N/A
N=119
A Trial of an Adolescent Male Sexual Health Intervention
Contraception Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04969289 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Eligible Participants Who Agreed to be Enrolled in the Study — 119 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dr. Eric Digital Health Intervention (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Male
- Sponsor
- Columbia University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eligible Participants Who Agreed to be Enrolled in the Study |
119 | — |
| PRIMARY Number of Participants That Are Lost to Follow up (at Each Time Point) |
25; 13; 19; 13 | — |
| PRIMARY Total Number of Participants Who Demonstrated Acceptability (Intervention Arm ONLY) |
53 | — |
| PRIMARY The Number of Participants Who Interacted With All 5 Educational Modules (Intervention Arm ONLY) |
59 | — |
| PRIMARY Number of Participants Who Opt Out of the Texting Messaging Component of the Program (Intervention Arm ONLY) |
14 | — |
| PRIMARY Percentage of Condom Use Among Participants |
82.5; 47.5 | — |
| PRIMARY Percentage of Condom Use Among Participants |
82.5; 47.5 | — |
| SECONDARY Number of Participants Who Had Intercourse Over the Past 4 Weeks |
5; 9 | — |
| SECONDARY Number of Participants Who Talked to a Partner About Ways to Prevent Pregnancy Over the Past 3 Months |
23; 29 | — |
| SECONDARY Number of Participants Who Tested for a Sexually Transmitted Infection Over the Past 3 Months |
13; 15 | — |
| SECONDARY Number of Participants Who Tested for HIV Over the Past 3 Months |
9; 15 | — |
| SECONDARY Number of Participants Who Consistently Used Condoms at Every Intercourse |
12; 13 | — |
| SECONDARY Number of Participants Who Used a Condom at Last Intercourse |
18; 20 | — |
| SECONDARY Number of Participants Who Used Any Contraceptive Method at Last Intercourse |
22; 20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04969289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.