Trial Outcomes & Findings for A Trial of an Adolescent Male Sexual Health Intervention (NCT NCT04969289)

NCT ID: NCT04969289

Last Updated: 2024-07-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 119 participants
• Primary outcome timeframe: From day 1 of enrollment until the final day of enrollment (1 year)
• Results posted on: 2024-07-09

Participant Flow

From July 2021 to June 2022, 119 male participants were enrolled and randomized.

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.

Participant milestones

Measure	Dr. Eric Digital Health Intervention 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). Dr. 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.	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.
Overall Study STARTED	60	59
Overall Study COMPLETED	47	50
Overall Study NOT COMPLETED	13	9

Reasons for withdrawal

Measure	Dr. Eric Digital Health Intervention 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). Dr. 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.	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.
Overall Study Lost to Follow-up	13	9

Baseline Characteristics

A Trial of an Adolescent Male Sexual Health Intervention

Baseline characteristics by cohort

Measure	Dr. Eric Digital Health Intervention n=60 Participants 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.	Standard of Care n=59 Participants 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.	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	59 participants n=7 Participants	119 participants n=5 Participants
Condom use at last intercourse	36 Participants n=5 Participants	26 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Patients n=138 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	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.
Number of Eligible Participants Who Agreed to be Enrolled in the Study	119 participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Patients n=60 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=59 Participants 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.
Number of Participants That Are Lost to Follow up (at Each Time Point) 6 weeks	25 Participants	13 Participants
Number of Participants That Are Lost to Follow up (at Each Time Point) 13 weeks	19 Participants	13 Participants

PRIMARY outcome

Timeframe: From day 1 of enrollment until the final day of enrollment (1 year)

Population: Only includes participants from this intervention arm.

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.

Outcome measures

Measure	All Eligible Patients n=60 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	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.
Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY)	53 participants	—

PRIMARY outcome

Timeframe: From day 1 of enrollment until the final day of enrollment (1 year)

Population: Only includes participants from this intervention arm.

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.

Outcome measures

Measure	All Eligible Patients n=60 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	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.
The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY)	59 participants	—

PRIMARY outcome

Timeframe: 3 months

Population: Only includes participants from this intervention arm.

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.

Outcome measures

Measure	All Eligible Patients n=60 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	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.
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 outcome

Timeframe: 3 months (or 13 weeks)

Population: Calculated from participants who completed follow-up at 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.

Outcome measures

Measure	All Eligible Patients n=41 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=46 Participants 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.
Percentage of Condom Use Among Participants	34.6 percentage of episodes of condom-sex	37.3 percentage of episodes of condom-sex

PRIMARY outcome

Timeframe: 6 weeks

Population: Includes participants who completed follow-up at 6 weeks and were sexually active in the prior 4 weeks.

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.

Outcome measures

Measure	All Eligible Patients n=23 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=28 Participants 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.
Percentage of Condom Use Among Participants	82.5 percentage of episodes of condom-sex	47.5 percentage of episodes of condom-sex

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Patients n=41 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=46 Participants 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.
Number of Participants Who Had Intercourse Over the Past 4 Weeks	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 3 month (13 weeks)

Population: This count only includes participants who completed this question in the follow-up survey.

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.

Outcome measures

Measure	All Eligible Patients n=36 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=46 Participants 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.
Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months	23 Participants	29 Participants

SECONDARY outcome

Timeframe: 3 month (13 weeks)

Population: Only includes participants who completed this question in the follow-up survey.

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.

Outcome measures

Measure	All Eligible Patients n=42 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=46 Participants 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.
Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months	13 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Patients n=41 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=46 Participants 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.
Number of Participants Who Tested for HIV Over the Past 3 Months	9 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	All Eligible Patients n=26 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=24 Participants 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.
Number of Participants Who Consistently Used Condoms at Every Intercourse	12 participants	13 participants

SECONDARY outcome

Timeframe: 3 months (or 13 weeks)

Population: Calculated from participants who completed follow-up at 13 weeks and were sexually active.

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.

Outcome measures

Measure	All Eligible Patients n=26 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=24 Participants 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.
Number of Participants Who Used a Condom at Last Intercourse	18 participants	20 participants

SECONDARY outcome

Timeframe: 3 month (13 weeks)

Population: Only includes participants who completed this question in the follow-up survey.

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.

Outcome measures

Measure	All Eligible Patients n=26 Participants All eligible male patients aged 14-21 assessed for screening and eligible for enrollment	Standard of Care n=24 Participants 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.
Number of Participants Who Used Any Contraceptive Method at Last Intercourse	22 Participants	20 Participants

Adverse Events

Dr. Eric Digital Health Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lauren Chernick, MD, MSc

Columbia University

Phone: 212-305-9825

Email: lc2243@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place