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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD109141 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health-E You app | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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 | Baseline, 24 hours after visit, 2-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arik V Marcell, MD, MPH | Contact | 4432878946 | amarcell@jhu.edu | |
| Sofia Osio, MSPH | Contact | sosiosm1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arik V Marcell, MD, MPH | Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital - Oakland | Recruiting | Oakland | California | 94609 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 33744300 | Background | 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. | |
| 41092393 |
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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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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20012 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Mount Sinai Health System | Recruiting | New York | New York | 10128 | United States |
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| Upstate University Hospital | Recruiting | Syracuse | New York | 13210 | United States |
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| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Penn State Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Derived |
| Marcell 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |