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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
  1. Kathleen P. Tebb1,
  2. Felicia Rodriguez1,
  3. Lance M. Pollack2,
  4. Sang Leng Trieu3,
  5. Loris Hwang4,
  6. Maryjane Puffer3,
  7. Sally Adams1,
  8. Elizabeth M. Ozer1,
  9. Claire D. Brindis5
  1. 1 Department of Pediatrics, University of California, San Francisco, California, USA
  2. 2 Center for AIDS Prevention Studies, University of California, San Francisco, California, USA
  3. 3 The Los Angeles Trust for Children’s Health, Los Angeles, California, USA
  4. 4 Department of Pediatrics, University of California, Los Angeles, California, USA
  5. 5 Institute for Health Policy Studies, University of California, San Francisco, California, USA
  1. Correspondence to Dr. Kathleen P. Tebb; kathleen.tebb{at}ucsf.edu

Abstract

Introduction Teen 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 analysis This 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 dissemination Ethics 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 number NCT02847858.

  • computer-based intervention
  • mobile health
  • disparities
  • adolescent health
  • contraception
  • latina

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors KPT 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. LP, FR, CB, LH, SLT, MP, SA and EO provided input on the study design and reviewed and edited the manuscript. LH, FR, SLT and MP also provided input on the development of the app and supported pilot testing efforts that served as the foundation for this study. LP provided statistical/analytical support including, but not limited to, sample size estimates and power analyses.

  • Funding This study is funded by the Patient-Centered Outcomes Research Institute (PCORI) contract no AD‐1502‐27481 (https://www.pcori.org/). 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.

  • Competing interests None declared.

  • Ethics approval University of California, San Francisco Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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