Clinical trial NCT02847858: Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents
Official title: Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unprotected Sex
Unsafe Sex
Keywords: unsafe sex
unprotected sex
adolescents
Latinas
Hispanic
mobile health applications
unintended pregnancy
teen pregnancy prevention
school-based health centers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-07-28
Enrollment: 1360
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Contraception Use Self-efficacy Scale Score (Aim 1b)
timeFrame: Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)
measure: Contraception Use Self-efficacy Scale Score (Aim 1c)
timeFrame: Baseline, 3 months, 6 months
measure: Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)
timeFrame: Immediate pre-app (Baseline), Immediate post-app (< 1 hour)
measure: Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)
timeFrame: Post-visit Follow-up (48 hours after Baseline)
measure: Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)
timeFrame: Post-visit Follow-up
measure: 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)
timeFrame: Post-study completion
measure: Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)
timeFrame: Post-study completion
measure: 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)
timeFrame: Post-study completion
measure: Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)
timeFrame: Post-study completion
measure: Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)
timeFrame: Immediate Follow-up
measure: Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)
timeFrame: Immediate Follow-up
measure: Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)
timeFrame: Immediate Follow-up
measure: Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)
timeFrame: Immediate Follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Belmont Wellness Center
state: California
city: Los Angeles
country: United States
facility: Carson Wellness Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathleen Tebb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.