A Trial of an Adolescent Male Sexual Health Intervention

NCT04969289 | Completed Results DMC

• 2 other identifiers: AAAT6680R21NR019181
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception Behavior

Keywords

Digital health; Sexual health; Sexual education; Adolescent health; Mobile health

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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.

  6 and 13 weeks

• 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.

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

• 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.

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

• 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.

  3 months

• 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.

  3 months (or 13 weeks)

• 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.

  6 weeks

Secondary Outcomes (7)

• Number of Participants Who Had Intercourse Over the Past 4 Weeks

  3 month (13 weeks)

• Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months

  3 month (13 weeks)

• Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months

  3 month (13 weeks)

• Number of Participants Who Tested for HIV Over the Past 3 Months

  3 month (13 weeks)

• Number of Participants Who Consistently Used Condoms at Every Intercourse

  3 months (or 13 weeks)

Study Arms (2)

Dr. Eric Digital Health Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Dr. Eric Digital Health Intervention BEHAVIORAL

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.

Dr. Eric Digital Health Intervention

Eligibility Criteria

• Age: 14 Years - 21 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ED male adolescent patients aged 14-21 years
• sexually active (vaginal intercourse) with females in the past 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10528, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Limitations and Caveats

This study included individuals who predominately identified as Hispanic and "more than one race"; the investigators did not ask for more granular race and ethnicity data. Also, the investigators were limited in their ability to assess additional measures of adoption and fidelity such as time spent on the app, which would have represented real use. For the primary outcome, the investigators measured condom use as a group; different results could occur if they measured use by person.

Results Point of Contact

• Title: Lauren Chernick, MD, MSc
• Organization: Columbia University

lc2243@columbia.edu

212-305-9825

Study Officials

• Lauren Chernick, MD MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be electronic. If assessed via phone call, outcome assessors will be blinded to study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: Intervention participants receive the Dr. Eric program. Control participants will receive the standard of care.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 20, 2021
• Study Start: July 26, 2021
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: July 9, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after study analysis is completed, at least one year after study completion.
• Access Criteria: Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)