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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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العنوان: 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.
المؤلفون: Ampt FH; Burnet Institute, Melbourne, Australia.; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia., Mudogo C; International Centre for Reproductive Health (ICRH), Mombasa, Kenya., Gichangi P; International Centre for Reproductive Health (ICRH), Mombasa, Kenya.; University of Nairobi, Mombasa, Kenya.; Department of Obstetrics and Gynaecology, International Centre for Reproductive Health (ICRH), Ghent University, Ghent, Belgium., Lim MSC; Burnet Institute, Melbourne, Australia.; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia., Manguro G; International Centre for Reproductive Health (ICRH), Mombasa, Kenya., Chersich M; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa., Jaoko W; University of Nairobi, Mombasa, Kenya., Temmerman M; International Centre for Reproductive Health (ICRH), Mombasa, Kenya.; Department of Obstetrics and Gynaecology, International Centre for Reproductive Health (ICRH), Ghent University, Ghent, Belgium.; Aga Khan University, Nairobi, Kenya., Laini M; International Centre for Reproductive Health (ICRH), Mombasa, Kenya., Comrie-Thomson L; Burnet Institute, Melbourne, Australia., Stoové M; Burnet Institute, Melbourne, Australia., Agius PA; Burnet Institute, Melbourne, Australia.; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.; Judith Lumley Centre, La Trobe University, Melbourne, Australia., Hellard M; Burnet Institute, Melbourne, Australia., L'Engle K; University of San Francisco, San Francisco, California, USA., Luchters S; Burnet Institute, Melbourne, Australia.; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.; Department of Obstetrics and Gynaecology, International Centre for Reproductive Health (ICRH), Ghent University, Ghent, Belgium.
المصدر: BMJ open [BMJ Open] 2017 Aug 18; Vol. 7 (8), pp. e017388. Date of Electronic Publication: 2017 Aug 18.
نوع المنشور: Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Pregnancy, Unplanned* , Reproductive Behavior* , Sex Work* , Sexual Health* , Text Messaging*, Anemia/*prevention & control , Telemedicine/*methods, Adolescent ; Adult ; Cell Phone ; Diet ; Feeding Behavior ; Female ; Health Education ; Humans ; Kenya ; Motivation ; Nutritional Status ; Pregnancy ; Reproductive Health ; Sex Workers ; Young Adult
مستخلص: 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.
Competing Interests: Competing interests: None declared.
(© 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.)
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فهرسة مساهمة: Keywords: Anaemia; Community Gynaecology; International Health Services; Public Health
تواريخ الأحداث: Date Created: 20170820 Date Completed: 20180509 Latest Revision: 20190202
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC5724193
DOI: 10.1136/bmjopen-2017-017388
PMID: 28821530
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2017-017388