Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT02847858
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Health -E-You is an interactive, individually tailored computer application (App) that was developed to educate adolescent girls about contraceptive methods and assist them in selecting a contraceptive method that meets their individual needs. The goal is to reduce disparities in unintended pregnancy rates among Hispanic adolescent females.
The App was designed in close collaboration with clinicians and Hispanic adolescents. Health-E You was designed to be used in conjunction with a clinical encounter to prime both the patient and provider prior to the face-to-face visit to facilitate the discussion and provision of appropriate contraception. It is founded on key principles of Social Cognitive Theory.
Through an interactive approach, Health-E-You assesses the users' sexual health risks, knowledge and contraceptive use history and preferences to facilitate a sense of agency and self-efficacy around selecting an effective contraceptive method. First, the user selects their preferred language (English or Spanish) and according to the selected language, the App provides a brief description of the module and consents the user to participate. It then assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to the truth vs. myth statements are then presented to the user as short, easy-to-read explanations. Next, the App assesses the user's individual contraceptive needs and preferences. The user is also screened for possible medical contraindications to contraceptive methods. Based on the user's input, the App provides individually tailored messaging and recommendations for contraceptive methods according to the user's own timeline for childbearing and their lifestyle preferences, past experiences and needs. The recommendations are presented on a visual continuum of effective contraceptive options based on desired duration of action and efficacy. Users then have the option to learn more about the recommended method(s) and they also have the option to learn more about any of the contraceptive options. Evidence-based contraceptive information is presented in a user-friendly format that includes YouTube style videos. Users can select to view brief video vignettes that feature clinicians who provide additional information about the method of interest and/or videos of diverse young women who discuss their experiences with each of the contraceptive methods. At the end of the App, adolescents are asked to select the method (s) they are most interested in using. They are also encouraged to use condoms to protect against sexually transmitted infections (STIs) and provided information about emergency contraception. Users can review a summary of a key information gathered from the App and are offered the opportunity to share that information with their clinician so that the clinician can better support the adolescent in selecting and using an effective and appropriate contraceptive method.
The objective of this study is to evaluate the effectiveness of Health-E You on its ability to address disparities in contraceptive knowledge, access and utilization among Hispanic adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized, with equal chance, to use the Health-E You App or to provide usual care (without the App). A total of 1400 Hispanic adolescents will be selected to participate in the study (700 at intervention clinics and 700 at the control clinics). The investigators hypothesize that adolescents who use the Health-E You App will have greater sexual health knowledge and will be more likely to use effective contraceptive than adolescent who do not use the App. The investigators will also evaluate the effectiveness of the App on its ability to improve the effectiveness and efficiency of the health visit. Participants will be asked to complete follow-up surveys immediately following the clinical encounter and at three and six months after the clinical encounter.
The ultimate goal of this study is address health disparities in the use of effective contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among at-risk Hispanic adolescent girls.
The App was designed in close collaboration with clinicians and Hispanic adolescents. Health-E You was designed to be used in conjunction with a clinical encounter to prime both the patient and provider prior to the face-to-face visit to facilitate the discussion and provision of appropriate contraception. It is founded on key principles of Social Cognitive Theory.
Through an interactive approach, Health-E-You assesses the users' sexual health risks, knowledge and contraceptive use history and preferences to facilitate a sense of agency and self-efficacy around selecting an effective contraceptive method. First, the user selects their preferred language (English or Spanish) and according to the selected language, the App provides a brief description of the module and consents the user to participate. It then assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to the truth vs. myth statements are then presented to the user as short, easy-to-read explanations. Next, the App assesses the user's individual contraceptive needs and preferences. The user is also screened for possible medical contraindications to contraceptive methods. Based on the user's input, the App provides individually tailored messaging and recommendations for contraceptive methods according to the user's own timeline for childbearing and their lifestyle preferences, past experiences and needs. The recommendations are presented on a visual continuum of effective contraceptive options based on desired duration of action and efficacy. Users then have the option to learn more about the recommended method(s) and they also have the option to learn more about any of the contraceptive options. Evidence-based contraceptive information is presented in a user-friendly format that includes YouTube style videos. Users can select to view brief video vignettes that feature clinicians who provide additional information about the method of interest and/or videos of diverse young women who discuss their experiences with each of the contraceptive methods. At the end of the App, adolescents are asked to select the method (s) they are most interested in using. They are also encouraged to use condoms to protect against sexually transmitted infections (STIs) and provided information about emergency contraception. Users can review a summary of a key information gathered from the App and are offered the opportunity to share that information with their clinician so that the clinician can better support the adolescent in selecting and using an effective and appropriate contraceptive method.
The objective of this study is to evaluate the effectiveness of Health-E You on its ability to address disparities in contraceptive knowledge, access and utilization among Hispanic adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized, with equal chance, to use the Health-E You App or to provide usual care (without the App). A total of 1400 Hispanic adolescents will be selected to participate in the study (700 at intervention clinics and 700 at the control clinics). The investigators hypothesize that adolescents who use the Health-E You App will have greater sexual health knowledge and will be more likely to use effective contraceptive than adolescent who do not use the App. The investigators will also evaluate the effectiveness of the App on its ability to improve the effectiveness and efficiency of the health visit. Participants will be asked to complete follow-up surveys immediately following the clinical encounter and at three and six months after the clinical encounter.
The ultimate goal of this study is address health disparities in the use of effective contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among at-risk Hispanic adolescent girls.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: