@article{32853116572a4282b1d47a8d912a9b7e,
title = "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",
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.",
keywords = "Anaemia, Community Gynaecology, International Health Services, Public Health",
author = "Ampt, {Frances H.} and Collins Mudogo and Peter Gichangi and Lim, {Megan S.C.} and Griffins Manguro and Matthew Chersich and Walter Jaoko and Marleen Temmerman and Marilyn Laini and Liz Comrie-Thomson and Mark Stoov{\'e} and Agius, {Paul A.} and Margaret Hellard and Kelly L'Engle and Stanley Luchters",
note = "Funding Information: The authors gratefully acknowledge the contribution to this work of funding from the Victorian Operational Infrastructure Support Programme received by the Burnet Institute. 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. Funding Information: Funding Australia{\textquoteright}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. Funding Information: 1Burnet Institute, Melbourne, Australia 2Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia 3International Centre for Reproductive Health (ICRH), Mombasa, Kenya 4University of Nairobi, Mombasa, Kenya 5Department of Obstetrics and Gynaecology, International Centre for Reproductive Health (ICRH), Ghent University, Ghent, Belgium 6Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa 7Aga Khan University, Nairobi, Kenya 8Judith Lumley Centre, La Trobe University, Melbourne, Australia 9University of San Francisco, San Francisco, California, USA Acknowledgements The authors gratefully acknowledge the contribution to this work of funding from the Victorian Operational Infrastructure Support Programme received by the Burnet Institute. Publisher Copyright: {\textcopyright} 2017 Article author(s). All rights reserved.",
year = "2017",
month = aug,
day = "1",
doi = "10.1136/bmjopen-2017-017388",
language = "English",
volume = "7",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "8",
}
