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Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02847858
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kathleen Tebb, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Unprotected Sex Unsafe Sex Behavioral: Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Health-E You App Participants Behavioral: Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents
School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics).

No Intervention: Control Group



Primary Outcome Measures :
  1. Contraception Use Self-efficacy Scale Score (Aim 1b) [ Time Frame: Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline) ]
    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)

  2. Contraception Use Self-efficacy Scale Score (Aim 1c) [ Time Frame: Baseline, 3 months, 6 months ]
    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

  3. Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) [ Time Frame: Baseline, 3 months, 6 months ]
    Recorded via self-administered online survey


Secondary Outcome Measures :
  1. Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a) [ Time Frame: Immediate pre-app (Baseline), Immediate post-app (< 1 hour) ]
    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.

  2. Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b) [ Time Frame: Post-visit Follow-up (48 hours after Baseline) ]
    The single yes/no item was self-administered in an online survey

  3. Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a) [ Time Frame: Post-visit Follow-up ]
    Recorded via self-administered online survey

  4. 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) [ Time Frame: Post-study completion ]
    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.

  5. Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2) [ Time Frame: Post-study completion ]
    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.

  6. 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) [ Time Frame: Post-study completion ]
    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.

  7. Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4) [ Time Frame: Post-study completion ]
    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.

  8. Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5) [ Time Frame: Immediate Follow-up ]
    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

  9. Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6) [ Time Frame: Immediate Follow-up ]
    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

  10. Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7) [ Time Frame: Immediate Follow-up ]
    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

  11. Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8) [ Time Frame: Immediate Follow-up ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847858


Locations
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United States, California
Belmont Wellness Center
Los Angeles, California, United States
Carson Wellness Center
Los Angeles, California, United States
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kathleen Tebb, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Kathleen Tebb, University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathleen Tebb, Prinicipal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02847858    
Other Study ID Numbers: AD-1502-27481
First Posted: July 28, 2016    Key Record Dates
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by Kathleen Tebb, University of California, San Francisco:
unsafe sex
unprotected sex
adolescents
Latinas
Hispanic
mobile health applications
unintended pregnancy
teen pregnancy prevention
school-based health centers