Health-E You App for Adolescent Sexual and Reproductive Health

Overseen By Arik V Marcell, MD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Age, Language, Consent, Communication, Activity, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

1866 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Health-E You app treatment for adolescent sexual and reproductive health?

Preliminary findings suggest that the Health-E You app is feasible to implement, acceptable to Latina adolescents, and improves sexual health knowledge and interest in selecting an effective contraceptive method when used with a healthcare visit. ^{1 2 3 4 5}

Is the Health-E You app safe for use in adolescents?

The Health-E You app has been found to be feasible and acceptable for use among Latina adolescents, improving their sexual health knowledge and interest in contraception. There is no specific mention of safety concerns in the available research, suggesting it is generally safe for use in this population. ^{1 3 5 6 7}

How is the Health-E You app treatment different from other treatments for adolescent sexual and reproductive health?

The Health-E You app is unique because it is a mobile application designed to improve sexual health knowledge and encourage effective contraceptive use among adolescents, particularly Latina adolescents, by integrating with healthcare visits. Unlike traditional methods, it offers a patient-centered, interactive experience that is accessible via mobile devices, making it more engaging and convenient for young users. ^{1 5 6 8 9}

What is the purpose of this trial?

This study will involve evaluating Health-E You/Salud ìTu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (SRH) topics and care. It will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

Research Team

Arik V Marcell, MD, MPH

Principal Investigator

Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

Eligibility Criteria

This trial is for male adolescents focusing on sexual and reproductive health, including prevention of sexually transmitted infections. Participants should be comfortable using a mobile app to discuss these topics with their clinicians.

Inclusion Criteria

I prefer to communicate in English or Spanish.

I have had vaginal or anal sex in the last year.

Access to phone or internet for follow-up study activities

Exclusion Criteria

My primary language is not English or Spanish.

I have not had vaginal or anal sex in the last year.

I am unable to understand or sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Pre-visit App Completion

Participants complete the Health-E You app prior to their clinic visit

10-15 minutes

1 session (virtual)

Clinic Visit

Participants attend a clinic visit where the app's recommendations are discussed with the clinician

1 day

1 visit (in-person)

Immediate Follow-up

Participants complete an immediate follow-up assessment 24 hours after the clinic visit

1 day

1 session (virtual)

2-Month Follow-up

Participants are monitored for changes in sexual and reproductive health behaviors and knowledge

2 months

1 session (virtual)

Treatment Details

Interventions

• Health-E You app

Trial Overview The study tests the Health-E You/Salud ìTu™ app's effectiveness in supporting discussions about sexual and reproductive health between young males and their doctors, using a stepped wedge cluster randomized controlled trial design.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

When clinics are in the intervention condition, all patients presenting for any reason will get a study weblink 24 hours before the visit; walk-ins will get a study link code in clinic. If the participants agree to participate and meet study criteria, the participants will get a survey link and then Health-E You content to complete before the visit. Previously enrolled males will not be enrolled again to maintain the research study's integrity. Thus, participants will only have one opportunity for administration to the Health-E You app. Participants will be considered to have completed the Health-E You app if the participants answer all of the app's initial tailoring questions and receive recommendations for SRH topics to discuss with the clinician. As a technology-based intervention, no direct interactions with interventionists with participants are required.

Group II: Control Group Active Control 1 Intervention

When clinics are in the control condition, patients will receive usual care. Before the visit eligible participants will receive a weblink to study information, and if agree to participate, the survey. The participants will not be presented Health-E You content and clinicians will not receive output to prime the visit; the participants will receive usual care as typical. Previously enrolled control males will not be enrolled during intervention periods to maintain the research study's integrity.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A mobile health app designed to promote safe sex and increase condom use among youth was developed based on direct input from 17 young participants (15 individual interviews and 2 focus groups) in Stockholm, emphasizing the importance of youth engagement in intervention design.

The app's content includes sex education, practical condom usage tips, and supportive messaging, with various delivery modes suggested by youth, such as text messages and videos, highlighting the need for engaging and relatable educational tools to effectively promote safe sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. Nielsen, A., Bågenholm, A., De Costa, A.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Evaluation of Contraception Education and Health Promotion Applications for Patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A multi-media digital intervention to improve the sexual and reproductive health of female adolescent emergency department patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An Electronic Sexual Health Module for Hospitalized Adolescent Girls. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Development of a Mobile Phone App to Promote Safe Sex Practice Among Youth in Stockholm, Sweden: Qualitative Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of a Novel Interactive Website to Inform Adolescent and Young Adult Decision-Making about Contraception. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health Contraception Decision Support Intervention for Latina Adolescents: Implementation Evaluation for Use in School-Based Health Centers. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Promoting Adolescent Sexual and Reproductive Health in North America Using Free Mobile Apps: Environmental Scan. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Crush: A Randomized Trial to Evaluate the Impact of a Mobile Health App on Adolescent Sexual Health. [2023]