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Global health
Protocol
WHISPER or SHOUT study: protocol of a cluster-randomised controlled trial assessing mHealth sexual reproductive health and nutrition interventions among female sex workers in Mombasa, Kenya
  1. Frances H Ampt1,2,
  2. Collins Mudogo3,
  3. Peter Gichangi3,4,5,
  4. Megan S C Lim1,2,
  5. Griffins Manguro3,
  6. Matthew Chersich6,
  7. Walter Jaoko4,
  8. Marleen Temmerman3,5,7,
  9. Marilyn Laini3,
  10. Liz Comrie-Thomson1,
  11. Mark Stoové1,
  12. Paul A Agius1,2,8,
  13. Margaret Hellard1,
  14. Kelly L’Engle9,
  15. Stanley Luchters1,2,5
  1. 1 Burnet Institute, Melbourne, Australia
  2. 2 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
  3. 3 International Centre for Reproductive Health (ICRH), Mombasa, Kenya
  4. 4 University of Nairobi, Mombasa, Kenya
  5. 5 Department of Obstetrics and Gynaecology, International Centre for Reproductive Health (ICRH), Ghent University, Ghent, Belgium
  6. 6 Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa
  7. 7 Aga Khan University, Nairobi, Kenya
  8. 8 Judith Lumley Centre, La Trobe University, Melbourne, Australia
  9. 9 University of San Francisco, San Francisco, California, USA
  1. Correspondence to Professor Stanley Luchters; stanley.luchters{at}burnet.edu.au

Abstract

Introduction New interventions are required to reduce unintended pregnancies among female sex workers (FSWs) in low- and middle-income countries and to improve their nutritional health. Given sex workers’ high mobile phone usage, repeated exposure to short messaging service (SMS) messages could address individual and interpersonal barriers to contraceptive uptake and better nutrition.

Methods In this two-arm cluster randomised trial, each arm constitutes an equal-attention control group for the other. SMS messages were developed systematically, participatory and theory-driven and cover either sexual and reproductive health (WHISPER) or nutrition (SHOUT). Messages are sent to participants 2–3 times/week for 12 months and include fact-based and motivational content as well as role model stories. Participants can send reply texts to obtain additional information. Sex work venues (clusters) in Mombasa, Kenya, were randomly sampled with a probability proportionate to venue size. Up to 10 women were recruited from each venue to enrol 860 women. FSWs aged 16–35 years, who owned a mobile phone and were not pregnant at enrolment were eligible. Structured questionnaires, pregnancy tests, HIV and syphilis rapid tests and full blood counts were performed at enrolment, with subsequent visits at 6 and 12 months.

Analysis The primary outcomes of WHISPER and SHOUT are unintended pregnancy incidence and prevalence of anaemia at 12 months, respectively. Each will be compared between study groups using discrete-time survival analysis.

Potential limitations Contamination may occur if participants discuss their intervention with those in the other trial arm. This is mitigated by cluster recruitment and only sampling a small proportion of sex work venues from the sampling frame.

Conclusions The design allows for the simultaneous testing of two independent mHealth interventions for which messaging frequency and study procedures are identical. This trial may guide future mHealth initiatives and provide methodological insights into use of reciprocal control groups.

Trial registration number ACTRN12616000852459; Pre-results.

  • Community Gynaecology
  • Anaemia
  • International Health Services
  • Public Health

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/

https://doi.org/10.1136/bmjopen-2017-017388

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    Footnotes

    • Contributors The following authors were investigators on the trial from the outset: FHA, CM, PG, MSCL, MC, WJ, MT, ML, LC-T, MS, PAA, MH, KL SL. GM more recently joined the trial site in Kenya, leading work in that site. The paper draws from the trial protocol, which was written collectively, under the leadership of the Principal Investigator SL. The final version of the paper was read and approved by all authors.

    • Funding Australia’s National Health and Medical Research Council (NHMRC) provided funding for Project Grant GNT 1087006, Career Development Fellowships for SL and MS, and a Postgraduate Scholarship for FHA. The sponsor did not have any contribution to the study design, data collection, management, analysis or interpretation.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Monash University (MUHREC) in Australia and Kenyatta National Hospital Ethics and research committee in Kenya.

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

    • Data sharing statement Data presented in this paper are available from the corresponding author on request.