Study Protocol for the Cluster Randomized Control Trial: Assessing

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Study Protocol for the Cluster Randomized Control Trial: Assessing the Effectiveness of A Patient-Centered Computer-Based Clinic Intervention Health-E You/ Salud iTu to Reduce Health Disparities in Unintended Pregnancies Among Hispanic Adolescents

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Manuscript ID Article Type:

bmjopen-2017-018201 Protocol 16-Jun-2017

Complete List of Authors:

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Date Submitted by the Author:

BMJ Open

Primary Subject Heading:

Sexual health

Patient-centred medicine

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Keywords:

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Secondary Subject Heading:

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Tebb , Kathleen P ; University of California San Francisco, Rodriguez, Felicia; University of California, San Francisco Pollack, Lance ; University of California San Francisco Trieu , Sang ; The L.A. Trust for Children's Health Hwang, Loris; University of California, Los Angeles Puffer, Maryjane; The L.A. Trust for Children's Health Adams , Sally ; University of California, San Francisco Ozer, Elizabeth; University of California, Department of Pediatrics Brindis, Claire; UCSF

Computer-based Intervention, Mobile Health, Disparities, adolescent health, contraception, Latina

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Study Protocol for the Cluster Randomized Control Trial: Assessing the Effectiveness of Reducing Health Disparities in Unintended Pregnancies Among Hispanic Adolescents Using Patient-Centered Computer-Based Clinic Intervention Health-E You/ Salud iTu

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Authors: Kathleen P. Tebb PhD, Felicia Rodriguez MA, Lance Pollack PhD, Sang Leng Trieu DrPh, Loris Hwang MS, MD, Maryjane Puffer MPA, Sally Adams PhD, Elizabeth Ozer PhD, and Claire D. Brindis DrPH

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Health-E You Study Protocol For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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ABSTRACT Introduction: Teen pregnancy rates in the United States remain higher than any other industrialized nation and pregnancies among Hispanic adolescents remain disproportionately high. Computer-based interventions, especially those used in conjunction with a clinical encounter, represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings show that the Health-E You computer application (app) is feasible to implement, acceptable to Latina adolescents and provides a promising approach for improving sexual health knowledge and contraceptive use when used in conjunction with a health care visit. The purpose of this manuscript is to describe the patient-centered approaches used both in developing the Health-E You app and in designing the research methods used to evaluate its effectiveness.

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Methods and Analysis: This purpose of this study is to assess the effectiveness of the Health-E You app in improving sexual health knowledge and contraceptive use among Latina adolescent girls. This study uses a cluster randomized control trial. A total of 18 school-based health centers from the Los Angeles Unified School District were randomly assigned, at equal chance, to either the intervention (Health-E You app) or control group. Analyses will examine differences between the control and intervention group’s knowledge of and attitudes towards using evidence-based contraceptives; receipt of effective contraception at the clinic visit; and self-reported use of contraception at 3 and 6 month follow-ups. The study began enrolling participants in August 2016 and a total of 1404 participants will be enrolled in the study by March 2018.

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Ethics and Dissemination: Ethics approval was obtained through the UCSF Institutional Review Board. Results of this trial will be submitted for publication in peer-reviewed journals. This study is registered with the United States National Institutes of Health. Trial ID: NCT02847858

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Strengths and Limitation of this study: • • • • •

The integration of technology to support adolescent girls’ selection of contraception. Improves the delivery of patient-centered care. Reduce disparities of contraceptive knowledge and use. Rigorous research design that engages stakeholders at all levels. The study is limited to female sexually active Latina adolescents.

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1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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INTRODUCTION Over the past two decades, teen pregnancy rates in the United States have declined dramatically.1 Nonetheless, U.S. rates remain higher than any other industrialized nation2 and pregnancies among Hispanic adolescents remain disproportionately high.3 By 12th grade, 68% of Latinasi report having had sex and 22% report having had four or more sexual partners.4 Before the age of 20, roughly 1 in 3 Latina teens have been pregnant at least once—this is one and a half times the national average and further exemplifies the significant disparities experienced by Hispanic adolescents.5 Most of these pregnancies are unintended and preventable. However, Hispanic adolescents are less likely to use contraception during sex than non-Hispanics.6,7,8 When contraception is used, condoms are most common, but often they are used inconsistently9,10 or incorrectly.11 Births to teen mothers place both young mothers and their children at a greater risk for poorer educational, economic, health and social outcomes. Given the disparities in teen pregnancies among Hispanic adolescents, this population faces a disproportionate burden of these adverse consequences.12

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Several factors contribute to unintended pregnancies among Hispanic adolescents. They tend to have less knowledge about reproductive health and contraceptives than their White peers.13,14 This group also tends to overestimate potential side effects associated with contraceptives such as weight gain, bleeding, and method reversibility.15 Many youth, especially Hispanic adolescents, hold ambivalent and conflicting attitudes about contraception, which contribute to the non or inconsistent use of effective contraception.16 For example, there is a cultural expectation for Hispanic adolescent girls to delay sex until marriage, thus, actively seeking contraceptive services represents an individual’s volition to have sex.17,18 These attitudes further contribute to fear and embarrassment in accessing and utilizing contraceptive services. Hispanic women, especially those born outside the United States, utilize reproductive health services less frequently than any other racial/ethnic group.19,20 When they do seek care, many are uncomfortable discussing sexual health topics with clinicians and fear that their health information will not be kept confidential.9 It is particularly important that information and services be provided confidentially so that Hispanics, as well as other adolescent groups, do not forgo reproductive health services.10

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The process of selecting contraception is also a barrier. The number and types of methods can be overwhelming and confusing. Most adolescents, and Hispanic youth in particular, are not aware of the relatively new non-coitally dependent, longer-acting, reversible contraception (LARC) methods,21 which include intrauterine devices (IUDs) and arm implants. LARCs are now recommended for use among adolescents22 and should be routinely included among the i

This paper uses the term Hispanic or Latina interchangeably to refer to individuals residing in the United States who are of Mexican, Central American, South American, or Caribbean origin or ancestry.


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contraceptive options for adolescents.23 LARCs are particularly advantageous for adolescents because they are safe and effective (>99% efficacy),24 do not require daily adherence or frequent visits for refills, and are highly cost-effective.17,18 LARCs are also undetectable to others, thus precluding inadvertent disclosure. While research is limited, one study found only 21% of sexually active adolescents have heard of IUDs, 71% feel uncertain about IUD safety, and 58% feel uncertain about IUD efficacy.25,26,27 These barriers are further exacerbated for youth who are English language learners and/or who have limited health literacy.9,21,28 In addition to patient-related barriers, clinician-related barriers are common in that clinicians do not consistently include LARCs as part of their comprehensive contraceptive counseling and care.29,30 In recent years, under the Affordable Care Act (ACA), health plans have been required to include contraceptive services without cost sharing, which removes an important barrier for low-income adolescents.31 Yet, there is considerable uncertainty regarding the fate of this and other provisions under and related to the ACA. Clinicians often lack the skills, comfort, or time to provide the comprehensive education necessary for patient-centered choice.30,32,33,34,35,36 Traditional health education approaches are suboptimal, clinical guidelines are followed inconsistently, and there are significant gaps in sexual health information and services for Hispanic adolescents.33 Clinicians who provide family planning services also face language or cultural barriers, time constraints, and misconceptions about the risk of infection, expulsion, and infertility with LARCs.33,34,35,37,38 As a result, despite recommendations and clinical guidelines, many clinicians still do not offer LARCs to their teen patients.27,33-35

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Computer-based interventions, including mobile health technologies and applications (apps), have an opportunity to improve access and provision of comprehensive reproductive health services, especially when integrated into the health care delivery system. An app can individualize the educational experience and improve the quality of reproductive health services. For instance, computer-based sexual health risk assessments have improved teen’s disclosure of sexual health risk behaviors.35,39 Computer-based systems can address psychological aspects of behavior in ways that teens perceive to be less judgmental than advice from a health educator or clinician. Interactive patient- centered systems can respond to a patient’s unique needs and risk profiles, tailor health information and messaging to meet diverse racial / ethnic backgrounds, and “activate” patients to ask about/advocate for services they may need. The apps can be readily translated into different languages with culturally appropriate phrasing and imagery.40 In addition, previous research indicates adolescents are interested in talking about sexual health issues with their clinician, but often do not initiate such conversations.41 An interactive app that addresses a patient’s individual responses and generates a summary message from the patient to the clinician could trigger this important conversation. Patient request for LARCs may also help clinicians, who are hesitant to provide LARCs, facilitate the provision of LARCs.

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While computer-based health interventions have been highly acceptable among Hispanic adult populations and those with low-literacy,42,43 there is little evidence regarding computer-based sexual health interventions for Hispanic adolescents.44 Most adolescents now have internet access via home, school and/or smart phones and almost all (92%) report going online at least daily and this usage is growing.45 Approximately 71% of Hispanic teens have a smart phone. In addition, Hispanic teens use the internet more frequently than white teens. 45 Computers, tablets and on-line technologies are also an especially attractive medium for delivering health information for adolescents and young adults.46,47,48 While mobile health apps are becoming more common, so far none have been focused on supporting Hispanic adolescents’ decisionmaking process to select the appropriate contraceptive option and to help eliminate clinician barriers to providing evidence-based contraceptive services.

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The purpose of this manuscript is to describe the development of the Health-E You/Salud iTu app as well as the study methods, procedures, analysis and dissemination plans for a cluster randomized clinical trial. In all phases of this project, from development to evaluation, we incorporated a patient-centered approach with guidance from both youth and community advisory boards and input from clinicians and clinic staff.49 Health-E You/Salud iTu is a novel, interactive, patient-centered, mobile clinical contraceptive health application (app), designed to accompany a health care visit in a SBHC. It is grounded in Social Cognitive Theory (SCT)50,51 a theoretical framework of behavior change and incorporates interactive technology to provide customized educational experience and support an individual’s decision-making process in selecting an effective method of contraception that is based on their own unique needs, preferences, and experiences. In this way, it aims to enhance youths’ self-efficacy to discuss and use effective contraception. SCT posits that personal efficacy is a strong predictor of behavior.50,51 Based on the information and preferences elicited from the user, Health-E You/Salud iTu provides a convenient, private, and self-paced learning environment that encourages learning through games and user-driven requests for information. The app also features You-Tube style videos of Latina youth and health care providers to support user’s decision-making process and further enhance motivation and self-efficacy to use effective contraception. Youth are supported to think about their personal timeline and goals for whether or when they would like to have a baby. Algorithms are used to support contraception selection by taking into account the individual’s preferences for and barriers to contraception (e.g., privacy needs, effects on menstrual cycles and other side effects, adherence ability, past experience and method satisfaction, etc.).

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Health-E You/ Salud iTu was developed in close partnership with Latina youth and health care providers to ensure its salience to this specific population. The app was then pilot tested with 120 patients in three school-based health centers (SBHCs) in California52 during a five month period. These SBHCs were all located on high school campuses and provide a range of 4 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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confidential health services including contraception. It was designed to be integrated into the health care delivery system of SBHCs and to serve as a “clinician extender” by providing sexual health information and customized messaging in order to enhance client and clinician readiness and thus, improve the efficiency and effectiveness of the health visit.53 Findings from the pilot study indicate that the app is feasible to implement, acceptable to both Latina adolescents and clinic staff, and provides a promising approach for improving sexual health knowledge and contraceptive use when used in conjunction with a health care visit.52 Pilot tests also gathered additional feedback to inform subsequent improvements in the app to improve the user experience. For example, partners filmed short video clips about contraceptive methods with age-appropriate youth, the app was updated to include photos that are more representative of the targeted demographic, and the design team incorporated youth-friendly colors and graphics into the look and feel of the app.

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OBJECTIVES

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The objective of this clinical trial is to evaluate the effectiveness of Health-E You/ Salud iTu on its ability to reduce disparities in contraceptive knowledge and improve access to, and utilization of, effective contraceptives among Latina adolescents. The specific aims are as follows: Aim 1: Examine the extent to which the Health-E You contraceptive app supports adolescents in making decisions about an effective method of contraception. Specifically, we will examine its effectiveness to: a) increase adolescents’ knowledge of sexual health and contraceptive options; b) increase the proportion of adolescents who report being prepared to select an effective form of contraception; and c) increase adolescents’ self-efficacy to select and use an effective contraceptive method. Aim 2: Evaluate the efficacy of the Health-E You contraceptive app on its ability to improve the effectiveness and efficiency of the clinical encounter. Specifically, we will evaluate its effectiveness to: a) improve adolescents’ and clinicians’ perception of the quality and efficiency of the visit; and b) increase the proportion of visits where adolescents and clinicians discussed contraception Aim 3: Evaluate the effectiveness of the Health-E You contraceptive app to reduce the incidence of unprotected sexual intercourse (and associated unintended pregnancies) among Latina adolescent girls. Specifically, we will evaluate its effectiveness to: a) increase the proportion of sexually active adolescents who receive an effective contraceptive at their clinic visit; and b) increase the proportion of sexually active adolescents who adhere to an effective contraceptive method over time -- at three and six months after their clinic visit.

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Aim 4: Disseminate the Health-E You intervention: If proven effective, we will work with our collaborative partners and stakeholders to disseminate findings and the app to control clinics and through community-based, state, and national associations. METHODS AND ANALYSIS Study Design A total of 18 SBHCs in the Los Angeles Unified School District (LAUSD) were randomly assigned to either the intervention (Health-E You app) or control group (standard of care, no app). LAUSD is the second largest school district in the United States. LAUSD is an ideal setting for a cluster randomized control trial because of the large number of SBHCS. In addition, these SBHCs serve a large proportion of Latina adolescents and have high rates of unintended pregnancies and STIs (reflecting unprotected sex).54,55 In addition, these sites expressed a willingness and commitment to participating in a rigorous, randomized control trial.

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Recruitment and Procedures Participant recruitment began in August 2016 and will continue through March 2018. Prior to implementing the app, providers and staff at each of the participating SBHCs participated in a training about the aims of the study, study procedures including how to integrate the iPad in the each unique clinic workflow. All adolescent girls between the ages of 14-18 years who come to any of the participating SBHCs, are invited to use an iPad. They are given disposable earbuds to maintain privacy while using the iPad. The iPad app first asks the user to select their language preference (English or Spanish), informs them of their confidentiality rights and protections and obtains voluntary consent. It then collects basic demographic and health history information that is part of the routine adolescent health care visit. The computer then identifies teens who are eligible for the study. Eligible adolescents who agree to participate then complete a computerized questionnaire to assess their knowledge of contraception and their self-efficacy to obtain sexual health care.

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Participants in the intervention clinics continue to the Health-E You contraceptive intervention app before they see the clinician, whereas participants in the control clinics proceed directly to their routine clinician visit. Users are asked a series of questions (e.g., medical history and lifestyle considerations) to assess possible medical contraindication and then determine which method(s) may be “top choice(s)” for them. Where applicable, the app encourages patients to preferentially consider the more effective methods by offering user-selected video vignettes that correspond with those methods. However, the user always has the freedom to view and learn about any of the contraception options regardless of the “top choice(s)” recommended based on their interactive responses.

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When users are finished with that process, they are then asked to share their choice and some basic additional health information with their clinician. The app generates a brief summary of information based on their interaction with the app that includes the contraceptive methods that the app recommended as well as the contraceptive methods they are most interested in obtaining or learning more about from the clinician. The adolescent has an opportunity to review this information and then send it to the clinic’s wireless printer. This information is then printed out for the clinician prior to the face-to face portion of the visit, enabling the clinician to provide patient-centered care.56 The app concludes with post-app knowledge assessment questions and a reminder that the user will receive a follow-up survey within 48 hours after the visit and two subsequent surveys at 3 and 6 months. The patient then proceeds to the face-toface encounter with the clinician.

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Inclusion Criteria Adolescents are eligible to participate in the study if they are: Female Aged 14-18 years of age Hispanic/Latina English or Spanish-speaking Sexually active (have had sexual intercourse) Not currently pregnant (or not sure that they are pregnant) Not currently using a LARC method of contraception (e.g. intrauterine device or arm implant)

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• • • • • • •

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Choice of Comparators The standard of care (control group) is typically the implementation of a static adolescent health risk questionnaire on an iPad and clinician-initiated contraceptive services. This standard of care will be compared to the intervention in which adolescents will use the Health-E You app. This choice of comparators allows our analyses to isolate the effect of the app and determine whether the app increases adolescent sexual health and contraceptive knowledge, self-efficacy in selecting an effective method, satisfaction with the visit, and adherence to an effective contraceptive method over time.

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Follow-up Surveys (post-visit; 3 and 6 months) We will compare differences between the intervention and control group prior to the intervention, within 48 hours of the visit, and at 3 and 6-month follow-up periods. These follow-up time points were selected for a number of reasons. This time frame was selected because oral contraceptives are the most commonly used non-barrier contraceptive and rates of discontinuation are high within the initial 3-month period.56 In addition, unprotected sex, including use of the withdrawal method, is very high among adolescents57 placing them at high risk for STIs. Furthermore, research has


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demonstrated that adolescent girls’ self-reported contraceptive use and sexual behaviors are reliable at 3 and 6month follow-up assessment intervals.58 Follow-up procedures are designed to maximize participant retention over time and minimize bias due to attrition. Participants are informed prior to participation that they will be asked to complete three follow-up surveys (post visit and at 3 and 6 months post visit). Eligible participants are rewarded for their participation. The reward structure is as follows: • • • •

Study participants receive $10 for agreeing to participate in the research study and completing the baseline information and immediate follow-up survey; $20 for completing the three month follow-up assessment, $20 for completing the six month follow-up, and a $20 bonus for completing all surveys. For a total of $70 if all surveys are completed.

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After providing consent, adolescents are asked to select their preference for receiving the follow-up survey via a link sent to their e-mail account or a text message to their cell phone. Approximately 5 days before the 3 or 6 month survey is due, participants receive a reminder (via the youth’s preferred reminder method(s): text and/or e-mail. During the consent process, we also gather the names and contact information for two close friends and/or family members we can contact in the event there are changes to the participant’s cell phone/e-mail and/or school. Our approach has been successfully used in prior longitudinal studies of high risk adolescents, including those in pregnancy prevention interventions.59,60,61,62,63

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Sample Size Estimates and Power Analyses: In designing this study, we adhered to the criteria of the Patient Centered Outcomes Research Institute (PCORI) methodology principals pertaining to the development of research questions.64 According to our preliminary studies, approximately 80% of the eligible adolescents will agree to participate. A total sample of 1400 sexually active Latina girls aged 14-18 will be enrolled in the study (700 per treatment group, an average of 78 per clinic). Although we have instituted a graduated incentive structure in an attempt to minimize attrition, the absence of school linkages is depressing retention rates. We anticipate that ultimately we will lose approximately 40% of the sample by the 3-month follow up (840 total, 420 per treatment group) and another 10% by the 6-month follow-up (700 total, 350 per treatment group).

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Minimum detectable change if: TABLE 1. POWER ANALYSIS Outcome

% of Baseline Sample (N) 40% (560)

Control Proportion 42%

ICC=.01 Change (h) +13% (.269)

ICC=.05 Change (h) +18% (.370)

ICC=.09 Change (h) +22% (.446)

60% (840)

27%

+11% (.232)

+16% (.346)

+21% (.428)

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27%

+12% (.246)

+17% (.356)

+21% (.436)

Receive effective method at visit* Use effective method at 3 months Use effective method at 6 months

50% (700)

* Analysis is limited to participants not already using an effective contraceptive method. As shown in Table 1, assuming power = .80 and alpha = .05, the minimum detectable difference in the primary behavioral outcome at each time point between the intervention and the control condition is 11-13, 16-18 or 21-22 percentage points depending on whether the intraclass correlation (ICC) assessing the clustering effect of clinics is low, moderate, or high. Estimated prevalence of outcomes in the control condition come from preliminary data collection, and the ICC range is suggested by data from Reading et al.65 The calculated differences in proportions translate into an effect size (Cohen’s h) falling between a small (h=.20) and medium (h=.50) effect size for all three levels of ICC. Specifically regarding evaluation of the intervention condition, the minimum achievable precision for point estimates of proportions is a confidence interval width of 12 percentage points for visit data, 10 percentage points for 3 month data, and 11 percentage points for 6 month data.65

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ANALYTIC METHODS

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The following is a description of our analytic approaches to address the major research aims. Research Questions The protocol for this study is designed to address three main questions that pertain to the study aims: 1) How well does the patient-centered, interactive, individually tailored Health-E You app engage and support Latina adolescents in understanding their risk of an unintended pregnancy and in making decisions in selecting among effective contraceptive options that can reduce their risk? 2) To what extent does the app improve Latina adolescents’ and clinicians’ perception of the quality and efficiency of the visit? 3) How well does the app improve, sexually active Latina adolescents use of and adherence to effective contraceptives over time?

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Missing Data Our approach to handling missing data meets the PCORI methodology standards. Information on potential sources of bias will be collected throughout the study such as missing data and patient dropouts. Since we are using relatively brief self-administered instruments, the amount of missing data is likely to be minimal. When necessary, we will employ multiple imputations that allow models to be fit to all available data and invokes the mild assumption that the data are missing at random. Assessment of the Implementation of the Intervention: We will examine qualitative data gathered from the research assistant team's site monitoring visits to examine how the app is being implemented; identify factors that may bias or contaminate an arm; as well as implementation barriers and facilitators. We assess adolescent participants’ satisfaction with and reaction to the app and the subsequent clinical visit in the post-visit survey from responses to a short series of statements in the form of Likert-type items employing 5-point agreement response scales. We will use descriptive statistics (e.g., mean, mode, standard deviation, minimum and maximum) to analyze the ratings of the app. We will report a point estimate and 95% confidence interval for the percent of respondents who agree with each satisfaction statement. We will also examine if percent agreement varies according to key demographic variables (e.g., age, gender, race/ethnicity, language spoken, etc.) using a cross tabulation procedure and chi-square statistics.

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Assessment of Health-E You/ Salud iTu’s Effectiveness: We will assess effectiveness by looking for differences between the control and intervention group’s knowledge of and attitudes towards using evidence-based contraceptives; receipt of effective contraception at the clinic visit; self-reported use of contraception at follow-up; and changes in the proportion of contraceptive methods that the participating clinics provide. There is the potential for noncomparability between intervention and controls despite random assignment. The groups will be compared on all non-outcome measures. If substantial differences are observed, we will perform a statistical balancing approach by computing a weight for each participant equivalent to the inverse probability of having been assigned to the intervention condition, as estimated by regressing the condition on those same non-outcome measures.

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For outcomes that are assessed at more than one time point (i.e., baseline, post visit, 3 and 6 month follow-up), we will assess the effect of the intervention using generalized mixed effects models estimated by maximum likelihood. These models will include the repeated outcome measure as the response variable, as well as terms for the intercept, an indicator of treatment group (intervention vs. control), a time effect, the time by group interaction, and demographic covariates. We will fit models with random intercepts and time effects to accommodate the repeated measures gathered from each subject and to allow subject-specific changes in the 10 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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responses over time. We will fit linear mixed-effects models (normal distribution and identity link function) to continuous responses such as measured knowledge and binary mixed-effects models (binomial distribution and logit link function) to dichotomous responses such as use of effective contraception. If knowledge scores are generally high, we may re-score the scale as number of errors and employ a Poisson distribution and log link function to accommodate the positively skewed measure. Analysis of other count-based outcomes (e.g., number of vaginal intercourse partners, number of times had vaginal intercourse) will use the same approach. Our analyses will focus on the time by group interaction term that assesses differences in changes in response over time between subjects in the intervention and control groups. We will also include random effects for clinic in the mixed effects models to allow for baseline differences in responses.

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For outcomes assessed at a single time point, analyses will compare data between the intervention and control groups for the follow-up surveys, using linear regression for continuous outcomes, Poisson or negative binomial regression for counts, and logistic regression for dichotomous outcomes. Robust variance estimation will be used to adjust for clustering by clinic. Models will contain an indicator of treatment group (intervention vs. control) plus demographic covariates. All intervention by covariate two-way interactions will be tested for statistical significance. Non-significant interactions and main effects for covariates will be deleted to obtain the most parsimonious final models.

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Heterogeneity of Treatment Effects Across SBHCs A concern in any cluster randomized control trial is whether or not the treatment effect is robust across sites. However, small per site sample sizes preclude direct comparisons between sites because of a lack of statistical power. Instead, sensitivity and heterogeneity in the treatment effect due to recruitment/treatment site (SBHC) will be assessed by using a jack-knife technique in which we compute the intervention effect while leaving out one of the intervention sites. The variability of the results of these analyses will be compared to the overall treatment effect to examine how sensitive the results are to recruitment/treatment site.

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ETHICS AND DISSEMINATION

This study was approved by the Institutional Review Board (IRB) for Protection of Human Subjects of the University of California, San Francisco (IRB Approval #: 10-02730). The app will be made available to all LAUSD SBHCs that serve adolescents as part of the dissemination efforts at the final phase of this study. We will also disseminate it to SBHCs across the nation and to other clinical settings that serve Latino adolescents. The app will be made available free of charge. We will disseminate research findings indicating clinical and policy implications through traditional dissemination activities (e.g., adolescent health/ quality 11 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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improvement conferences and peer-reviewed publications). We will also work with patients and organizations to report results in a manner understandable to and appropriate for each target audience. Beyond traditional dissemination activities, we will utilize our existing professional networks to disseminate the intervention and facilitate training through professional organizations and will make training resources more widely available through online portals to major health organizations, again with specific attention so that the information is presented in a way that is understandable to each target audience.

ACKNOWLEDGEMENTS The authors wish to thank The L.A. Trust for Children’s Health for their role in facilitating this research. Special thanks also to the project’s research associates/community outreach workers, Robert Renteria and Rosario Rico; all of the participating school-based health centers including the clinic leadership, providers and staff; youth and community advisory boards; Kim Uyeda, MD, the medical director for LAUSD Student Medical Services and Community Partnerships; and the project consultant, Rebecca Dudovitz, MD, MSHS.

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FUNDING This study is funded by the Patient Centered Outcomes Research Institute (PCORI) contract number AD-1502-27481. The statements presented in this publication are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.

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COMPETING INTERESTS No competing interests.

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AUTHORS CONTRIBUTIONS

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Kathleen Tebb is the principal investigator, oversaw the design, development and pilot testing of the app, conceived this study and was the primary author of this manuscript. All co-authors: Lance Pollack, Felicia Rodriguez, Claire Brindis, Loris Hwang, Sang Leng Trieu, Maryjane Puffer, Sally Adams and Elizabeth Ozer provided input on the study design and reviewed and edited the manuscript. Loris Hwang, Felicia Rodriguez, Sang Leng Trieu, Maryjane Puffer also provided input on the development of the app and supported pilot testing efforts that served as the foundation for the current study. Lance Pollack provided statistical/analytic support including, but not limited to, sample size estimates and power analyses.


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CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic

Item No Checklist item

Title and abstract

Introduction Background and objectives Methods Trial design Participants Interventions Outcomes

Sample size

Reported on page No

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1a 1b

Identification as a randomised trial in the title Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

Title page 1

2a 2b

Scientific background and explanation of rationale Specific objectives or hypotheses

2-5 5

3a 3b 4a 4b 5

Description of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), with reasons Eligibility criteria for participants Settings and locations where the data were collected The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Any changes to trial outcomes after the trial commenced, with reasons How sample size was determined When applicable, explanation of any interim analyses and stopping guidelines

6-11 NA 7 6

Method used to generate the random allocation sequence Type of randomisation; details of any restriction (such as blocking and block size) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

6 NA

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions If done, who was blinded after assignment to interventions (for example, participants, care providers, those

6-8

6a 6b 7a 7b

Randomisation: Sequence generation Allocation concealment mechanism Implementation

10

Blinding

11a

8a 8b 9

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6-9 9 NA 8-9 NA

NA

NA Page 1

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Statistical methods Results Participant flow (a diagram is strongly recommended) Recruitment

11b 12a 12b

assessing outcomes) and how If relevant, description of the similarity of interventions Statistical methods used to compare groups for primary and secondary outcomes Methods for additional analyses, such as subgroup analyses and adjusted analyses

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NA 6-8 6-8

Ancillary analyses

17b 18

Harms

19

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, losses and exclusions after randomisation, together with reasons Dates defining the periods of recruitment and follow-up Why the trial ended or was stopped A table showing baseline demographic and clinical characteristics for each group For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

Discussion Limitations Generalisability Interpretation

20 21 22

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability (external validity, applicability) of the trial findings Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

NA NA NA

Other information Registration Protocol Funding

23 24 25

Registration number and name of trial registry Where the full trial protocol can be accessed, if available Sources of funding and other support (such as supply of drugs), role of funders

11 11 12

Baseline data Numbers analysed Outcomes and estimation

13a

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13b 14a 14b 15 16 17a

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NA NA NA NA NA NA NA NA NA NA

*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.

CONSORT 2010 checklist

Page 2


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Assessing the Effectiveness of a Patient-Centered Computer-Based Clinic Intervention Health-E You/ Salud iTu to Reduce Health Disparities in Unintended Pregnancies Among Hispanic Adolescents: Study Protocol for a Cluster Randomized Control Trial.

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Manuscript ID Article Type:

bmjopen-2017-018201.R1 Protocol 02-Oct-2017

Complete List of Authors:

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Primary Subject Heading:

Sexual health

Computer-based Intervention, Mobile Health, Disparities, adolescent health, contraception, Latina

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Tebb , Kathleen P ; University of California San Francisco, Department of Pediatrics Rodriguez, Felicia; University of California, San Francisco, Department of Pediatrics Pollack, Lance ; University of California San Francisco, Center for AIDS Prevention Studies Trieu , Sang ; The L.A. Trust for Children's Health Hwang, Loris; University of California, Los Angeles, Department of Pediatrics Puffer, Maryjane; The L.A. Trust for Children's Health Adams , Sally ; University of California, San Francisco, Department of Pediatrics Ozer, Elizabeth; University of California, Department of Pediatrics Brindis, Claire; University of California, San Francisco , Institute for Health Policy Studies


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