weeks | 25 Participants |
| All Eligible Patients | Number of Participants That Are Lost to Follow up (at Each Time Point) | 13 weeks | 19 Participants |
| Standard of Care | Number of Participants That Are Lost to Follow up (at Each Time Point) | 6 weeks | 13 Participants |
| Standard of Care | Number of Participants That Are Lost to Follow up (at Each Time Point) | 13 weeks | 13 Participants |
Primary
Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY)
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.
Time frame: 3 months
Population: Only includes participants from this intervention arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY) | 14 participants who opted out of texting |
Primary
Percentage of Condom Use Among Participants
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.
Time frame: 6 weeks
Population: Includes participants who completed follow-up at 6 weeks and were sexually active in the prior 4 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Percentage of Condom Use Among Participants | 82.5 percentage of episodes of condom-sex |
| Standard of Care | Percentage of Condom Use Among Participants | 47.5 percentage of episodes of condom-sex |
Primary
Percentage of Condom Use Among Participants
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.
Time frame: 3 months (or 13 weeks)
Population: Calculated from participants who completed follow-up at 13 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Percentage of Condom Use Among Participants | 34.6 percentage of episodes of condom-sex |
| Standard of Care | Percentage of Condom Use Among Participants | 37.3 percentage of episodes of condom-sex |
Primary
The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)
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.
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
Population: Only includes participants from this intervention arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY) | 59 participants |
Primary
Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)
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.
Time frame: From day 1 of enrollment until the final day of enrollment (1 year)
Population: Only includes participants from this intervention arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY) | 53 participants |
Secondary
Number of Participants Who Consistently Used Condoms at Every Intercourse
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.
Time frame: 3 months (or 13 weeks)
Population: Calculated from participants who completed follow-up at 13 weeks and were sexually active in the past 3 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Consistently Used Condoms at Every Intercourse | 12 participants |
| Standard of Care | Number of Participants Who Consistently Used Condoms at Every Intercourse | 13 participants |
Secondary
Number of Participants Who Had Intercourse Over the Past 4 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.
Time frame: 3 month (13 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Had Intercourse Over the Past 4 Weeks | 5 Participants |
| Standard of Care | Number of Participants Who Had Intercourse Over the Past 4 Weeks | 9 Participants |
Secondary
Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months
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.
Time frame: 3 month (13 weeks)
Population: This count only includes participants who completed this question in the follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months | 23 Participants |
| Standard of Care | Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months | 29 Participants |
Secondary
Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months
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.
Time frame: 3 month (13 weeks)
Population: Only includes participants who completed this question in the follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months | 13 Participants |
| Standard of Care | Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months | 15 Participants |
Secondary
Number of Participants Who Tested for HIV Over the Past 3 Months
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.
Time frame: 3 month (13 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Tested for HIV Over the Past 3 Months | 9 Participants |
| Standard of Care | Number of Participants Who Tested for HIV Over the Past 3 Months | 15 Participants |
Secondary
Number of Participants Who Used a Condom at Last Intercourse
Efficacy, Use a condom at last intercourse: This outcome is designed to measure efficacy, is a self-reported outcome and only includes participants who completed follow-up at 13 weeks and were sexually active. Answers are binary (yes/no) to the question if a condom was used at last intercourse.
Time frame: 3 months (or 13 weeks)
Population: Calculated from participants who completed follow-up at 13 weeks and were sexually active.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Used a Condom at Last Intercourse | 18 participants |
| Standard of Care | Number of Participants Who Used a Condom at Last Intercourse | 20 participants |
Secondary
Number of Participants Who Used Any Contraceptive Method at Last Intercourse
Efficacy, Used any method of contraception at last intercourse: 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.
Time frame: 3 month (13 weeks)
Population: Only includes participants who completed this question in the follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Number of Participants Who Used Any Contraceptive Method at Last Intercourse | 22 Participants |
| Standard of Care | Number of Participants Who Used Any Contraceptive Method at Last Intercourse | 20 Participants |