The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods
نویسندگان
- Jean H. Humphrey
- Andrew D. Jones
- Amee Manges
- Goldberg Mangwadu
- John A. Maluccio
- Mduduzi N. N. Mbuya
- Lawrence H. Moulton
- Robert Ntozini
- Andrew J. Prendergast
- Rebecca J. Stoltzfus
- James M. Tielsch
- Cynthia Chasokela
- Ancikaria Chigumira
- William Heylar
- Preston Hwena
- George Kembo
- Florence D. Majo
- Batsirai Mutasa
- Kuda Mutasa
- Philippa Rambanepasi
- Virginia Sauramba
- Naume V. Tavengwa
- Franne Van Der Keilen
- Chipo Zambezi
- Dzivaidzo Chidhanguro
- Dorcas Chigodora
- Joseph F. Chipanga
- Grace Gerema
- Tawanda Magara
- Mandava Mandava
- Tafadzwa Mavhudzi
- Clever Mazhanga
- Grace Muzaradope
- Marian T. Mwapaura
- Simon Phiri
- Alice Tengende
- Cynthia Banda
- Bernard Chasekwa
- Leah Chidamba
- Theodore Chidawanyika
- Elisha Chikwindi
- Lovemore K. Chingaona
- Courage K. Chiorera
- Adlight Dandadzi
- Margaret Govha
- Hlanai Gumbo
- Karen T. Gwanzura
- Sarudzai Kasaru
- Rachel Makasi
- Alois M. Matsika
- Diana Maunze
- Exevia Mazarura
- Eddington Mpofu
- Johnson Mushonga
- Tafadzwa E. Mushore
- Tracey Muzira
- Netsai Nembaware
- Sibongile Nkiwane
- Penias Nyamwino
- Sandra D. Rukobo
- Thompson Runodamoto
- Shepherd Seremwe
- Pururudzai Simango
- Joice Tome
- Blessing Tsenesa
- Umali Amadu
- Beauty Bangira
- Daniel Chiveza
- Priscilla Hove
- Horaiti A Jombe
- Didymus Kujenga
- Lenin Madhuyu
- Prince Mandina-Makoni
- Naume Maramba
- Betty Maregere
- Ellen Marumani
- Elisha Masakadze
- Phathisiwe Mazula
- Caroline Munyanyi
- Grace Musanhu
- Raymond C. Mushanawani
- Sibongile Mutsando
- Felicia Nazare
- Moses Nyarambi
- Wellington Nzuda
- Trylife Sigauke
- Monica Solomon
- Tendai Tavengwa
- Farisai Biri
- Misheck Chafanza
- Cloud Chaitezvi
- Tsundukani Chauke
- Collen Chidzomba
- Tawanda Dadirai
- Clemence Fundira
- Athanasios C. Gambiza
- Tatenda Godzongere
- Maria Kuona
- Tariro Mafuratidze
- Idah Mapurisa
- Tsitsi Mashedze
- Nokuthula Moyo
- Charles Musariri
- Matambudzo Mushambadope
- Tawanda R. Mutsonziwa
- Augustine Muzondo
- Rudo Mwareka
- Juleika Nyamupfukudza
- Baven Saidi
- Tambudzai Sakuhwehwe
- Gerald Sikalima
- Jenneth Tembe
- Tapiwanashe E. Chekera
- Owen Chihombe
- Muchaneta Chikombingo
- Tichaona Chirinda
- Admire Chivizhe
- Ratidzai Hove
- Rudo Kufa
- Tatenda F. Machikopa
- Wilbert Mandaza
- Liberty Mandongwe
- Farirai Manhiyo
- Emmanuel Manyaga
- Peter Mapuranga
- Farai S. Matimba
- Patience Matonhodze
- Sarah Mhuri
- Joice Mike
- Bekezela Ncube
- Walter T. S. Nderecha
- Munyaradzi Noah
- Charles Nyamadzawo
- Jonathan Penda
- Asinje Saidi
- Sarudzai Shonhayi
- Clemence Simon
- Monica Tichagwa
- Rachael Chamakono
- Annie Chauke
- Andrew F. Gatsi
- Blessing Hwena
- Hillary Jawi
- Benjamin Kaisa
- Sithembile Kamutanho
- Tapiwa Kaswa
- Paradhi Kayeruza
- Juliet Lunga
- Nomatter Magogo
- Daniel Manyeruke
- Patricia Mazani
- Fungai Mhuriyengwe
- Farisai Mlambo
- Stephen Moyo
- Tawanda Mpofu
- Mishelle Mugava
- Yvonne Mukungwa
- Fungai Muroyiwa
- Eddington Mushonga
- Selestino Nyekete
- Tendai Rinashe
- Kundai Sibanda
- Milton Chemhuru
- Jeffrey Chikunya
- Vimbai F. Chikwavaire
- Charity Chikwiriro
- Anderson Chimusoro
- Jotam Chinyama
- Gerald Gwinji
- Nokuthula Hoko-Sibanda
- Rutendo Kandawasvika
- Tendai Madzimure
- Brian Maponga
- Antonella Mapuranga
- Joana Marembo
- Luckmore Matsunge
- Simbarashe Maunga
- Mary Muchekeza
- Monica Muti
- Marvin Nyamana
- Efa Azhuda
- Urayai Bhoroma
- Ailleen Biriyadi
- Elizabeth Chafota
- Angelline Chakwizira
- Agness Chamhamiwa
- Tavengwa Champion
- Stella Chazuza
- Beauty Chikwira
- Chengeto Chingozho
- Abigail Chitabwa
- Annamary Dhurumba
- Albert Furidzirai
- Andrew Gandanga
- Chipo Gukuta
- Beauty Macheche
- Bongani Marihwi
- Barbara Masike
- Eunice Mutangandura
- Beatrice Mutodza
- Angeline Mutsindikwa
- Alice Mwale
- Rebecca Ndhlovu
- Norah Nduna
- Cathrine Nyamandi
- Elias Ruvata
- Babra Sithole
- Rofina Urayai
- Bigboy Vengesa
- Micheal Zorounye
- Memory Bamule
- Michael Bande
- Kumbirai Chahuruva
- Lilian Chidumba
- Zvisinei Chigove
- Kefas Chiguri
- Susan Chikuni
- Ruvarashe Chikwanda
- Tarisai Chimbi
- Micheal Chingozho
- Olinia Chinhamo
- Regina Chinokuramba
- Chiratidzo Chinyoka
- Xaviour Chipenzi
- Raviro Chipute
- Godfrey Chiribhani
- Mary Chitsinga
- Charles Chiwanga
- Anamaria Chiza
- Faith Chombe
- Memory Denhere
- Ephania Dhamba
- Miriam Dhamba
- Joyas Dube
- Florence Dzimbanhete
- Godfrey Dzingai
- Sikhutele Fusira
- Major Gonese
- Johnson Gota
- Kresencia Gumure
- Phinias Gwaidza
- Margret Gwangwava
- Winnet Gwara
- Melania Gwauya
- Maidei Gwiba
- Joyce Hamauswa
- Sarah Hlasera
- Eustina Hlukani
- Joseph Hotera
- Lovemore Jakwa
- Gilbert Jangara
- Micheal Janyure
- Christopher Jari
- Duvai Juru
- Tabeth Kapuma
- Paschalina Konzai
- Moly Mabhodha
- Susan Maburutse
- Chipo Macheka
- Tawanda Machigaya
- Florence Machingauta
- Eucaria Machokoto
- Evelyn Madhumba
- Learnard Madziise
- Clipps Madziva
- Mavis Madzivire
- Mistake Mafukise
- Marceline Maganga
- Senzeni Maganga
- Emmanuel Mageja
- Miriam Mahanya
- Evelyn Mahaso
- Sanelisiwe Mahleka
- Pauline Makanhiwa
- Mavis Makarudze
- Constant Makeche
- Nickson Makopa
- Ranganai Makumbe
- Mascline Mandire
- Eunice Mandiyanike
- Eunice Mangena
- Farai Mangiro
- Alice Mangwadu
- Tambudzai Mangwengwe
- Juliet Manhidza
- Farai Manhovo
- Irene Manono
- Shylet Mapako
- Evangelista Mapfumo
- Timothy Mapfumo
- Jane Mapuka
- Douglas Masama
- Getrude Masenge
- Margreth Mashasha
- Veronica Mashivire
- Moses Matunhu
- Pazvichaenda Mavhoro
- Godfrey Mawuka
- Ireen Mazango
- Netsai Mazhata
- David Mazuva
- Mary Mazuva
- Filomina Mbinda
- John Mborera
- Upenyu Mfiri
- Florence Mhandu
- Chrispen Mhike
- Tambudzai Mhike
- Artwell Mhuka
- Judith Midzi
- Siqondeni Moyo
- Michael Mpundu
- Nicholas Msekiwa Msindo
- Dominic Msindo
- Choice Mtisi
- Gladys Muchemwa
- Nyadziso Mujere
- Ellison Mukaro
- Kilvera Muketiwa
- Silvia Mungoi
- Esline Munzava
- Rosewita Muoki
- Harugumi Mupura
- Evelyn Murerwa
- Clarieta Murisi
- Letwin Muroyiwa
- Musara Muruvi
- Nelson Musemwa
- Christina Mushure
- Judith Mutero
- Philipa Mutero
- Patrick Mutumbu
- Cleopatra Mutya
- Lucia Muzanango
- Martin Muzembi
- Dorcus Muzungunye
- Valeliah Mwazha
- Thembeni Ncube
- Takunda Ndava
- Nomvuyo Ndlovu
- Pauline Nehowa
- Dorothy Ngara
- Leonard Nguruve
- Petronella Nhigo
- Samukeliso Nkiwane
- Luckson Nyanyai
- Judith Nzombe
- Evelyn Office
- Beatrice Paul
- Shambadzirai Pavari
- Sylvia Ranganai
- Stella Ratisai
- Martha Rugara
- Peter Rusere
- Joyce Sakala
- Prosper Sango
- Sibancengani Shava
- Margaret Shekede
- Cornellious Shizha
- Tedla Sibanda
- Neria Tapambwa
- John Tembo
- Netsai Tinago
- Violet Tinago
- Theresa Toindepi
- John Tovigepi
- Modesta Tuhwe
- Kundai Tumbo
- Tinashe Zaranyika
- Tongai Zaru
- Kamurayi Zimidzi
- Matilda Zindo
- Maria Zindonda
- Nyaradzai Zinhumwe
- Loveness Zishiri
- Emerly Ziyambi
- James Zvinowanda
- Ekenia Bepete
- Christine Chiwira
- Naume Chuma
- Abiegirl Fari
- Samson Gavi
- Violet Gunha
- Fadzai Hakunandava
- Constance Huku
- Given Hungwe
- Grace Maduke
- Elliot Manyewe
- Tecla Mapfumo
- Innocent Marufu
- Chenesai Mashiri
- Shellie Mazenge
- Euphrasia Mbinda
- Abigail Mhuri
- Charity Muguti
- Lucy Munemo
- Loveness Musindo
- Laina Ngada
- Dambudzo Nyembe
- Rachel Taruvinga
- Emma Tobaiwa
- Selina Banda
- Jesca Chaipa
- Patricia Chakaza
- Macdonald Chandigere
- Annie Changunduma
- Chenesai Chibi
- Otilia Chidyagwai
- Elika Chidza
- Nora Chigatse
- Lennard Chikoto
- Vongai Chingware
- Jaison Chinhamo
- Marko Chinhoro
- Answer Chiripamberi
- Esther Chitavati
- Rita Chitiga
- Nancy Chivanga
- Tracy Chivese
- Flora Chizema
- Sinikiwe Dera
- Annacolleta Dhliwayo
- Pauline Dhononga
- Ennia Dimingo
- Memory Dziyani
- Tecla Fambi
- Lylian Gambagamba
- Sikangela Gandiyari
- Charity Gomo
- Sarah Gore
- Jullin Gundani
- Rosemary Gundani
- Lazarus Gwarima
- Cathrine Gwaringa
- Samuel Gwenya
- Rebecca Hamilton
- Agnes Hlabano
- Ennie Hofisi
- Florence Hofisi
- Stanley Hungwe
- Sharai Hwacha
- Aquiiline Hwara
- Ruth Jogwe
- Atanus Kanikani
- Lydia Kuchicha
- Mitshel Kutsira
- Kumbulani Kuziyamisa
- Mercy Kuziyamisa
- Benjamin Kwangware
- Portia Lozani
- Joseph Mabuto
- Vimbai Mabuto
- Loveness Mabvurwa
- Rebecca Machacha
- Cresenzia Machaya
- Roswitha Madembo
- Susan Madya
- Sheneterai Madzingira
- Lloyd Mafa
- Fungai Mafuta
- Jane Mafuta
- Alfred Mahara
- Sarudzai Mahonye
- Admire Maisva
- Admire Makara
- Margreth Makover
- Ennie Mambongo
- Murenga Mambure
- Edith Mandizvidza
- Gladys Mangena
- Elliot Manjengwa
- Julius Manomano
- Maria Mapfumo
- Alice Mapfurire
- Letwin Maphosa
- Jester Mapundo
- Dorcas Mare
- Farai Marecha
- Selina Marecha
- Christine Mashiri
- Medina Masiya
- Thembinkosi Masuku
- Priviledge Masvimbo
- Saliwe Matambo
- Getrude Matarise
- Loveness Matinanga
- John Matizanadzo
- Margret Maunganidze
- Belinda Mawere
- Chipiwa Mawire
- Yulliana Mazvanya
- Maudy Mbasera
- Magret Mbono
- Cynthia Mhakayakora
- Nompumelelo Mhlanga
- Bester Mhosva
- Nomuhle Moyo
- Over Moyo
- Robert Moyo
- Charity Mpakami
چکیده
UNLABELLED Child stunting and anemia are intractable public health problems in developing countries and have profound short- and long-term consequences. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by the premise that environmental enteric dysfunction (EED) is a major underlying cause of both stunting and anemia, that chronic inflammation is the central characteristic of EED mediating these adverse effects, and that EED is primarily caused by high fecal ingestion due to living in conditions of poor water, sanitation, and hygiene (WASH). SHINE is a proof-of-concept, 2 × 2 factorial, cluster-randomized, community-based trial in 2 rural districts of Zimbabwe that will test the independent and combined effects of protecting babies from fecal ingestion (factor 1, operationalized through a WASH intervention) and optimizing nutritional adequacy of infant diet (factor 2, operationalized through an infant and young child feeding [IYCF] intervention) on length and hemoglobin at 18 months of age. Within SHINE we will measure 2 causal pathways. The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the 2 child health primary outcomes; it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices. We will also measure a range of household and individual characteristics, social interactions, and maternal capabilities for childcare, which we hypothesize will explain heterogeneity along these pathways. The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age; it will be elucidated by measuring biomarkers of intestinal structure and function (inflammation, regeneration, absorption, and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia among a subgroup of infants enrolled in an EED substudy. This article describes the rationale, design, and methods underlying the SHINE trial. CLINICAL TRIALS REGISTRATION NCT01824940.
منابع مشابه
The SHINE Trial Infant Feeding Intervention: Pilot Study of Effects on Maternal Learning and Infant Diet Quality in Rural Zimbabwe
The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is designed to measure the independent and combined effects of improved water, sanitation, and hygiene and improved infant feeding on child stunting and anemia in Zimbabwe. We developed and pilot-tested the infant feeding intervention delivered by 9 village health workers to 19 mothers of infants aged 7-12 months. Between September ...
متن کاملAssessment of Environmental Enteric Dysfunction in the SHINE Trial: Methods and Challenges
Environmental enteric dysfunction (EED) is a virtually ubiquitous, but poorly defined, disorder of the small intestine among people living in conditions of poverty, which begins early in infancy and persists. EED is characterized by altered gut structure and function, leading to reduced absorptive surface area and impaired intestinal barrier function. It is hypothesized that recurrent exposure ...
متن کاملDesign of an Intervention to Minimize Ingestion of Fecal Microbes by Young Children in Rural Zimbabwe
We sought to develop a water, sanitation, and hygiene (WASH) intervention to minimize fecal-oral transmission among children aged 0-18 months in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. We undertook 4 phases of formative research, comprising in-depth interviews, focus group discussions, behavior trials, and a combination of observations and microbiological sampling method...
متن کاملAssessing the Intestinal Microbiota in the SHINE Trial
Advances in DNA sequencing technology now allow us to explore the dynamics and functions of the microbes that inhabit the human body, the microbiota. Recent studies involving experimental animal models suggest a role of the gut microbiota in growth. However, the specific changes in the human gut microbiota that contribute to growth remain unclear, and studies investigating the gut microbiota as...
متن کاملAssessing Maternal Capabilities in the SHINE Trial: Highlighting a Hidden Link in the Causal Pathway to Child Health
A potential bottleneck for increasing the adoption of child health interventions has been limited attention to designing actions that are built on the essential role that caregivers play in determining their effectiveness. In the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial, we utilize the concept of maternal capabilities to examine participants' skills and attributes that affect ...
متن کاملTheory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach
Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy (theory failure), and failure to implement interventions as designed (program failure). These failures are important for both public health programs and randomized trials. In the Sanitation Hygiene and Infant N...
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ورودعنوان ژورنال:
دوره 61 شماره
صفحات -
تاریخ انتشار 2015