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1. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for school-age follow-up [version 1; peer review: 2 approved]

Author

Virginia Sauramba, Kuda Mutasa, SHINE Follow-up Trial team, Jean H. Humphrey, Clever Mazhanga, Joseph D. Piper, Idah Mapurisa, Gloria Mapako, Eunice Munyama, Tsitsi Mashedze, Dzivaidzo Chidhanguro, Marian Mwapaura, Naume V. Tavengwa, Lisa F. Langhaug, Robert Ntozini, Melanie Smuk, Elizabeth Allen, Andrew J. Prendergast, Maria Kuona, Kundai Sibanda, Thombizodwa Mashiri, Monica Tichagwa, Dzidzai Matemavi, Asinje Saidi, Soneni Nyoni, Eddington Mpofu, Manasa Mangwende, Batsirai Mutasa, Joice Tome, Laura E. Smith, Bernard Chasekwa, Melissa J. Gladstone, Jonathan C. Wells, Handrea Njovo, Mary Muchekeza, and Chandiwana Nyachowe

Subjects
Child, cognition, fitness, body composition, HIV, nutrition, eng, Medicine, Science
Abstract

Background: There is a need for follow-up of early-life stunting intervention trials into childhood to determine their long-term impact. A holistic school-age assessment of health, growth, physical and cognitive function will help to comprehensively characterise the sustained effects of early-life interventions. Methods: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe assessed the effects of improved infant and young child feeding (IYCF) and/or improved water, sanitation and hygiene (WASH) on stunting and anaemia at 18 months. Among children enrolled to SHINE, 1,275 have been followed up at 7-8 years of age (1,000 children who have not been exposed to HIV, 268 exposed to HIV antenatally who remain HIV negative and 7 HIV positive children). Children were assessed using the School-Age Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox, to measure their growth, body composition, cognitive and physical function. In parallel, a caregiver questionnaire assessed household demographics, socioeconomic status, adversity, nurturing, caregiver support, food and water insecurity. A monthly morbidity questionnaire is currently being administered by community health workers to evaluate school-age rates of infection and healthcare-seeking. The impact of the SHINE IYCF and WASH interventions, the early-life ‘exposome’, maternal HIV, and contemporary exposures on each school-age outcome will be assessed. We will also undertake an exploratory factor analysis to generate new, simpler metrics for assessment of cognition (COG-SAHARAN), growth (GROW-SAHARAN) and combined growth, cognitive and physical function (SUB-SAHARAN). The SUB-SAHARAN toolbox will be used to conduct annual assessments within the SHINE cohort from ages 8-12 years. Ethics and dissemination: Approval was obtained from Medical Research Council of Zimbabwe (08/02/21) and registered with Pan-African Clinical Trials Registry (PACTR202201828512110, 24/01/22). Primary caregivers provided written informed consent and children written assent. Findings will be disseminated through community sensitisation, peer-reviewed journals and stakeholders including the Zimbabwean Ministry of Health and Child Care.

Published
2023
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2. An evaluation of the isoniazid preventive therapy program performance for under-fives in Kwekwe City, January 2019 - December 2020: a descriptive cross-sectional study

Author

Nyashadzashe Cosmas Makova, Mary Muchekeza, Joconiah Chirenda, Addmore Chadambuka, Emmanuel Govha, Tsitsi Patience Juru, Notion Tafara Gombe, and Mufuta Tshimanga

Subjects
Cross-Sectional Studies, Antitubercular Agents, Isoniazid, Humans, Tuberculosis, HIV Infections, General Medicine, Contact Tracing, Child
Abstract

Childhood tuberculosis (TB) is underserved in resource-constrained endemic areas. Zimbabwe National Tuberculosis Program recommends tuberculosis prevention treatment for children aged5 years who are close contacts of smear-positive TB cases. The Isoniazid Preventive Therapy (IPT) program performance had never been evaluated since its inception in 2010. We therefore, assessed the IPT program's inputs, processes, outputs, and outcomes. We conducted a process evaluation using the logic model in Kwekwe City. We recruited twenty-seven health care workers from all the five municipal health facilities. Smear-positive guardians of under 5 children, health care workers, and registers were the study population. Data were collected using a questionnaire and checklists and presented as frequencies and proportions. The IPT program met requirements in provision of guidelines (10/10), screening tools (15/15) and on-the-job trainings done in all five health facilities. Isoniazid tablets supply and quarterly budgeting did not meet meeting program requirements. Fifty-nine out of 231 (25.5%) children contacts of sputum-positive TB patients were screened. Fifty-one of the 59 (86.4%) children were initiated on IPT, 42/51 (82.4%) completed the course, one developed TB, 3/51 were still on treatment and 5/51 were lost to follow up. No dropouts and deaths were recorded. Unavailability of drugs was a barrier to the IPT and negatively impacts the TB elimination program. Contact screening was the bottleneck in the successful implementation of the program. Adequate staff and provision of drugs might improve the program. We recommended the recruitment of more healthcare workers and the budget for the program.

Published
2022
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3. Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial

Author

Jean H Humphrey, Mduduzi N N Mbuya, Robert Ntozini, Lawrence H Moulton, Rebecca J Stoltzfus, Naume V Tavengwa, Kuda Mutasa, Florence Majo, Batsirai Mutasa, Goldberg Mangwadu, Cynthia M Chasokela, Ancikaria Chigumira, Bernard Chasekwa, Laura E Smith, James M Tielsch, Andrew D Jones, Amee R Manges, John A Maluccio, Andrew J Prendergast, Amee Manges, Cynthia Chasokela, William Heylar, Preston Hwena, George Kembo, Florence D Majo, Philippa Rambanepasi, Virginia Sauramba, 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, 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 M 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, 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, Rudo Mpedzisi, Elizabeth Mpofu, Estery Mpofu, Mavis Mtetwa, Juliet Muchakachi, Tsitsi Mudadada, Kudakwashe Mudzingwa, Mejury Mugwira, Tarsisio Mukarati, Anna Munana, Juliet Munazo, Otilia Munyeki, Patience Mupfeka, Gashirai Murangandi, Maria Muranganwa, Josphine Murenjekwa, Nothando Muringo, Tichafara Mushaninga, Florence Mutaja, Dorah Mutanha, Peregia Mutemeri, Beauty Mutero, Edina Muteya, Sophia Muvembi, Tandiwe Muzenda, Agnes Mwenjota, Sithembisiwe Ncube, Tendai Ndabambi, Nomsa Ndava, Elija Ndlovu, Eveln Nene, Enniah Ngazimbi, Atalia Ngwalati, Tafirenyika Nyama, Agnes Nzembe, Eunica Pabwaungana, Sekai Phiri, Ruwiza Pukuta, Melody Rambanapasi, Tambudzai Rera, Violet Samanga, Sinanzeni Shirichena, Chipiwa Shoko, More Shonhe, Cathrine Shuro, Juliah Sibanda, Edna Sibangani, Nikisi Sibangani, Norman Sibindi, Mercy Sitotombe, Pearson Siwawa, Magret Tagwirei, Pretty Taruvinga, Antony Tavagwisa, Esther Tete, Yeukai Tete, Elliot Thandiwe, Amonilla Tibugari, Stella Timothy, Rumbidzai Tongogara, Lancy Tshuma, Mirirayi Tsikira, Constance Tumba, Rumbidzayi Watinaye, Ethel Zhiradzango, Esther Zimunya, Leanmary Zinengwa, Magret Ziupfu, Job Ziyambe, James A Church, Amy Desai, Dadirai Fundira, Ethan Gough, Rukundo A Kambarami, Cynthia R Matare, Thokozile R Malaba, Tatenda Mupfudze, Francis Ngure, Val Curtis, Katherine L Dickin, Jean-Pierre Habicht, Collen Masimirembwa, Peter Morgan, Gretel H Pelto, Corinne Sheffner-Rogers, Roslyn Thelingwani, Paul Turner, Lindiwe Zungu, Tariro Makadzange, Hilda A Mujuru, Chandiwana Nyachowe, Rugare Chakadai, Gabriel Chanyau, Mary G Makamure, Humphrey Chiwariro, Tambudzai Mtetwa, Lisbern Maguwu, Simon Nyadundu, Tshebukani Moyo, Beauty Chayima, Lucy Mvindi, Pauline Rwenhamo, Shamiso Muzvarwandoga, Rumbidzai Chimukangara, Handrea Njovo, and Talent Makoni

Subjects
Male, Sanitation, Psychological intervention, Rural Health, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Pregnancy, Hygiene, 030212 general & internal medicine, Child, Infant Nutritional Physiological Phenomena, Growth Disorders, media_common, 2. Zero hunger, education.field_of_study, lcsh:Public aspects of medicine, Child Health, 1. No poverty, Pit latrine, Anemia, General Medicine, 6. Clean water, 3. Good health, Child, Preschool, Female, International development, Adult, Zimbabwe, Human Rights, media_common.quotation_subject, 030231 tropical medicine, Population, Standard score, Disease cluster, Article, 03 medical and health sciences, Water Supply, 030225 pediatrics, Political science, Environmental health, medicine, Humans, education, Infant, Water, lcsh:RA1-1270, medicine.disease, Malnutrition, Rural area
Abstract

Summary Background Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe. Methods We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940. Findings Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08–0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28–2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported. Interpretation Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone. Funding Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.

Published
2019
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