Sexually Transmitted DiseasesNCT06525064
Health-E You Efficacy Trial for Male Adolescents
A study testing Health-E You app in people with Sexually Transmitted Diseases and Sexual Health, run by Johns Hopkins University at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Sexual Health, Reproductive Health
- What is being tested?
- Health-E You app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,752 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Jun 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Assigned male sex at birth
- Age 13 to 21 years old
- English and/or Spanish as preferred language to read, listen, and converse
- Self-reported engagement in vaginal and/or anal sex in the past 12 months
- Access to phone or internet for follow-up study activities
Who cannot join
- Aged 12 or younger or older than 21
- Primary language other than English or Spanish
- Not able to provide informed consent
- Unable to communicate due to cognitive, mental, language, or other difficulties
- Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex.
- Previous participation in a Health-E You study activity or the app
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sofia Osio, MSPH contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Arik Marcell, MD, MPH, 443-676-2378, amarcell@jhu.edu
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Emmanuel Chandler, MD, 513-636-4200, emmanuel.chandler@cchmc.org
- Recruiting
Penn State Health
Hershey, Pennsylvania, 17033
Ryan Spotts, MD, 800-243-1455, rspotts@pennstatehealth.psu.edu
Brody Lipsett, MD, 717-361-0666, blipsett@pennstatehealth.psu.edu
- Recruiting
Mount Sinai Health System
New York, New York, 10128
Wendy Neal, MD, wendy.neal@mountsinai.org
- Recruiting
UCSF Benioff Children's Hospital - Oakland
Oakland, California, 94609
Lela Bachrach, MD, MS, 510-428-3000, lela.bachrach@ucsf.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Renata Renata, MD, MPH, ScM, 215-590-3537, sandersr2@chop.edu
- Recruiting
Upstate University Hospital
Syracuse, New York, 13210
Aimee Steiniger, MD, 315-464-4357, steiniga@upstate.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20012
Sharyn Malcolm, MD, MPH, 202-476-2904, smalcolm@childrensnational.org
About this study
Official title: Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt
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.
Read the detailed description
Health-E You is a pre-visit, web-based mobile app designed to support an adolescent male youth and his clinician in discussing SRH topics and care. It is shared with an adolescent patient prior to a clinic visit, and contains initial questions that subsequently provide the patient with individually-tailored health information. In addition, the app provides relevant information to the clinician on patients' SRH to optimize the time together as part of the visit. In total, the app takes approximately 10-15 minutes to complete. The purpose of this study is to evaluate the efficacy of the Health-E You app among male youth ages 13-21 using a cluster-randomized stepped-wedge design. A participant will be considered to have completed the study if the participant has completed the baseline assessment, worked through the app, an immediate follow-up assessment, and a 2-month post-visit follow-up assessment. The end of the study is defined as completion of the 2-month follow-up assessment. Hypotheses include compared to usual care, app users will have greater improvements in male method use behaviors (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (STI) prevention methods, male method use self-efficacy, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.
- Being tested
- Health-E You app
- Keywords
- male adolescent, condom use, mhealth
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-E You appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No 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. |
| Intervention Group | Experimental | 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. Receives: Other: Health-E You app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Condom Use Self-Efficacy Scale
Higher score indicates greater self-efficacy for correct use of male condoms. This measure is scaled with range from 1 (very difficult) to 5 (very easy); range 7-35.
Measured: Baseline, 24 hours after visit, 2-month follow-up
Perceived efficacy in patient-physician interactions (PEPPI)
Higher score indicates greater efficacy in patient-physician interaction about sexual and reproductive health. This measure is scaled with range from 1 (not at all confident) to 5 (very confident); range 5-25.
Measured: Baseline, 24 hours after visit, 2-month follow-up
Frequency condom use
Measures frequency condom use with main \& non-main partners in past year and last 2 months
Measured: Baseline, 2-month follow-up
Sexual and reproductive care receipt
Measures receipt of the recommended sexual and reproductive care package, based on national guidelines outlined by the Centers for Disease Control and Prevention (CDC) Office of Population Affairs (OPA) Quality Family Planning guidance \& American Academy of Pediatrics' Bright Futures
Measured: Baseline, 24 hours after visit, 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start2 Jun 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will use a cluster-randomized stepped-wedge design that is a type of one-way crossover design. Under this design, each clinic will start the study under the control condition that involves standard usual care, and end the study in the intervention condition.
- Masking
- None (open label)
- Enrolment
- 2,752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Arik V Marcell, MD, MPH, Principal investigator, Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525064
- Sponsor's protocol ID
- IRB00424416
- Other IDs
- R01HD109141
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final version of collected data will be made available within thirty (30) months after the end of the data collection. Data will be preserved and made accessible along with the data codebook and other relevant documentation via the chosen repository. The investigators will make the data available through restricted/controlled access. Open Inter-university Consortium for Political and Social Research's (ICPSR's) Traditional Restricted Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to approved researchers.
Publications
Akande M, Aturaliya R, Osio Smith S, Smith A, Arrington-Sanders R, Tebb K, Marcell AV. Integrating Young Male Voices to Enhance Sexual and Reproductive Healthcare Uptake of Innovative Pre-Clinic Technology. Journal of Adolescent Health. 2024;74(3 Suppl):S2.
Tebb KP, Rodriguez F, Pollack LM, Adams S, Rico R, Renteria R, Trieu SL, Hwang L, Brindis CD, Ozer E, Puffer M. Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu. Contraception. 2021 Sep;104(3):246-253. doi: 10.1016/j.contraception.2021.03.004. Epub 2021 Mar 17.
PubMed 33744300Marcell AV, Smith AD, Osio Smith S, Akande M, Rohlff S, Arrington-Sanders R, Tebb K. A Previsit Mobile Health App (Health-E You/Salud iTu) for Male Adolescents to Promote Sexual and Reproductive Health Care Receipt: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 15;14:e77780. doi: 10.2196/77780.
PubMed 41092393
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-E You/Salud iTu: Pre-visit Mobile Health App for Male Adolescents to Promote Adolescent-centered Sexual & Reproductive Healthcare Receipt
- ClinicalTrials.gov ID
- NCT06525064
- Acronym / sponsor ID
- IRB00424416
- Keywords
- male adolescent, condom use, mhealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,752 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Health-E You is a pre-visit, web-based mobile app designed to support an adolescent male youth and his clinician in discussing SRH topics and care. It is shared with an adolescent patient prior to a clinic visit, and contains initial questions that subsequently provide the patient with individually-tailored health information. In addition, the app provides relevant information to the clinician on patients' SRH to optimize the time together as part of the visit. In total, the app takes approximately 10-15 minutes to complete. The purpose of this study is to evaluate the efficacy of the Health-E You app among male youth ages 13-21 using a cluster-randomized stepped-wedge design. A participant will be considered to have completed the study if the participant has completed the baseline assessment, worked through the app, an immediate follow-up assessment, and a 2-month post-visit follow-up assessment. The end of the study is defined as completion of the 2-month follow-up assessment. Hypotheses include compared to usual care, app users will have greater improvements in male method use behaviors (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (STI) prevention methods, male method use self-efficacy, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a cluster-randomized stepped-wedge design that is a type of one-way crossover design. Under this design, each clinic will start the study under the control condition that involves standard usual care, and end the study in the intervention condition.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No 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. |
| Intervention Group | Experimental | Other: Health-E You appWhen 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Assigned male sex at birth
- Age 13 to 21 years old
- English and/or Spanish as preferred language to read, listen, and converse
- Self-reported engagement in vaginal and/or anal sex in the past 12 months
- Access to phone or internet for follow-up study activities
Key exclusion criteria (6 listed)
- Aged 12 or younger or older than 21
- Primary language other than English or Spanish
- Not able to provide informed consent
- Unable to communicate due to cognitive, mental, language, or other difficulties
- Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-E You appWhen 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. | Other | Intervention Group |
Primary outcome
Correct Condom Use Self-Efficacy Scale
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Higher score indicates greater self-efficacy for correct use of male condoms. This measure is scaled with range from 1 (very difficult) to 5 (very easy); range 7-35.
Perceived efficacy in patient-physician interactions (PEPPI)
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Higher score indicates greater efficacy in patient-physician interaction about sexual and reproductive health. This measure is scaled with range from 1 (not at all confident) to 5 (very confident); range 5-25.
Frequency condom use
Time frame: Baseline, 2-month follow-up
Measures frequency condom use with main \& non-main partners in past year and last 2 months
Sexual and reproductive care receipt
Time frame: Baseline, 24 hours after visit, 2-month follow-up
Measures receipt of the recommended sexual and reproductive care package, based on national guidelines outlined by the Centers for Disease Control and Prevention (CDC) Office of Population Affairs (OPA) Quality Family Planning guidance \& American Academy of Pediatrics' Bright Futures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- BackgroundAkande M, Aturaliya R, Osio Smith S, Smith A, Arrington-Sanders R, Tebb K, Marcell AV. Integrating Young Male Voices to Enhance Sexual and Reproductive Healthcare Uptake of Innovative Pre-Clinic Technology. Journal of Adolescent Health. 2024;74(3 Suppl):S2.
- Background: PubMed 33744300Tebb KP, Rodriguez F, Pollack LM, Adams S, Rico R, Renteria R, Trieu SL, Hwang L, Brindis CD, Ozer E, Puffer M. Improving contraceptive use among Latina adolescents: A cluster-randomized controlled trial evaluating an mHealth application, Health-E You/Salud iTu. Contraception. 2021 Sep;104(3):246-253. doi: 10.1016/j.contraception.2021.03.004. Epub 2021 Mar 17.
- Derived from this study: PubMed 41092393Marcell AV, Smith AD, Osio Smith S, Akande M, Rohlff S, Arrington-Sanders R, Tebb K. A Previsit Mobile Health App (Health-E You/Salud iTu) for Male Adolescents to Promote Sexual and Reproductive Health Care Receipt: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 15;14:e77780. doi: 10.2196/77780.
- Individual participant dataSharing planned: No. The final version of collected data will be made available within thirty (30) months after the end of the data collection. Data will be preserved and made accessible along with the data codebook and other relevant documentation via the chosen repository. The investigators will make the data available through restricted/controlled access. Open Inter-university Consortium for Political and Social Research's (ICPSR's) Traditional Restricted Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to approved researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sofia Osio, MSPH contact
Arik V Marcell, MD, MPH principal investigator
Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-E You app in people with Sexually Transmitted Diseases and Sexual Health, run by Johns Hopkins University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arik V Marcell, MD, MPH (4432878946, amarcell@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct Condom Use Self-Efficacy Scale (time frame: Baseline, 24 hours after visit, 2-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525064, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.