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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health-E You App Participants | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents | Behavioral | School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics). |
| Measure | Description | Time Frame |
|---|---|---|
| Contraception Use Self-efficacy Scale Score (Aim 1b) | The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy) | Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline) |
| Contraception Use Self-efficacy Scale Score (Aim 1c) | The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy | Baseline, 3 months, 6 months |
| Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) | Recorded via self-administered online survey | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a) | The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome. | Immediate pre-app (Baseline), Immediate post-app (< 1 hour) |
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Inclusion Criteria:
Female 14-18 years of age Hispanic/Latina English or Spanish-speaker Has had sexual intercourse
Exclusion Criteria:
Currently pregnant Currently using an intrauterine device or implant contraceptive method Male Under 14 or over 19 years of age Not sexually active Non-Hispanic / Latina
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Tebb, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belmont Wellness Center | Los Angeles | California | United States | |||
| Carson Wellness Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30869649 | Derived | Tebb KP, Leng Trieu S, Rico R, Renteria R, Rodriguez F, Puffer M. A Mobile Health Contraception Decision Support Intervention for Latina Adolescents: Implementation Evaluation for Use in School-Based Health Centers. JMIR Mhealth Uhealth. 2019 Mar 14;7(3):e11163. doi: 10.2196/11163. | |
| 29326184 | Derived | Tebb KP, Rodriguez F, Pollack LM, Trieu SL, Hwang L, Puffer M, Adams S, Ozer EM, Brindis CD. 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. BMJ Open. 2018 Jan 10;8(1):e018201. doi: 10.1136/bmjopen-2017-018201. |
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Individuals were recruited from 18 participating school-based health centers in the Los Angeles UnifiedSchool District starting August 2016 and ending May 31, 2018. Clinic staff provided all female youth who entered the clinic an opportunity to use the iPad with the intervention app (baseline questionnaire for the control group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Health-E You Intervention Arm | Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm. |
| FG001 | Control Arm | Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Health-E You Intervention Arm | Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Contraception Use Self-efficacy Scale Score (Aim 1b) | The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy) | All participants for whom a self-efficacy score was recorded either at Baseline or at Post-visit Follow-up | Posted | Mean | Standard Deviation | Scores on a scale | Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline) |
|
This study was of minimal risk to participants. Participants were enrolled in the study for a total of 6 months from completion of baseline to end of follow-up. Adverse event data was collected during this time frame.
There were no adverse events that occurred during this study. This study was of minimal risk to participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Health-E You Intervention Arm | Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Tebb | University of California San Francisco | 415-514-0941 | Kathleen.Tebb@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Sep 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047568 | Unsafe Sex |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b) | The single yes/no item was self-administered in an online survey | Post-visit Follow-up (48 hours after Baseline) |
| Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a) | Recorded via self-administered online survey | Post-visit Follow-up |
| Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1) | Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Post-study completion |
| Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2) | Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Post-study completion |
| Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3) | Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Post-study completion |
| Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4) | Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Post-study completion |
| Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Immediate Follow-up |
| Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Immediate Follow-up |
| Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Immediate Follow-up |
| Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Immediate Follow-up |
| Los Angeles |
| California |
| United States |
| Control Arm |
Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | All data was collected using a mobile tablet in a study site. All information was self-reported by participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reason for visit related to reproductive health services | Did the participant visit the clinic for reproductive health or birth control related services. Data was collected on a mobile tablet device in the clinic as a part of a survey. | Count of Participants | Participants |
|
| Had sex in the past 3 months | Participants indicated whether or not they had sex in the past 3 months in the Baseline, 3-Month, and 6-Month online surveys. | Count of Participants | Participants |
|
Usual care (app not offered) |
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| Primary | Contraception Use Self-efficacy Scale Score (Aim 1c) | The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy | All participants for whom a self-efficacy score was recorded at Baseline or at 3 months or at 6 months | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 3 months, 6 months |
|
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| Primary | Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) | Recorded via self-administered online survey | All participants who reported what they used to prevent pregnancy in the prior 3 months at Baseline or at 3 months or at 6 months | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
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| Secondary | Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a) | The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome. | Intervention participants who used app | Posted | Mean | Standard Deviation | Scores on a scale | Immediate pre-app (Baseline), Immediate post-app (< 1 hour) |
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| Secondary | Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b) | The single yes/no item was self-administered in an online survey | All participants who completed the item at Post-visit Follow-up (48 hours post-visit) | Posted | Count of Participants | Participants | Post-visit Follow-up (48 hours after Baseline) |
|
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| Secondary | Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a) | Recorded via self-administered online survey | All participants who answered the appropriate items at Post-visit Follow-up | Posted | Count of Participants | Participants | Post-visit Follow-up |
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| Secondary | Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1) | Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Providers seeing patients for care in Health-E You Intervention Clinics | Posted | Count of Participants | Participants | Post-study completion |
|
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| Secondary | Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2) | Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Clinical providers in Health-E You Intervention Clinics | Posted | Count of Participants | Participants | Post-study completion |
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| Secondary | Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3) | Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Clinical providers in Health-E You Intervention Clinics | Posted | Count of Participants | Participants | Post-study completion |
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| Secondary | Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4) | Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees. | Clinical providers in Health-E You Intervention Clinics | Posted | Count of Participants | Participants | Post-study completion |
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| Secondary | Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Intervention group adolescents | Posted | Count of Participants | Participants | Immediate Follow-up |
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| Secondary | Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Intervention group adolescents | Posted | Count of Participants | Participants | Immediate Follow-up |
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| Secondary | Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Intervention group adolescents | Posted | Count of Participants | Participants | Immediate Follow-up |
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| Secondary | Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8) | Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree | Intervention group adolescents | Posted | Count of Participants | Participants | Immediate Follow-up |
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| 0 |
| 693 |
| 0 |
| 693 |
| 0 |
| 693 |
| EG001 | Control Arm | Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm. | 0 | 667 | 0 | 667 | 0 | 667 |
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| 3-month Follow up |
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| 6-month Follow up |
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| Superiority |
| Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months | Mixed Models Analysis | Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site | .218 | Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05 | Slope | 0.82 | 2-Sided | 95 | -0.48 | 2.11 | Superiority | Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline |
| Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months | Mixed Models Analysis | Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site | 0.008 | Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05 | Slope | 1.58 | 2-Sided | 95 | 0.38 | 2.77 | Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline | Superiority |
| 3-month Follow up |
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| 6-month Follow up |
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| Superiority |
| Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months | Mixed Models Analysis | Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site | 0.042 | Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p<.05 | Odds Ratio (OR) | 3.29 | 2-Sided | 95 | 1.04 | 10.36 | Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline | Superiority |
| Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months | Mixed Models Analysis | Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site | 0.005 | Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p<.05 | Odds Ratio (OR) | 5.54 | 2-Sided | 95 | 1.7 | 18.06 | Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline | Superiority |
| Post-App Knowledge Scale |
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