Comprehensive Anaemia Programme and Personalized Therapies (CAPPT)

Anaemia means that there are fewer red blood cells than normal in the blood or there is less haemoglobin than normal in each red blood cell. In either case, a reduced amount of oxygen is carried around in the bloodstream. Lack of iron is the most common cause of anaemia. This is called iron-deficiency anaemia. Iron deficiency anaemia during pregnancy is a huge problem in low and middle-income countries such as Nepal and India.
It is important to prevent anaemia in pregnancy due to the complications that are associated with low iron levels. Pregnant women who are anaemic are much more likely to die during childbirth than those women who are not and their infants are much more likely to be born small for gestational age.

A rise in haemoglobin during pregnancy is associated with improved outcomes. It is, therefore, imperative that a focus is placed on improving anaemia in pregnant women, especially in low and middle-income countries.

During pregnancy, women are particularly prone to becoming anaemic and it is a time when eating more iron than normal is recommended. Even then, oral supplements of iron are often still needed in order to prevent anaemia. Despite oral supplementation being recommended by both the Governments of India and Nepal, levels of anaemia remain alarmingly high. Compliance about taking medication may be an issue but other factors such cultural and social beliefs, access to iron rich food sources, other micronutrient deficiencies and inequalities to sharing and access to food in the household are also significant reasons why women remain anaemic.

This project is designed to address some of these issues by trialling a home based intervention that provides education, counselling and advice about anaemia, good food practises and provides a mechanism of behaviour change for barriers women face in improving their health during pregnancy. A health worker will attend the family home early in pregnancy to deliver this package of care and test haemoglobin levels so that tailored oral iron supplements can be initiated. A subsequent visit at around 22 weeks will reinforce practises and allow for further assessment of haemoglobin. Access to participatory women's group will further reinforce the messages and access to support. The aim of this intervention is an improved haemoglobin level at 28 weeks of pregnancy in this intervention group, when compared with a group of pregnant women who continue to have routine antenatal care. Those women whose anaemia becomes worse despite uptake of intervention and oral supplements, will be offered a blood test to investigate their condition more extensively and assess if there is a genetic reason why they may not respond to the current treatment. This would enable us to identify groups of women who would require a different intervention. This study is innovative in its home based and tailored approach. It is robust in its study design and has experts from many fields working in India, Nepal and the UK.

The overarching aim of this study is to provide robust evidence that the proposed intervention is feasible and works. By carrying it out in two countries with a large number of participants we hope to be able to show that the intervention works in different populations and is adaptable to the needs and variation across different groups. This enhances the prospect that it could be rolled out in different parts of the world most affected by the problem. We plan to work closely with international aid agencies and Governmental organisations within Nepal and India to enact change at a national level. Much thought has been put into the scalability of and cost of the intervention and will continue as we run the trial. This will maximise the potential to roll out the intervention rapidly at a national level if we find that in pregnant women, haemoglobin improves in response to the intervention.

Anaemia in pregnancy continues to be a significant global health problem, with iron deficiency anaemia (IDA) affecting almost half of the world's pregnant population. Given the adverse outcomes associated with anaemia in pregnancy for both fetus and mother, this problem requires urgent and novel investigation and treatments. Our intervention consists of timely pregnancy detection and tailored behavioural, educational and nutritional advice and oral iron therapy. This will be provided through 2 home visits: at 8-16 weeks and at 22 weeks.

Primary research question- Does a home-visiting intervention providing a tailored dosage of oral iron-folate supplementation along with a personalized package of nutrition education and counselling (the CAPPT intervention) supported by community-based participatory learning and action (PLA) women's groups increase haemoglobin levels at 28 weeks of pregnancy, compared with haemoglobin levels in women who undergo routine antenatal care?

Study Design- Two non-blinded cluster randomized controlled trials, in rural settings in India and Nepal, run in parallel with many features in common including data collection methods so as to allow some combined analysis. Both trials will include a control (routine care) arm and a combined intervention arm comprising intensive home-based counselling and tailored iron, plus provision of participatory learning and action women's groups (PLA).
The mean difference of the 28 weeks HemoCue haemoglobin concentration between groups is the primary outcome in the study. As secondary outcomes we will investigate food allocation, diversity and inequality issues as well as factors that influence non response including; compliance, underlying genetic associations, haemaglobinopathies and infection.

The trial will provide proof of concept for a feasible, scalable program that improves diets and reduces anaemia in pregnant women, which could be implemented in high anaemia burden areas in India and Nepal

Anaemia in pregnancy poses a huge problem to women and their unborn children, particularly in LMIC. This project aims to address the problem, trialling a new intervention, in two setting in India and Nepal, where burden is high.

Impact will be in several forms:
(1) Direct benefit to participants and their families
The aim of the intervention for the trial is to increase knowledge, awareness and facilitation of behavior change in pregnant women and their families. This will be done through a combination of home visits and participatory learning and action (PLA) groups in the community. The hope is that we can implement changes that can be sustained in these settings, benefiting the pregnant woman as well as the household she resides in. Through access to the program, women will be empowered to seek out alternative healthy behavior and nutrition practices.

(2) Public/ community education and engagement
We will publicise the project the local communities participating in Nepal and India, enabling wide dissemination of the aims and ambitions of the work and to help with recruitment. PLA groups will be available to women in the trial with tailored messages and education that chime with the CAPPT intervention and provide information about healthy behaviours and nutrition to the wider community. We will also engage the AIIMS academic and clinical community, providing workshops and focus groups showcasing the intervention to generate interest and excitement.

(3) International Engagement and Policy Change
Meaningful uptake of this project will involve implementation at a Government level. We have already begun working with Government Departments in India and Nepal. We will utilize our excellent existing connections to engage the Government departments with implementation of the trial, dissemination of the results through regular meeting and presentations of the work locally.
We will work with other organizations active in the regions and interested in maternal and child health such as UNICEF and the WHO. This will facilitate wider dissemination of the results of the trial, increase publicity and help with influencing national policy. We will run several engagement events across sites and through UCL to ensure an international presence for the project.
We will maintain information about the project through a dedicated Website, providing a timely means of updates and dissemination of results.

(4) Economic/ Societal benefit
Improved anaemia status in pregnant women will have a direct impact on maternal and neonatal morbidity and mortality. This has benefits for society as a whole, in terms of improved health of the country. There may also be indirect benefits to the economy of the country with less resources needed for managing complications during pregnancy and if women remain well this may help them to remain more active and productive during and after pregnancy.

(5) Enhanced training and attainment of best practices
A number of people will work on the project and will be able to acquire new skills that can be put to use again in the future. Our community health workers will all acquire skills that will make them appropriately placed to take on future health worker rolls in their communities, generating a valuable resource in the communities in which we will conduct the study as well as providing a cadre of individuals that can train future health workers. We will work together to enhance laboratory techniques and share expertise regarding genetic studies.

(6) Academic Impacts
Scientists and clinical academics directly working on the project will benefit from the experience of working on a multi-country project with access to several eminent groups. There are a number of areas of cross-fertilization between researchers involved in the projects allowing for transfer of expertise and new skills. The wider scientific community will also benefit through publications and presentations of our work.