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JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives
  1. Maria Lohan1,
  2. Áine Aventin1,
  3. Mike Clarke2,3,
  4. Rhonda M Curran1,
  5. Lisa Maguire1,
  6. Rachael Hunter4,
  7. Clíona McDowell3,
  8. Lisa McDaid5,
  9. Honor Young6,
  10. James White6,
  11. Adam Fletcher7,
  12. Rebecca French8,
  13. Christopher Bonell8,
  14. Julia V Bailey9,
  15. Liam O’Hare10
  1. 1 School of Nursing and Midwifery, Queen’s University Belfast, Belfast, UK
  2. 2 Centre for Public Health, Queen’s University Belfast, Belfast, UK
  3. 3 Northern Ireland Clinical Trials Unit, Belfast, UK
  4. 4 Research Department of Primary Care and Population Health, University College London, London, UK
  5. 5 MRC/CSO Social & Public Health Sciences Unit, University of Glasgow, Glasgow, UK
  6. 6 The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff University, Cardiff, UK
  7. 7 British Heart Foundation Cymru
  8. 8 Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, UK
  9. 9 Department of Primary Care and Population Health, University College London
  10. 10 Centre for Evidence and Social Innovation, Queen’s University Belfast, Belfast, UK
  1. Correspondence to Maria Lohan; m.lohan{at}qub.ac.uk

Abstract

Introduction Teenage pregnancy remains a worldwide health concern which is an outcome of, and contributor to, health inequalities. The need for gender-aware interventions with a focus on males in addressing teenage pregnancy has been highlighted as a global health need by WHO and identified in systematic reviews of (relationship and sexuality education (RSE)). This study aims to test the effectiveness of an interactive film-based RSE intervention, which draws explicit attention to the role of males in preventing an unintended pregnancy by reducing unprotected heterosexual teenage sex among males and females under age 16 years.

Methods and analysis A phase III cluster randomised trial with embedded process and economic evaluations. If I Were Jack encompasses a culturally sensitive interactive film, classroom materials, a teacher-trainer session and parent animations and will be delivered to replace some of the usual RSE for the target age group in schools in the intervention group. Schools in the control group will not receive the intervention and will continue with usual RSE. Participants will not be blinded to allocation. Schools are the unit of randomisation stratified per country and socioeconomic status. We aim to recruit 66 UK schools (24 in Northern Ireland; 14 in each of England, Scotland and Wales), including approximately 7900 pupils. A questionnaire will be administered at baseline and at 12–14 months postintervention. The primary outcome is reported unprotected sex, a surrogate measure associated with unintended teenage pregnancy. Secondary outcomes include knowledge, attitudes, skills and intentions relating to avoiding teenage pregnancy in addition to frequency of engagement in sexual intercourse, contraception use and diagnosis of sexually transmitted infections.

Ethics and dissemination Ethical approval was obtained from Queen’s University Belfast. Results will be published in peer-reviewed journals and disseminated to stakeholders. Funding is from the National Institute for Health Research.

Trial registration number ISRCTN99459996

  • public health
  • community child health
  • sexual medicine
  • preventive medicine

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors ML, AA, MC and LM conceived of the study and led study design. RMC and ML drafted this manuscript. All authors made substantive contributions to the development of the protocol, critically reviewed and gave final approval to the manuscript. AA is responsible for management of the trial and process evaluation supported by ML. HY, AF, LMc, JW, CB, RF, LO’H and JVB contributed to the design of study and development of trial recruitment areas and PPI involvement. HY and AF led on young people’s advisory group. CM and JW contributed to sample size calculation and statistical analysis plan. RH developed the economic evaluation. LO’H contributed to knowledge translation and dissemination plan.

  • Funding This research is funded by the National Institute for Health Research (NIHR) Public Health Research programme, grant number NIHR PHR 15/181/01. LMcD is funded by the UK Medical Research Council (MRC) and Scottish Government Chief Scientist Office (CSO) at the MRC/CSO Social & Public Health Sciences Unit, University of Glasgow (MC_UU_12017/11, SPHSU11).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests QUB holds copyright and the researchers do not benefit financially from its evaluation or use.

  • Patient consent Not required.

  • Ethics approval Ethical approval for the JACK Trial was granted by the Research Ethics Committee of the School of Nursing and Midwifery, Queen’s University Belfast in July 2017 (Ref: 11.MLohan.05.17.M6.V1).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Author note At the time of submission of this protocol (January 2018) optimisation of the intervention is underway, but no aspect of the trial has begun yet.

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