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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

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posted on 2023-04-26, 06:53 authored by Frances H Ampt, Collins Mudogo, Peter Gichangi, Megan SC Lim, Griffins Manguro, Matthew Chersich, Walter Jaoko, Marleen Temmerman, Marilyn Laini, Liz Comrie-Thomson, Mark StooveMark Stoove, Paul A Agius, Margaret Hellard, Kelly L’Engle, Stanley Luchters

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.

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.

History

Publication Date

2017-08-18

Journal

BMJ Open

Volume

7

Issue

8

Article Number

e017388

Pagination

10p. (p. 1-10)

Publisher

BMJ Publishing Group

ISSN

2044-6055

Rights Statement

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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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