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Unprotected SexNCT02847858

Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents

A study testing Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents in people with Unprotected Sex and Unsafe Sex, run by University of California, San Francisco at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 years, women only
Conditions the study is for
Unprotected Sex, Unsafe Sex
What is being tested?
Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,360 participants
Where
2 sitesUnited States
Study dates
Aug 2016to 31 Jan 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 14 to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Female 14-18 years of age Hispanic/Latina English or Spanish-speaker Has had sexual intercourse

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Belmont Wellness Center

    Los Angeles, California

  • Carson Wellness Center

    Los Angeles, California

Other trials in United States

About this study

Official title: Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention

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.

Read more

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.

Being tested
Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents
Keywords
unsafe sex, unprotected sex, adolescents, Latinas, Hispanic, mobile health applications, unintended pregnancy, teen pregnancy prevention, school-based health centers
Medical subject headings
Unsafe Sex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescentsBehavioural

    School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics).

Study groups in NCT02847858
Study groupRoleWhat they receive
Health-E You App ParticipantsExperimentalNot described
Receives: Behavioral: Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents
Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)

  2. 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

    Measured: Baseline, 3 months, 6 months

  3. 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

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (11)
  1. 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.

    Measured: Immediate pre-app (Baseline), Immediate post-app (< 1 hour)

  2. 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

    Measured: Post-visit Follow-up (48 hours after Baseline)

  3. 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

    Measured: Post-visit Follow-up

  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)

    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.

    Measured: Post-study completion

  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)

    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.

    Measured: Post-study completion

  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)

    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.

    Measured: Post-study completion

  7. 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.

    Measured: Post-study completion

  8. 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

    Measured: Immediate Follow-up

  9. 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

    Measured: Immediate Follow-up

  10. 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

    Measured: Immediate Follow-up

  11. 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

    Measured: Immediate Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847858
Sponsor's protocol ID
AD-1502-27481
Status last verified
Oct 2019
First submitted
29 Jun 2016
Last updated
23 Oct 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 30869649
  • 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.

    PubMed 29326184

Questions about this trial

What is this clinical trial studying?

A study testing Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents in people with Unprotected Sex and Unsafe Sex, run by University of California, San Francisco at 2 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraception Use Self-efficacy Scale Score (Aim 1b) (time frame: Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)). The study lists 3 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 NCT02847858, which also lists 2 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 23 Oct 2019.

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