Trial Outcomes & Findings for Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents (NCT NCT02847858)
NCT ID: NCT02847858
Last Updated: 2019-10-23
Results Overview
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)
COMPLETED
NA
1360 participants
Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)
2019-10-23
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
693
|
667
|
|
Overall Study
COMPLETED
|
292
|
398
|
|
Overall Study
NOT COMPLETED
|
401
|
269
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
401
|
269
|
Baseline Characteristics
Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents
Baseline characteristics by cohort
| Measure |
Health-E You Intervention Arm
n=693 Participants
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.
|
Control Arm
n=667 Participants
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.
|
Total
n=1360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
693 Participants
n=99 Participants
|
667 Participants
n=107 Participants
|
1360 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
693 Participants
n=99 Participants
|
667 Participants
n=107 Participants
|
1360 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
693 Participants
n=99 Participants
|
667 Participants
n=107 Participants
|
1360 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
623 Participants
n=99 Participants
|
614 Participants
n=107 Participants
|
1237 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
693 participants
n=99 Participants
|
667 participants
n=107 Participants
|
1360 participants
n=206 Participants
|
|
Reason for visit related to reproductive health services
Visit related to reproductive health services
|
550 Participants
n=99 Participants
|
349 Participants
n=107 Participants
|
899 Participants
n=206 Participants
|
|
Reason for visit related to reproductive health services
Visit not related to reproductive health services
|
137 Participants
n=99 Participants
|
306 Participants
n=107 Participants
|
443 Participants
n=206 Participants
|
|
Reason for visit related to reproductive health services
Missing data
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Had sex in the past 3 months
Yes had sex in past 3 months at Baseline
|
586 Participants
n=99 Participants
|
504 Participants
n=107 Participants
|
1090 Participants
n=206 Participants
|
|
Had sex in the past 3 months
No did not have sex in past 3 months at Baseline
|
107 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Had sex in the past 3 months
Missing data
|
0 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)Population: All participants for whom a self-efficacy score was recorded either at Baseline or at Post-visit Follow-up
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)
Outcome measures
| Measure |
Intervention
n=690 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
n=640 Participants
Usual care (app not offered)
|
|---|---|---|
|
Contraception Use Self-efficacy Scale Score (Aim 1b)
Pre-visit Baseline
|
23.2 Scores on a scale
Standard Deviation 6.34
|
22.45 Scores on a scale
Standard Deviation 6.72
|
|
Contraception Use Self-efficacy Scale Score (Aim 1b)
Post-visit Follow-up (48 hours post Baseline)
|
25.22 Scores on a scale
Standard Deviation 5.11
|
23.04 Scores on a scale
Standard Deviation 6.44
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: All participants for whom a self-efficacy score was recorded at Baseline or at 3 months or at 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
Outcome measures
| Measure |
Intervention
n=690 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
n=640 Participants
Usual care (app not offered)
|
|---|---|---|
|
Contraception Use Self-efficacy Scale Score (Aim 1c)
Pre-Visit Baseline
|
23.2 Score on a scale
Standard Deviation 6.34
|
22.45 Score on a scale
Standard Deviation 6.72
|
|
Contraception Use Self-efficacy Scale Score (Aim 1c)
3-month Follow up
|
25.22 Score on a scale
Standard Deviation 4.87
|
23.37 Score on a scale
Standard Deviation 6.11
|
|
Contraception Use Self-efficacy Scale Score (Aim 1c)
6-month Follow up
|
26.24 Score on a scale
Standard Deviation 4.38
|
23.44 Score on a scale
Standard Deviation 5.98
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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
Recorded via self-administered online survey
Outcome measures
| Measure |
Intervention
n=687 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
n=650 Participants
Usual care (app not offered)
|
|---|---|---|
|
Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)
Pre-visit Baseline
|
197 Participants
|
197 Participants
|
|
Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)
3-month Follow up
|
162 Participants
|
161 Participants
|
|
Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)
6-month Follow up
|
185 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: Immediate pre-app (Baseline), Immediate post-app (< 1 hour)Population: Intervention participants who used app
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.
Outcome measures
| Measure |
Intervention
n=693 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)
Pre-App Knowledge Scale
|
3.31 Scores on a scale
Standard Deviation 1.61
|
—
|
|
Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)
Post-App Knowledge Scale
|
4.94 Scores on a scale
Standard Deviation 1.74
|
—
|
SECONDARY outcome
Timeframe: Post-visit Follow-up (48 hours after Baseline)Population: All participants who completed the item at Post-visit Follow-up (48 hours post-visit)
The single yes/no item was self-administered in an online survey
Outcome measures
| Measure |
Intervention
n=320 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
n=436 Participants
Usual care (app not offered)
|
|---|---|---|
|
Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)
|
285 Participants
|
301 Participants
|
SECONDARY outcome
Timeframe: Post-visit Follow-upPopulation: All participants who answered the appropriate items at Post-visit Follow-up
Recorded via self-administered online survey
Outcome measures
| Measure |
Intervention
n=319 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
n=436 Participants
Usual care (app not offered)
|
|---|---|---|
|
Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)
|
236 Participants
|
221 Participants
|
SECONDARY outcome
Timeframe: Post-study completionPopulation: Providers seeing patients for care in Health-E You Intervention Clinics
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.
Outcome measures
| Measure |
Intervention
n=12 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
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)
Agree helps patients in decision making
|
10 Participants
|
—
|
|
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)
Neutral/disagree helps in decision making
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-study completionPopulation: Clinical providers in Health-E You Intervention Clinics
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.
Outcome measures
| Measure |
Intervention
n=12 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)
Agrees it helps clinicians
|
9 Participants
|
—
|
|
Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)
Neutral/disagrees it helps clinicians
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-study completionPopulation: Clinical providers in Health-E You Intervention Clinics
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.
Outcome measures
| Measure |
Intervention
n=12 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
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)
Agree it helps integrate reproductive care
|
6 Participants
|
—
|
|
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)
Neutral/disagrees it helps
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-study completionPopulation: Clinical providers in Health-E You Intervention Clinics
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.
Outcome measures
| Measure |
Intervention
n=12 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)
Agrees App makes clinic schedules run behind
|
0 Participants
|
—
|
|
Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)
Neutral/disagree APP makes schedules run behind
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediate Follow-upPopulation: Intervention group adolescents
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
Outcome measures
| Measure |
Intervention
n=287 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)
Agree APP helped choose method
|
198 Participants
|
—
|
|
Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)
Neutral/disagree APP helped choose method
|
89 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediate Follow-upPopulation: Intervention group adolescents
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
Outcome measures
| Measure |
Intervention
n=287 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)
Agree APP gave useful birth control information
|
250 Participants
|
—
|
|
Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)
Neutral/disagree APP gave useful information
|
37 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediate Follow-upPopulation: Intervention group adolescents
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
Outcome measures
| Measure |
Intervention
n=287 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)
Agree it helped me talk with provider
|
192 Participants
|
—
|
|
Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)
Neutral/disagree it helped me talk with provider
|
95 Participants
|
—
|
SECONDARY outcome
Timeframe: Immediate Follow-upPopulation: Intervention group adolescents
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
Outcome measures
| Measure |
Intervention
n=287 Participants
Used Health-E You app in waiting room prior to clinical visit
|
Control
Usual care (app not offered)
|
|---|---|---|
|
Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)
Agree it helped quality of visit with provider
|
200 Participants
|
—
|
|
Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)
Neutral/disagree it helped quality of visit
|
87 Participants
|
—
|
Adverse Events
Health-E You Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kathleen Tebb
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place