Results Summary and Professional Abstract

Results Summary

Results Summary

Download Summary Español (pdf) Audio Recording (mp3)

What was the research about?

Teen pregnancy rates in the United States have decreased overall but remain high in certain groups. In this study, the research team tested the Health-E You/Salud iTu app in school-based health centers, or SBHCs, to help Latina teens learn about birth control and choose a method that works for them.

The app included a game to help teens learn about different birth control methods. It also offered a series of questions to help teens choose a method. Teens used the app in English or Spanish on an iPad before talking with clinicians, such as doctors or nurses. The SBHC clinician received information from the app about teens’ preferred birth control method before their visit.

The research team compared teens who used the app with teens who received usual care. For usual care, teens completed an online survey about their sexual health history and birth control use.

What were the results?

Teens had more knowledge about birth control right after they used the app than before. Compared with teens who received usual care, teens who used the app felt more confident

• That they had enough information to choose a birth control method
• Talking to their clinician about birth control
• Using birth control correctly

Six months after the clinic visit, teens who used the app were more likely to use a non-barrier method of birth control, such as the pill, the patch, or an implant, than teens who received usual care. Birth control use increased 119 percent among teens who used the app and 45 percent among teens who received usual care. Also, clinicians and teens reported high app satisfaction and that the app improved the clinic visit.

The two groups didn’t differ in the number of teens that discussed birth control with clinicians or whether they received a birth control method within two days of their SBHC visit.

Who was in the study?

The study included 1,360 Latina teens ages 14–18 who were sexually active. All teens received care at one of 18 SBHCs in Los Angeles. The average age was 16.

What did the research team do?

The research team assigned SBHCs by chance either to use the app or provide usual care. The team surveyed teens before and after their SBHC visit and again within two days, and three and six months later.

Teens and healthcare staff helped design Health-E You/Salud iTu and gave input on the study.

What were the limits of the study?

All teens received care at SBHCs in one county. Results may differ for teens in other places or healthcare settings. Only half of teens completed the survey at six months, which may have affected results.

Future research could look at how the app works for teens who receive care in other places or settings.

How can people use the results?

SBHCs can use these results when considering ways to help Latina teens choose a birth control method.

Professional Abstract

Professional Abstract

Objective

To evaluate the effectiveness of a computer-based health app, Health-E You/Salud iTu, in increasing knowledge, self-efficacy, and use of effective contraception over time and improving effectiveness and efficiency of the clinical encounter

Study Design

Design Element	Description
Design	Cluster randomized controlled trial
Population	1,360 Latina adolescents ages 14–18
Interventions/ Comparators	Health-E You/Salud iTu app Usual care
Outcomes	Primary: self-efficacy in choosing a contraceptive method, receipt of a non-barrier contraceptive method after the SBHC visit, contraceptive use Secondary: contraceptive knowledge, number of teens that discussed birth control with clinicians; provider-reported and patient-reported effectiveness and efficiency of the clinical encounter
Timeframe	Up to 6-month follow-up for primary outcomes

This cluster randomized controlled trial compared the effectiveness of the Health-E You/Salud iTu app with usual care in supporting Latina adolescents making choices about birth control. Compared with other ethnic groups, Latina adolescents may have less access to health care and information that helps them choose and use contraception.

Researchers randomized 18 school-based health centers (SBHCs) to use Health-E You/Salud iTu or to provide care as usual. At SBHCs offering Health-E You/Salud iTu, adolescents used the app in English or Spanish during their visit. The app included an educational game and a series of questions to assess adolescents’ attitudes, preferences, and experiences related to choosing a contraception method, including side effects, method efficacy, and the need for privacy. The app generated a list of recommended contraceptive methods based on adolescents’ responses. The healthcare provider received information from the app about adolescents’ preferred birth control method before their visit. At SBHCs offering usual care, adolescents completed an online survey about their sexual health history and contraceptive use.

The study included 1,360 Latina adolescents ages 14–18 receiving care from 18 SBHCs in Los Angeles County who reported that they were sexually active. The average age was 16.

Researchers surveyed adolescents at baseline, immediately after using the app, within two days after their visit, and three and six months later to assess study outcomes.

Adolescents and healthcare providers helped design the app and provided input on the study.

Results

Health-E You users’ knowledge was significantly higher immediately after using the app than at baseline (odds ratio [OR]=1.62; 95% confidence interval [CI]: 1.43, 1.82; p<0.001).

Compared with adolescents receiving usual care, those who used the app reported greater increases in

• Self-efficacy from baseline to six months (OR=1.58; 95% CI: 0.38, 2.77; p=0.010)
• Contraceptive use from baseline to three months (OR=3.29; 95% CI: 1.04, 10.36; p=0.042) and six months (OR=5.54; 95% CI: 1.70, 18.06; p=0.005)

Between baseline and six months, contraceptive use increased 119% among app users and 45% among adolescents receiving usual care.

Providers and adolescents reported high satisfaction with the app and found that it improved the effectiveness and efficiency of care.

The two groups did not differ significantly in the number of adolescents that discussed birth control with clinicians or whether they received a birth control method within two days of their SBHC visit.

Limitations

All adolescents in the study received health care at SBHCs in one county. Findings may differ in other locations or settings. Only 50% of adolescents completed the survey at six months, which may have biased results.

Conclusions and Relevance

The Health-E You/Salud iTu app supported Latina adolescents in choosing a birth control method with their healthcare provider and continuing their chosen method six months later.

Future Research Needs

Future research could test Health-E You/Salud iTu in other locations or healthcare settings.

More on this Project  

2019 PCORI Annual Meeting Breakout Session

Navigating Complex Choices: Shared Decision Making across the Care Continuum
Increasingly, patients are faced with health decisions that have many options, uncertain outcomes, and benefits and harms that are valued differently by each individual. Shared decision making recognizes the importance of having patients and providers work together to select tests and treatments, though more clarity is needed on what it means and how it is implemented in day‐to‐day care. During this breakout session, panelists -- who included Kathleen Tebb, PhD -- highlighted how shared decision making includes evaluation of options based on care goals, concerns, and personal context of individuals.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

• The reviewers requested that the researchers clarify their use of the terms, unprotected sex and effective contraception, noting that the study appeared to consider these terms in relation to unintended pregnancy only, and not in relation to sexually transmitted infections (STIs). The researchers clarified in the text that their focus was on unintended pregnancy and they did not evaluate changes in either pregnancy rates or STIs. Specifically, their focus was on educating participants about contraception options and their efficacy, in particular the superior efficacy of long-acting reversible contraception as birth control. The researchers also clarified that their app did describe the advantages of barrier-based contraception in preventing STIs and encouraged participants to use both methods when possible.
• The reviewers commented on the high attrition rate, with about half of participants dropping out of the study during the six-month study period. They asked if the researchers could offer insight on why attrition was higher in the intervention arm than in the control arm. The researchers added some thoughts on attrition rates in the report’s limitations section, including students providing incorrect follow-up information when they entered the study because of immigration fears, and that the attrition rates were comparable to those of other randomized controlled trials conducted online. The researchers indicated that one reason for improved follow-up rates in the control arm was because of increased efforts of staff in one of the control clinics, while other clinics considered these efforts infeasible and too time consuming. The researchers also stated that they did not feel comfortable hypothesizing further regarding the relationship between the high attrition rate and improved contraception use.
• The reviewers commented on the researchers’ assertion that the intervention and control groups were equivalent demographically at baseline and asked if there were tests demonstrating equivalence. The researchers said the groups were comparable because of the narrow inclusion criteria for the study: all participants were teenage female Latinas who had, had sex and were not using long-acting contraceptives at the time of enrollment. However, the intervention group participants were more likely to have visited the school-based health center where they were enrolled for the study for a pregnancy-related purpose and were more likely to be sexually active within the preceding three months. The researchers indicated that they included these variables as covariates in their comparisons.

Conflict of Interest Disclosures

The Conflict of Interest Disclosures for this project will be posted here soon. 

Project Details

Principal Investigator

Kathleen P. Tebb, PhD

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

Reducing Health Disparities in Unintended Pregnancies Among Hispanic Adolescents Using a Patient-Centered Computer-Based Clinic Intervention

Board Approval Date

September 2015

Project End Date

October 2020

Organization

University of California San Francisco

Year Awarded

2015

State

California

Year Completed

2020

Project Type

Research Project

Health Conditions  

Reproductive and Perinatal Health

Contraceptive Care

Intervention Strategies

Other Health Services Interventions
Technology Interventions
Training and Education Interventions

Populations

Children -- 18 and under
Low Health Literacy/Numeracy
Low Income
Racial/Ethnic Minorities
Women

Funding Announcement

Addressing Disparities

Project Budget

$1,998,469

Study Registration Information

HSRP20162007

NCT02847858