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

Abstract

IntroductionTeen pregnancy rates in the USA remain higher than any other industrialised nation, and pregnancies among Hispanic adolescents are disproportionately high. Computer-based interventions represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings have demonstrated that the Health-E You/Salud iTu, computer application (app) is feasible to implement, acceptable to Latina adolescents and improves sexual health knowledge and interest in selecting an effective contraceptive method when used in conjunction with a healthcare visit. The app is now ready for efficacy testing. The purpose of this manuscript is to describe patient-centred approaches used both in developing and testing the Health-E You app and to present the research methods used to evaluate its effectiveness in improving intentions to use an effective method of contraception as well as actual contraceptive use.Methods and analysisThis study is designed to assess the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, on its ability to reduce health disparities in unintended pregnancies among Latina adolescent girls. This study uses a cluster randomised control trial design in which 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 contraceptive use, receipt of contraception at the clinic visit and self-reported use of contraception at 3-month and 6-month follow-ups. The study began enrolling participants in August 2016, and a total of 1400 participants (700 per treatment group) are expected to be enrolled by March 2018.Ethics and disseminationEthics approval was obtained through the University of California, San Francisco Institutional Review Board. Results of this trial will be submitted for publication in peer-reviewed journals. This study is registered with the US National Institutes of Health.Trial registration numberNCT02847858.

Innovative Approaches to Address Social Determinants of Health Among Adolescents and Young Adults

“…In another example, the L.A. Trust partnered with researchers to develop and evaluate a mobile health application to provide patient-centered evidence-based comprehensive contraceptive information and access to reduce disparities in unintended pregnancies among Latina adolescents. 20 Other programs such as the Door and MSACH also incorporate teen pregnancy prevention efforts that are multifaceted and include educational, medical, and social/economic approaches.…”

A Mobile Health Contraception Decision Support Intervention for Latina Adolescents: Implementation Evaluation for Use in School-Based Health Centers

“…This study is part of a larger, cluster randomized control trial (CRCT) conducted at 18 school-based health centers (SBHCs) across Los Angeles County, California, to evaluate the effectiveness of Health-E You on its ability to reduce health disparities in unintended pregnancies among sexually active Latina adolescents [29]. All clinics are SBHCs that are operated and managed independently, cover a very large area of Los Angeles County, serve a large proportion of Latina students, and are centered in areas with high rates of sexual health morbidities according to the Los Angeles County Department of Public Health.…”

A Mobile Health Contraception Decision Support Intervention for Latina Adolescents: Implementation Evaluation for Use in School-Based Health Centers (Preprint)

“…This study is part of a larger, cluster randomized control trial (CRCT), being conducted in 18 SBHCs throughout Los Angeles County, California to evaluate the effectiveness of Health-E You/ Salud iTu on its ability to reduce health disparities in unintended pregnancies among sexually active Latina adolescents [26]. The app was implemented in nine of the SBHCs randomly assigned to implement the intervention.…”

“…Users are then asked to complete a series of questions to help assess which contraceptive method(s) is the "best choice" for "you". The contraceptive recommendation algorithm used in the app is based on adolescents' preferences and attitudes that could affect their choice and use of contraception as well as concerns for potential side effects (see Tebb 2017 for details about the computer algorithm) [26]. Based on the youth's responses, the app determines which method or methods may be the "top choice(s)" for an individual.…”

“…According to the study protocol [26] (developed with input from clinicians and clinic staff) clinic staff are to provide all adolescent girls who come into the clinic, for any reason, an iPad. Upon receiving the iPad, the "user" selects their language preference (English or Spanish) and the app is launched.…”