The comprehensive anaemia programme and personalized therapies (CAPPT) trial testing the effect of home visits, tailored iron therapy and women’s groups to reduce anaemia in pregnant women in southern Nepal

INTERVENTION: Fifty‐four clusters (mean population 2582; range 1299 to 4865) meeting cluster eligibility criteria, each surrounded by a buffer zone, have been allocated into two study arms of 27 clusters. Restricted randomization was applied to maximize similarity with respect to cluster size (number of eligible women), caste, religion and travel time to a public health facility. In the control arm pregnant women receive routine antenatal care as per government protocols. In the intervention arm pregnant women receive a combination of two home counselling visits plus they and their families are invited to join participatory learning and action women’s groups in their community (PLA). Home visits and PLA are delivered by six female Nutrition Assistants (NAs) who are certified auxiliary nurse midwives or staff nurses hired by the Nepal implementing organisation HERD International. Home visiting intervention: Home visits are designed to work synergistically to encourage PLA group attendance, to reach women who cannot / do not leave their homes, and to engage family members in addressing anaemia. Each home visit comprises dialogical counselling, home‐based anaemia screening, and tailored IFA. The NA visits each pregnant woman twice at home, first at 12 to 21 weeks and second at 18 to 25 weeks. Ideally the gap between visits is 4 to 6 weeks, unless logistical constraints imposed by the COVID 19 pandemic disrupt activities. Home‐based tailored dialogical counselling: A dialogical approach is used to engage pregnant women and their families to think critically about the causes of anaemia in pregnancy in their household and community. The NA engages pregnant women and their families in a cycle of action and r CONDITION: Prevention and treatment of anaemia in pregnant women ; Pregnancy and Childbirth PRIMARY OUTCOME: Blood haemoglobin level is measured using a portable battery‐operated electronic Haemoglobin Photometer (HemoCue Hb 301+, Angelhom, Sweden) between 28 and 32 weeks’ gestation. Note that if logistical constraints imposed by the COVID‐19 pandemic disrupt follow‐up haemoglobin may be measured any time from 28 weeks to delivery SECONDARY OUTCOME: ; 1. Prevalence of anaemia in enrolled pregnant women, defined as % with blood haemoglobin <11g/dL measured using a portable battery‐operated electronic Haemoglobin Photometer (HemoCue Hb 301+, Angelhom, Sweden) between 28 and 32 weeks’ gestation; 2. Pregnant women’s Mid‐Upper Arm Circumference (MUAC) in cm, measured SECA head circumference tapes (93/42/EEC) between 28 and 32 weeks’ gestation; 3. Count of antenatal care visits (ANC) at a health facility, measured between 28 and 32 weeks’ gestation; 4. Mean Probability of micronutrient Adequacy (MPA) of 11 micronutrients in enrolled pregnant women's diets including vitamin A, riboflavin (B2), niacin (B3), pyridoxine (B6), cobalamin (B12), thiamin (B1), folate (B9), vitamin C iron, zinc and calcium, measured between 28 and 32 weeks’ gestation from duplicate quantitative 24‐hour dietary recalls taken 2 to 7 days apart; INCLUSION CRITERIA: Cluster INCLUSION CRITERIA: 1. Cluster does not adjoin the main East‐West which crosses the country Prithivi highway 2. Located in the southern part of Kapilbastu district (closer to the Indian border) where there is low population heterogeneity and low forest coverage 3. Rural area with no major market 4. Populated by predominantly Madhesi (plains ethnicity) population since the burden of anaemia is higher in this group 5. Projected population was =1100 and <3200 (although actual populations were found to be higher when the pre‐trial census was conducted) 6. Surrounded by a buffer zone of non‐study clusters Menstrual monitoring: 1. Married woman 2. Aged between 13 to 49 years 3. Able to respond to questions 4. Resident of study cluster