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Global health
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Health Outcomes, Pathogenesis and Epidemiology of Severe Acute Malnutrition (HOPE-SAM): rationale and methods of a longitudinal observational study
  1. Mutsa Bwakura-Dangarembizi1,
  2. Beatrice Amadi2,
  3. Claire D Bourke3,
  4. Ruairi C Robertson3,
  5. Benjamin Mwapenya4,
  6. Kanta Chandwe2,
  7. Chanda Kapoma2,
  8. Kapula Chifunda2,
  9. Florence Majo4,
  10. Deophine Ngosa2,
  11. Pamela Chakara4,
  12. Nivea Chulu2,
  13. Faithfull Masimba4,
  14. Idah Mapurisa4,
  15. Ellen Besa2,
  16. Kuda Mutasa4,
  17. Simutanyi Mwakamui2,
  18. Thompson Runodamoto4,
  19. Jean H Humphrey4,
  20. Robert Ntozini4,
  21. Jonathan C K Wells5,
  22. Amee R Manges6,
  23. Jonathan R Swann7,
  24. A Sarah Walker8,
  25. Kusum J Nathoo1,
  26. Paul Kelly2,3,
  27. Andrew J Prendergast3,4
  28. the HOPE-SAM study team
    1. 1 Department of Paediatrics and Child Health, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe
    2. 2 Tropical Gastroenterology and Nutrition Group, University of Zambia, Lusaka, Zambia
    3. 3 Blizard Institute, Queen Mary University of London, London, UK
    4. 4 Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe
    5. 5 UCL Great Ormond Street Institute of Child Health, London, UK
    6. 6 University of British Columbia, Vancouver, British Columbia, Canada
    7. 7 Imperial College London, London, UK
    8. 8 MRC Clinical Trials Unit at UCL, London, UK
    1. Correspondence to Dr Mutsa Bwakura-Dangarembizi; mbwakura{at}medsch.uz.ac.zw

    Abstract

    Introduction Mortality among children hospitalised for complicated severe acute malnutrition (SAM) remains high despite the implementation of WHO guidelines, particularly in settings of high HIV prevalence. Children continue to be at high risk of morbidity, mortality and relapse after discharge from hospital although long-term outcomes are not well documented. Better understanding the pathogenesis of SAM and the factors associated with poor outcomes may inform new therapeutic interventions.

    Methods and analysis The Health Outcomes, Pathogenesis and Epidemiology of Severe Acute Malnutrition (HOPE-SAM) study is a longitudinal observational cohort that aims to evaluate the short-term and long-term clinical outcomes of HIV-positive and HIV-negative children with complicated SAM, and to identify the risk factors at admission and discharge from hospital that independently predict poor outcomes. Children aged 0–59 months hospitalised for SAM are being enrolled at three tertiary hospitals in Harare, Zimbabwe and Lusaka, Zambia. Longitudinal mortality, morbidity and nutritional data are being collected at admission, discharge and for 48 weeks post discharge. Nested laboratory substudies are exploring the role of enteropathy, gut microbiota, metabolomics and cellular immune function in the pathogenesis of SAM using stool, urine and blood collected from participants and from well-nourished controls.

    Ethics and dissemination The study is approved by the local and international institutional review boards in the participating countries (the Joint Research Ethics Committee of the University of Zimbabwe, Medical Research Council of Zimbabwe and University of Zambia Biomedical Research Ethics Committee) and the study sponsor (Queen Mary University of London). Caregivers provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and to caregivers at face-to-face meetings.

    • malnutrition
    • HIV
    • Africa
    • mortality
    • microbiota
    • enteropathy

    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/.

    https://doi.org/10.1136/bmjopen-2018-023077

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      Footnotes

      • Patient consent for publication Not required.

      • Contributors Designed study: MB-D, BA, CDB, RCR, BM, KC, CK, KCh, DN, PC, NC, FM, JW, ARM, JS, ASW, KJN, PK and AJP. Sought funding: MB-D, BA, CDB, RCR, JHH, ARM, JS, ASW, KJN, PK and AJP. Undertaking study: BM, KC, CK, KCh, FM, DN, PC, NC, FM, IM, EB, KM, SM and TR. Study oversight: MB-D, BA, JHH, KJN, PK and AJP. Analysis: MB-D, BA, CDB, RCR, RN, JW, ARM, JS, ASW, KJN, PK and AJP. Wrote first draft of manuscript: MB-D, CDB, RCR and AJP. Critically revised manuscript: all.

      • Funding This work was supported by the Medical Research Council UK (MR/K012711/1), the Wellcome Trust (107634/Z/15/Z to MB-D; 206225/Z/17/Z to CDB, an award funded in partnership with the Royal Society; 206455/Z/17/Z to RCR; and 108065/Z/15/Z to AJP), and a Bio-Resource Grant from the Centre for Genomic Health within the Life Sciences Initiative at Queen Mary University of London.

      • Competing interests None declared.

      • Ethics approval Medical Research Council of Zimbabwe, University of Zambia Biomedical Research Ethics Committee, Queen Mary University of London.

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

      • Collaborators Members of the HOPE-SAM study team not listed in the author list: Harare, Zimbabwe: Virginia Sauramba, Adlight Dandadzi, Chipo Kureva, Johnson Mushonga, Eddington Mpofu, Washington Dune, Tafadzwa Chidhanguro, Sibongile Nkiwane, Sandra Rukobo, Margaret Govha, Patience Mashayanembwa, Leah Chidamba, Bernard Chasekwa, Joice Tome, Rachel Makasi, Wellington Murenjekekwa, Theodore Chidawanyika, Blessing Tsenesa, Stephen Moyo, Penias Nyamwino, Pururudzai Simango, Shepherd Seremwe, Lovemore Chingaoma and Sarudzai Kasaru. Lusaka, Zambia: Andreck Tembo, Mary Mpundu, Evelyn Nyendwa, Gwendolyn Nayame, Dalitso Tembo, Sophreen Mwaba, Esther Chilala, Lucy Macwani, Tenzeni Dumba, Miyoba Chipunza, Lydia Kazhila, Temwaninge Gondwe, Dennis Phiri, Mpala Mwanza, Kanekwa Zyambo.