Research Study Question; Research Question Do home visits by CHCW to promote antenatal care lead to increase in ANC adherence and improvement in maternal and new born health in Bushenyi district, Uganda

Final Assignment: Dissertation B/ Project

Student Name:.Tibanyendera ..Deogratias

Module/Unit and Semester Name:. Dissertation 15a

Date of submission: 23.10.2014

First submission

By submitting this assignment I am certifying that it is all my own work and that I have quoted and referenced all the sources used in the answer.

Project title:

Home visits by Community Health Care Workers (CHCW) to promote Antenatal care (ANC) as a preventive intervention to improve Maternal and child health (MCH) in Uganda, Bushenyi District.

Research Question

Do home visits by CHCW to promote antenatal care lead to increase in ANC adherence and improvement in maternal and new born health in Bushenyi district, Uganda

A PROJECT PROPOSAL

SUBMITTED IN PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF

A MASTERS IN PUBLIC HEALTH FROM PEOPLES OPEN EDUCATION INITIATIVE –PEOPLES UNI, MANCHESTER UK.

Table of contents

	section	Content	Page
	1	Introduction	3
	2	Background	3
	3	Literature search	4
		3.1 Hypothesis	5
		3.2 Literature search process	6
		3.3 search results	6
		3.4 table of the search process	7
	4	Literature review	8
		4.1 literature review limitations	10
	5	Research question	10
	6	Study objectives	11
	7	Study design	11
		7.1 methodology	12
		7.2 study setting	14
		7.3 intervention plan	15
		7.4 outcome measures	18
	8	Qualitative performance evaluation	18
		8.1 Assessment	18
		8.2 sample selection	18
	9	Data collection	18
		9.1 data analysis	19
	10	Time frame	19
	11	Ethical considerations	22
	12	Limitations of the study	22
	13	Implications for future research	23
		References	23
		Appendix 1- summary of references	27

1.       Introduction

One of the gaps identified in the literature study was that the roles of CHCW were scanty and not specific in different countries hence giving varying results in terms of achievements towards MCH. Therefore this project will assign one specific role of preventive intervention to CHCW and find out their contribution in the area of maternal and child health at the community level. By conducting home visits to promote ANC as a preventive measure anticipating an ANC adherence and improvement in maternal and new born health.

Antenatal care (ANC) is one of the recommended interventions to reduce maternal mortality and neonatal mortality. Though there are high rates of ANC in most Sub-Saharan African countries, high rates of ANC coverage coexist with high maternal and neonatal mortality (WHO 2014). This precipitates a focus on the quality of ANC services especially provided that in most countries pregnant mothers attend ANC once than the recommended four ANC visits by the WHO. However, little empirical study exists on the home visits by CHCW to promote ANC in low-income countries and in particular Uganda. Most of the policies to promote the mother’s health  focus on improving economic and physical accessibility to increase the number of ANC visits to at least four times ( Finlayson and Downe 2013).

There is generally limited evidence on the effects of home visits by CHCW on ANC. In Northern Uganda a community intervention used CHCW to track mothers who had missed ANC appointments. Though the program led to increase in ANC attendance, it is not clear if this was as a result of CHCW intervention or other activities in the program like community sensitization and male partner access clubs to promote ANC (Le Roux I, M et al 2013)

Knowledge gaps exist in defining how to sustainably implement home visits by community-based interventions for maternal, newborn health, and how these interventions not only improve home care practices but also create demand for healthcare services in the broader health system

Cluster randomized control trial (cluster RCT) shall be used to measure the impact of CHCW home visits to promote ANC and the outcome on maternal and child health.

Such a study is beneficial to public health because, information on the effectiveness of these complementary community-based approaches for reducing neonatal mortality is necessary to frame policy for their inclusion in public health programs. Further, the relative value of preventive or promotive and treatment interventions are unclear especially if carried out by CHCW. Therefore this study is for the purpose of determining whether home visits to promote ANC by community health workers can reduce infant and neonatal deaths and stillbirths in resource-limited settings with poor access to health facility-based care.

2.       Background

Antenatal care (ANC) is one of the recommended measures by the WHO in reducing maternal as well as child deaths. The WHO further urges that every woman should at least adhere to four ANC visits including screening, detection and treatment of infections and warning signs during pregnancy. However in most rural developing world where health centers are rare, only 46% of women attend ANC for at least four visits with 23 % having no ANC at all. Though a substantial percentage of women in developing countries attend ANC visit, it is normally during the late stages of the pregnancy when it may be too late to rectify any complications (WHO, 2013). Every day, approximately 800 women die from preventable causes related to pregnancy and childbirth. In 2008 over 300,000 maternal deaths occurred worldwide and almost all of these in low- and middle-income countries (WHO et al 2010). It is also estimated that every year 3 million newborn babies die within the first month of life and between 2.1 to 3.8 million babies are stillborn (Lawn JE et al 2011).

ANC is essential in saving the lives of the mothers and babies since it acts as a remedy before child births and early post natal period. ANC gives an opportunity to the mother to detect any ailments during pregnancy as well as promoting healthy home practices, good health seeking behaviors and all these influence the women to give birth at a health facility (UNICEF 2013)

Effects on mothers

An estimated 25 percent of maternal deaths in developing countries occur during pregnancy. This varies between countries where there is unsafe abortion, violence and diseases. Other causes include hypertension and ante partum hemorrhage which are all attributed to inadequate care during pregnancy. Malaria, anemia, HIV/AIDs and malnutrition are responsible for maternal and newborn morbidity and mortality where prevalence of these conditions are high (WHO, 2014b)

Effects on babies:

In sub-Saharan Africa there are almost 900,000 still births during the last trimester during pregnancy. Babies who die immediately after birth account for two –thirds of all still births in the developing countries where mortality rate is 22 per 1000 births. Nearly six out of seven still births are caused by maternal infections, and new born are usually affected by illnesses during pregnancy including preterm birth and restricted fetal growth fetal alcohol syndrome and congenital infections  (WHO et al 2010)

In Uganda, women who had at least four ANC visits  between 2008 to 2012 was 47% and one ANC  visit was 93.3% , and neonatal mortality at 45/1000 live births (UNICEF, 2013) which indicates that mothers attend ANC once and they visit again the hospital when they are ready to deliver. This poses a high risk to pregnant women or risk to the baby may be detected late at the time of delivery when it is late to provide any remedy. Hence this project wants to fill that gap and ensure that pregnant mothers fulfill the WHO recommendation of four ANC visits. The late and inconsistent ANC attendance pose a public health problem. Late detection of pregnancy related illnesses increases the rate of adverse outcomes to the mother and the baby (WHO, 2003)

Community health workers (CHCW) can successfully perform a variety of services and activities, including the delivery of basic health care, health education, and promoting uptake of facility-based health care and preventive education for example promote ANC. ( Ahorlu, C,K. et al 2009)

Literature review demonstrate that CHCW community based programs can be essential in reducing maternal and new born health  in low income settings if a variety of interventions were channeled through CHCW community based program though the information is scanty.

3.       Literature search

P - pregnant women between 17 to 35 years in Bushenyi district, Uganda
I - Home visits to promote  ANC visits to at least four
C- Households of pregnant women that received  ANC Home visits by CHCW versus households of pregnant women that did not receive home visits by CHCW
O – Adherence to ANC - percentage of mothers who had at least 4 or more ANC visits at a health center in the last 6 months and Reduction in Neonatal mortality- percentage reduction in neonatal mortality by 10% from 45/1000 live births to 40.5/1000 live births.

Research Question: Do home visits by CHCW to promote antenatal care lead to increase in ANC adherence and improvement in maternal and new born health in Bushenyi district, Uganda

3.1 Hypothesis

Complex interventions, such as a CHCW program, need to be supported by a convincing theory of change describing the hypothesized mechanisms linking the intervention to outcomes.(Van Belle, S,B et al. 2010) I  postulate that the home visits by CHCW while promoting ANC will lead to increase in  ANC visits and impact on newborn health through the following pathways.

First, the sensitization on ANC benefits by CHCW raises awareness of ANC and can also provide a source of motivation for attending ANC.CHCW counseling may also increase ANC attendance by simply informing women of the location of the nearest ANC clinic. This could be a particularly relevant factor in the study areas where women may have moved to the location recently from other parts of the country and may not yet be familiar with the location of ANC clinics. This is further supported by a randomized controlled trial in Canada which showed that counseling by CHCW can improve uptake of different antenatal and community services (Tough, S,C. et al. 2006)

Second, the CHCW visit itself may serve as a reminder to women who were already planning to attend ANC at the time of the CHCW visit. This can be similar to a study that investigated the use of CHCW for improving adherence to medications by patients with acute coronary syndrome that was successful in reminding people of the need. (O'Riordan M 2014)

 Third, CHCW visits may also be a source of normative social influence. In order to be liked and accepted, people tend to conform to social expectation, such as the expectation that pregnant women should attend ANC (Satterfield, D, et al. 2002)

3.2 Literature search process

Key words included: maternal and child health, community health workers, antenatal care, CHCW performance evaluation, home visits, MCH preventive interventions, developing countries,

The MESH terms included MCH preventive intervention, ANC adherence , CHCW Case Management; Community Health Nursing; Infant, Newborn; Medicaid; Outcome Assessment (Health Care); Pregnancy Outcome; Pregnancy, High-Risk; Prenatal Care /utilization. To increase on the articles CHCW and ANC, CHCW preventive intervention and developing countries were added

The literature search included: Pub Med, the Cochrane Controlled Trials Register in the Cochrane Library, Excerpta Medica Database (EMBASE), Health Services Technology, Administration, and Research (HealthSTAR), the ISI Web of Science, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PLOS and clinical trials web sites. Included were articles in English published from the beginning of each database up to 2015. For all included articles, a lateral search in Pub Med by using the “related articles” link.  Also the searched articles included reviews and for conference proceedings/abstracts.

Since antenatal care practice indicators were not a primary outcome and were examined only as explanatory variables for any effect on mortality, I did not search for them independently. I did not employ any filter to limit the search to developing country (resource-limited) settings. However, I included only trials that had been conducted in countries with a low or middle level of human development.

Inclusion criteria included

·         comparing groups that received different experimental interventions, including home visits for antenatal care by community health workers, with a control group that did not receive any home-based intervention by community health workers during the antenatal period

·         The trial population had to be composed of pregnant mothers in resource-limited settings with poor access to health-facility-based care.

·         Trials were required to include home-based experimental interventions by community health workers in the antenatal period.

·         Interventions during pregnancy could comprise one or more of the following: (i) promotion of antenatal care; (ii) health education and/or counseling of the mother regarding desirable practices during pregnancy; (iii) promotion of delivery in a hospital or at home by a skilled birth attendant; and (iv) education about safe and/or clean delivery practices.

·         Interventions were required to be preventive and have been delivered at the household level by Community Health Workers

·         Only studies conducted in low- and middle-income countries, as described by The World Bank at time of study initiation, and only those articles published from 1990 to present were included. This time period was chosen to coincide with the re-emergence of the popularity of CHCW programs(Lehmann U, Sanders D. 2007),

Exclusion criteria

·         Articles were excluded if they did not meet the inclusion criteria or:

·         If interventions were not clear or in studies with multiple intervention techniques where it was not possible to separate out specific preventive intervention outcomes.

·         If the description of CHCWs was insufficient or their role in the intervention was ill-defined.

·         If multiple health cadres were responsible for the intervention’s implementation and the CHCW’s specific role could not be differentiated.

·         studies with the home visit ANC was conducted  by other health administrators other than CHCW

·         articles not in English were excluded since there was not funds and time for translation

3.3 Search results           

A total of 190 studies were initially identified and through the screening process a total of 14 articles were included in the review. Studies came from ten different countries, like Bangladesh, India, Asia, Uganda, Malawi, Tanzania, Pakistan, Ethiopia, Ghana, and Nigeria. Studies  consisted of randomized controlled trials, cluster randomized controlled trials, ,systematic reviews, field trials , impact surveys and other, case control and cross sectional studies. Overall quality of evidence was found to be moderate. Five main preventive intervention categories emerged: health education, ANC promotion, breastfeeding promotion, essential newborn care and psychosocial support. All categories showed some evidence for the effectiveness of CHCW in ANC, however they were found to be especially effective in promoting mother and newborn health.

3.4 Table search process

Potential relevant references identified and screened for  retrieval  #190

potentially appropriate references  #137

Finalreferences  considered  # 14

obviously irrelevant

excluded material not

connected to the

study  #53

references excluded due to , Not

intervention by CHCW,

language not English, not

related to ANC, outcomes not

related to MCH mortality and

morbidity , no Home visits,

abstracts #117

references satisfying the criteria

for inclusion appropriate

references # 20

excluded because of - abstracts

and not detailed and with no

research related study

= 6

3.5 Literature search flow chat

	Study design	Number of studies
1	Cluster randomized trial	5
2	Cluster randomized controlled trial	4
3	Meta-analysis	1
4	Impact evaluation survey	1
5	Systematic review	1
6	Repeated cross sectional study	1
7	Field trial	1
		Total 14

4.       Literature review

The New hints cluster–randomized trial in Ghana showed the effects of home visits by trained community–based surveillance volunteers (CBSVs) on neonatal mortality and home care practices The CBSVs in the study zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and promote safe motherhood, ANC adherence and make referrals.  As a result, there was a reduction in overall neonatal mortality by 8% (Kirkwood, B, R, et al. 2013)

A repeated cross-sectional study to identify the connection between ANC visits by CHCW and facility based delivery was carried out in Tanzania. The study measured the relationship between the number of home visits – up to four and facility based delivery. A higher proportion of home visits was realized in the urban areas (from two to four home visits) and increase in facility based delivery.  However there was no significant relationship of the CHCW home visits and increased facility based delivery in the rural areas (Seung-Ah Choe, et al. 2015)

In Tanzania a cluster randomized controlled trial investigated the effect of home based counseling by CHCW on new born care practices. The CHCW were tasked to make home visits and identify pregnant women and counsel them on newborn care practices, as well as promote post natal care. In one trial a relative decline in infant mortality was documented. (Penfold, S, et al. 2014).

In an evaluation of a cluster – randomized controlled trial  in Bangladesh for community based new born interventions, CHCW were tasked to identify  pregnant women and encourage them to make at least two ANC visits , sensitize mothers on preventive care practices , access newborn illness and carry out at least four post natal visits and make referrals . The study realized high coverage of ANC visits (two visits) by 91%, postnatal visits by 69%. Though there was no impact on neonatal mortality, improvements in newborn care practices were evident. (Bhandari, N et al. 2012)

A study by Bhutta et al (2008) in Pakistan investigated the feasibility of using CHCW and traditional birth attendants in improving antenatal care. Training on essential maternal and newborn care was provided to the CHCW and they were supposed to liaise with the traditional birth attendants. The intervention realized a reduction in neonatal mortality from 57.3 to 41.3 per 1000 live births. Facility based deliveries increased from 18% to 30% and a significant increase in new born care practices.

A feasibility study on the effect of CHCW on neonatal mortality within areas with weak health systems, or low utilization showed positive results in reduction of neonatal mortality and increase in utilization of health services in trials and demonstration projects in Asia (Kumar, V, et al. 2008).  In cluster randomized trials conducted in Uganda, home visits by CHCW for preventive care as well as curative care was able to reduce neonatal mortality by 30% (Waiswa, P, et al. 2012)

Studies in Bangladesh, India and Pakistan on showed that home visits can reduce new born deaths in developing settings by 30% (Bang, A, T, et al. 1999). The visits led to improvement in new born care practices, skin to skin contact, delayed bathing, improved hygiene, and initiation of breastfeeding and code care.

In sub Saharan Africa, evidence is still limited. In a multi-country study involving Burkina Faso, South Africa and Uganda antenatal peer counseling by CHCWs improved prevalence of exclusive breastfeeding (Tylleskar, T, et al. 2011). In western Uganda, home visits by CHCWs targeting children less than five years reportedly reduced prevalence of diarrheal diseases and fever as well as improved use of child health services (Brenner, J,L, et al . 2011).

A systematic review by Gogia S, and Sachdev, H,S.( 2010).in the developing countries , discovered that home visits by CHCW led to increase in ANC  visits, immunization coverage, breast feeding and code care  (Gogia S, and Sachdev, H,S. 2010). A reduction in newborn deaths in areas of universal coverage of CHCW has potential to reduce maternal and child mortality especially in communities well served by primary health facilities. (Darmstadt, G. etal, 2005)

In Malawi, a study using cluster randomized control design evaluated the effect of home based counseling on maternal and child health outcomes. Areas receiving home base counseling reported increase in exclusive breastfeeding in the first six months by 20% as opposed to the control areas. However there was no conclusive evidence on any reduction in neonatal mortality (Lewycka, S ET al.2013)

A cluster – randomized /quasi randomized trials consisting of 18 clusters to identify the impact of CHCW on neonatal mortality in developing countries as a result of using community based intervention care packages, discovered that, there was not any reduction in maternal mortality though there was substantial reduction in maternal morbidity 28%, neonatal mortality 69%, still births 66% and prenatal deaths by 82%. The study also led to increase in pregnancy related referrals by 40% as well as increase initiation of breast feeding by 94% (Lassi, Z, S. et al. 2010)

All reviews except one (Bhandari N, et al.2012) reported CHCW home visits specific outcomes, increasing number of home visits. Other most reported outcomes as a result of CHCW include maternal, newborn morbidity and mortality, immunization rates, breast feeding, referral, ANC and PNC utilization.

In conclusion therefore, most reviews included several outcomes as a result of CHCW home visit interventions but this study seeks to analyze and deduce strong evidence on the value of CHCW in promoting ANC as an intervention. While the evidences presents good results as a result of CHCW and ANC , evidence still lacks on whether CHCW home visits while promoting ANC may lead to adherence to at least 4 home visits and improved neonatal outcomes  which hence will be the basis for the study.

4.1 Limitations

The data may not be conclusive due to the fact that the pregnant women residing in the intervention areas  could have sought care outside the study area and the studies do not present any control measures on the issue(Bang, A,T, et al.1999).

Moreover, the neonatal mortality, may have improved without increase in ANC visits, this can be possible to the pregnant educated mothers who are aware of the new born care practices prior to the intervention. (Kirkwood, BR, et al. 2013)

More to that the review was basically to identify studies where CHCW performed prevention only activities,  this means that other evidence to show their effectiveness in this area may be been omitted in particular where there were multiple intervention programs. (Perry, H, et al. 2009). But authors Perry and Zullinger (2009) compiled a list of other interventions areas for CHCW for further reading.

There is limited knowledge and research on  antenatal visits, though with some studies carried out on postnatal care by CHCW and neonatal care in eastern Uganda(Waiswa, P, et al . 2012)  , this lack in study  calls for the proposed project on the antenatal care visits and its implications on neonatal health.

Some studies Bhutta et al (2008), (Bhandari, N, et al. 2012) have multiple outcome focus like neonatal mortality, hospital based deliveries, PMTCT and breastfeeding outcomes which may not conform to the study area in particular and the outcomes may be different.

Although the study in Tanzania (Penfold, S, et al, 2014) may have covered a large number of pregnant women to improve their ANC and MTCT, however it is very difficult to measure if the increase in ANC visits was because of the need for ANC purposes or to know their HIV status.

.

5.       Research question

Do home visits by CHCW to promote antenatal care (ANC) lead to an increase in ANC adherence and improve maternal and new born health in the Bushenyi district, Uganda

The study hypotheses that there will be at least an increase in ANC visits from the present 30% to 50% after an 11 months intervention of this project. The interventions hopes to improve the ANC adherence from a mean of 1 visit to 4or more as recommended visits by the WHO. Nationally, the average one ANC visit is97% and for Bushenyi district the study intervention area is 30%. While nationally the average women who have four or more ANC coverage is 47% (UNICEF 2013). A cross section baseline study was conducted to increase birth preparedness in three districts in eastern Uganda (LigaT et al 2015) was able to realize a 34% increase of one ANC visits  over 12 months hence 20% increase in ANC visits in three sub countries of one district is a realistic target over 11 months.

The study also hypotheses that there will be an improvement in neonatal mortality rates by 10%; a reduction from 45 per 1000 live births to 40.5 per 1000 live births. (UNICEF 2013). A similar study in western Uganda by Bremmer,J (2011) the intervention let to a relative decline of 53% in child deaths over an 18 months period, hence an 11 months intervention can achieve 10% reduction in neonatal deaths

Definitions 

Home visits         according to the Segens Medical dictionary (2012) is a visit conducted by a health personnel to a patient’s home. The visits have to be face to face contact with the patient with the aim to offer domiciliary consultations and counseling.

Antenatal care visit as a preventive health care type is where pregnant mothers attend regular checkups to allow health personnel to treat and prevent potential pregnancy related complications during the pregnancy. The services include advice on lifestyle and detection of problems in pregnancy such as edema and preeclampsia.

A newborn infant, or neonate, is a child under 28 days of age. During these first 28 days of life, the child is at highest risk of dying. It is thus crucial that appropriate feeding and care are provided during this period, both to improve the child’s chances of survival and to lay the foundations for a healthy life.

6.       Study objectives 

Primary objective:

The primary objective of the study is to test whether home visits by CHCW can lead to increase in ANC visits during the 11 months project intervention, from 30% to 50%, the hypothesis is that regular home visits reminding the pregnant mothers of the ANC will impel others to adhere to the regular ANC visits as recommended by WHO.

Secondary objective is that the regular home visits will reduce neonatal morbidity and mortality, because ANC and other advice on sanitation and immunization should improve newborn health.

7.       Study design

7.1 Methodology

Cluster randomized control trial(C-RCT) shall be used for this study. Three of the six health centers that offer ANC in the district shall be randomly selected as the intervention sites, where the women in the three randomized villages shall be asked to attend the ANC, this is because the same ANC health personnel shall be part of the study hence it is important to designate specific health centers for this study. Women shall be clustered by places of origin and their proximity to the health center. Cluster -RCT was a preferred choice because it is able to compare the intervention group and the control group and it ensures equal side groups for easy comparison of statistics.

For the start all women in the 6 villages shall be sensitized on the benefits of ANC and will be explained about the study objectives, thereafter only the women in the three intervention villages shall benefit from the home visits. Hence this means that the study will not ignore completely the control group.

The Pregnant women in the 3 control villages will not be considered for the study home visits , as any project that is implemented in a particular area , but that does not mean they will be prohibited from ANC services or other government programs that are aimed at increasing ANC visits. They will continue accessing any health center for any ANC needs thought their data will not be taken.  

To prevent contamination, proximity shall be considered and women will be asked where they prefer to go for ANC visit , probably to the nearest health center and its where they will be asked to attend the ANC , hence it will not make visits increase because they will have gone to the same health center in absence of the intervention. Cluster RCT was preferred against simple RCT where pregnant women are randomized.  This option allows a bigger number of women in the same geographical areas to be considered for the study. The option also allows direct and indirect effects of the study to be evaluated.

Advantages of Cluster RCT

·         It is easy to administer and manage since data from designated health centers is easily collected

·         If at all  the study proves ineffective , the control group is saved from the wasteful intervention

·         When seeking consent it becomes easier to choose a population, define a cluster in which a trial will take place and then seek consent. This conforms to Zelens M (1990) approach to individuals select clusters and consent is sought after randomization, but to individual clusters you need to inform the selected seek consent to the study participants before they are considered for the study.

·         It is easy to prevent contamination across individuals  in this situation because women in the same village (three villages) shall be part of the study hence any cross discussion or sharing of information does not contaminate the study as would have been the case if women were individually selected across villages.

·         It is easy to measure the study outcomes at the clustered health centers because women shall have ANC visit at the selected health centers hence it is easier to collect statistics.

·         With the cluster RCT it gives room for comparison purposes and it is easy to tell if the study made a difference or not. By comparing the women in the central study who received home visits than those who did not.

Disadvantages

·         It deprives the pregnant women in the control study of the essential education and sensitization of the home visits and ANC education which may have made a difference in their lives – but as said as any project, it cannot be applied in the whole country and It is a trial hence with its success other villages will also benefit.

·         This study as compared to individual randomization needs more participants to get greater statistical power hence the need to get 210 women participants if better statistics are to be of substance.

·         Individuals consent is in this case ignored but pregnant women who opt not to be part of the study will be allowed their consent freedom or respect of individual consent is paramount

·         The level of education and literacy may be different across villages hence giving varying results. Because if in one village more women are educated they tend to take on the messages positively than the uneducated

·         The ANC health personnel may give more attention to pregnant women under trial, because of the close attention and individual data required which may not go down well with other women under the study. However they will be asked to render the same time and care as all women in the village.

7.1. Target population and sample selection     

The target population shall be the pregnant women in, the Bushenyi district, Uganda. The mean age of women to be included in the study will be ranging from 17 to 34 years. None of the studies will be limited to women in the first trimester of pregnancy but also women in the second trimester who have not had any ANC visit or those who have not had 4 ANCs visits and who still have time to be able to complete at least four ANC visits. The Study will report the number and duration of prenatal home visits per woman. Prenatal care utilization will be measured with a scale for adequacy of care use or by number of visits.

All the six health centers are classified as health center three (111) according to the ministry of health Uganda. Health Center III (HCIII) are at Sub-county level serving an estimated population of 2000 peoples ,the standard level staffing for HCIII is 1 Senior Clinical Officer, 1 Clinical Officer, 2 Mid-wives, 1 Nursing Officer Nursing, 3 Enrolled Nurses, 1 Laboratory Technician, 1 Laboratory Assistant, 3 Nursing Assistants, and 1 Health Assistant. HCIIIs provide basic preventative, promotive and curative care and provides support supervision of the community and HCIIs under its jurisdiction. There are provisions for laboratory services for diagnosis, maternity care and first referral cover for the sub-county. (MUIPH/HAP 2012)
The six villages are in geographical proximity to each other. The terrain is a mountainous nature and with poor infrastructure which poses a risk for women to access ANC visits. The literacy level in the areas is 55% .The region is known for agriculture with over 95 % of the population dependent on agriculture. Fertility in this area is around 6.6 children per women which is among the highest in Uganda, the total average population in the six sub-counties of the intervention is 253,621(UBOS 2014).

Study participants will be selected from the three of the six counties and clustered according to their counties or villages and other 3 as control sites where the women shall not receive home visits. The pregnant women who shall be identified shall be allocated sites where they are supposed to attend their ANCs.

As part of the study, the three intervention health centers that offer ANC shall be randomly selected, the stratified health centers shall be categorized in terms of location, and the capability and capacity to handle ANC before randomization. Of the three study  villages with ANC health centers each village randomly selected for the study will be allocated CHCW and they will randomly identify pregnant mothers at least 210shall be identified , 70 from each village .

Sample size calculation based on expected difference in ANC uptake from 30% to 50%: Group sample sizes of 94 in group one and 94 in group two achieve 80% power to detect a difference between the group proportions of 20%. The proportion in group one (the treatment group) is assumed to be 30% under the null hypothesis and 50% under the alternative hypothesis. The proportion in group two (the control group) is 30%. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500. (Hintze J. 2008). 

However this sample size calculation assumes randomization of the women and not cluster-RCT. For the sample size calculation of the cluster-RCT, I need the intra-class correlation coefficient which measures how more similar women in one village behave compared to the other villages. Hence, I need to increase the sample size because of the cluster-RCT and because of loss to follow-up to 210 women in intervention and 210 women in the control group (70 women per village).

Pregnant women in their first trimester or women in the second trimester who have not had 4 ANC visits at the time of the study will be eligible for inclusion. Studies will be required to report prenatal care utilization, pre-term birth (as defined in the primary study), gestational age at birth, and/or birth weight. The study intervention will be a standalone ANC program though does not interfere with the preexisting ANC government program.

Inclusion criteria of pregnant women for the study

·         Pregnant women in their first and second trimester  who have not as yet attended any ANC or have not completed four ANC  visits

·         Pregnant women who give consent to participate in the study

·         Pregnant women between  17 and 35 years of age

Exclusion criteria

·         Pregnant women who will not provide consent to participate in the study

·         Women in the third trimester – since they may not be able to complete the 4 or more ANC visits

·         Pregnant women who have benefited from the same study 6 months prior to the study or any similar study that may be targeting same women

·         Pregnant women who have already completed four or more ANC visits

·         Pregnant women with disability shall also be excluded because they receive domiciliary care (Home based ANC by health professionals), and since they don’t visits hospitals but benefit from home based care they are excluded.

7.2 Study Setting

Uganda is a land-locked country located in East Africa, and lies to the north along the equator. Uganda has a projected population of 32.4 million people. Landmass is about 241,038 km² in size and the country has a population density of about 137/km². An estimated 86% of the population live in rural areas, and practice mainly peasant farming. Nationally about 97 % of pregnant women make at least one antenatal care consultation and 52 % make four antenatal consultations, but less than 50 % deliver with the help of a skilled attendant, and deliveries at health facilities have remained low (42%), (MangwiAyiasi,R et al. 2014).

Bushenyi district in South Western Uganda is bordered by Kasese district to the north, Kamwenge district and Ibanda district to the northeast, Mbarara district to the east and the south-east, Ntungamo district to the south, Rukungiri district to the southwest and the Democratic Republic of the Congo to the west. The district is made up of twelve sub counties of Bushenyi D, Bitooma, Ibaare, Bushenyi E, Bushenyi C, Kyabugimbi, Bushenyi A, Kyeizooba, and Ruhumuro, together with central division, Nyakabirizi division and Ishaka division. The district covers 4,292.5 square kilometers (1,657.3 sq. miles) of land, open water, wetland and protected national forest reserve (UBOS 2007)

In 2010 the population of Bushenyi was estimated at 916,400 with an annual growth rate of 3%. Only 6 of the 10 medical facilities offer ANC hence it is in these facilities that the project shall be implemented .Kyeizooba, Bushenyi HC, Kakanju, Kabushaho, Ishaka Adventist and Bishop Comboni hospital. (Bushenyi district 2012) the district ANC coverage is 30% and neonatal mortality rate is 45/1.000 live births, (UNICEF 2013) this project shall reduce the ANC coverage from 30% to 40% and reduce neonatal mortality by 10% from 45/1000 live births to 40.5/1000 live births after the intervention.

Since the year 2000, the delivery of health services in Uganda has been decentralized to district level. The Ministry of Health (MoH) plays a stewardship role, providing leadership, standards, funding and policies. On the other hand, districts are responsible for implementation and service delivery. Below the district level are Health Sub-Districts (HSDs), which are administrative zones with about 10 to 20 lower level health facilities. Therefore the district health office has the mandate to authorize the study since it is autonomous (MOH/MUSPH. 2012).

7.3 Intervention Plan

CHCWs will be recruited from the community, based on criteria stipulated in the national Village Health Team (as referred to by the Uganda Ministry of health guidelines but same as CHCW): a permanent resident of the community, literate and willing to work as a volunteer. A preference will be given to mature females already doing some community health work since pregnant women find it easy to discuss ANC matters with fellow women .

Selection process: CHCW posts will be advertised according to criteria set using Ministry of Health village health team criteria, the community will identify a selection team and the candidates will be interviewed and CHCW posts filled. The study will need 15 CHCW.

Pregnant women shall be selected, using systematic sampling. The CHCW shall be allocated villages and they randomly conduct door to door visits to identify women that are potentially eligible. This also eliminates selection bias than if women were self-selected since they may not be a representative of the pregnant women.

CHCW responsibilities:

·         Visit all homes in the neighborhoods in which they are assigned every months and providing antenatal counseling an encouraging pregnant mothers to make at least 4 ANC visits and other information relevant for pregnant mothers like immunization, baby care  and mother nutrition.

·         Identify pregnant women during home visits and refer them to ANC (by providing a referral form to the woman with a referral identification number and the name of the designated study ANC health center). All pregnant women who will be  identified during the CHCW home visits and specifically counseled by the CHCW on the importance of early ANC visits and ANC,.

·         Routinely revisit all identified pregnant women to verify whether they have visited ANC and to promote ANC uptake through information and education. CHCW will be instructed to routinely revisit all pregnant women they identified in the community within two weeks after the initial visit.  Each CHCW should at least visit each home 4 times before the closure of the project

·         Follow up pregnant women who will have missed a scheduled ANC. During the weekly routine meeting with the CHCW, they then requested the CHCW who worked in the neighborhood where a pregnant woman who had missed a scheduled appointment lived, to specifically follow up with that woman and to remind and encourage her to return to the ANC facility.

Therefore the steps involved include 1- identification of families where pregnant women are located, 2- apply the inclusion and exclusion criteria 3:- offer ANC education, 4 refer the pregnant women for ANC; and 5 follow up.

CHCW training:

·         There will be a five-day training on preventive and promotive maternal and newborn care and counseling skills,

·         Teaching methods include participatory discussion, practical demonstrations and role-playing

·         CHCW will received a five-day training in the delivery of the intervention plus a two- to three-day training on the monitoring and evaluation tools used as part of the intervention. Trainings will be conducted by members of the research team over the course of two weeks. In addition to specific knowledge about pregnancy and maternal and child health, the training will include communication and counseling skills, monitoring and evaluation, and data collection and management.

Home visits during pregnancy

·         First pregnancy visit (Target: as early as possible up to 2nd trimester )

·         Counsel on and refer for ANC including tetanus immunization and malaria prevention

·         Counsel on birth preparedness and clean delivery practices

·         Counsel on and assess danger signs of pregnancy, refer if present

Second pregnancy visit (Target: in third trimester)

·         Counsel on birth preparedness and clean delivery practices

·         Counsel on and assess danger signs of pregnancy, refer if present

·         Counsel on newborn care practices immediately following delivery (e.g. placing the baby skin-to-skin, ensuring warmth, initiating breastfeeding, hygienic cord care)

·         .

Management and deployment

CHCWs will be given a set of materials including a register, picture-based counseling cards on birth preparedness and maternal and newborn care

For easy identification they will be given branded t-shirts and identity cards

‘Super’ CHCWs nominated as leaders will be tasked with mobilizing and encouraging fellow CHCWs and serving as supervisors where health workers are not available

A CHCW supervisor will liaise with the district health officer and the health personnel within ANC designate clinics. In addition, monthly meetings with the CHCW and ANC clinic based personnel in each of the three study centers shall be necessary. At these meetings, the CHCW will share and discuss obstacles they are facing in performing their work and possible approaches to overcome them. In addition, the coordinator will share with the intervention team the latest data on the number of pregnant women visited in each cluster.

 At the ANC clinic level , ANC health personnel will be in charge of supervising CHCW activities and referrals and responsible for the coordination of reporting on the progress at the clinics;, ensure that pregnant women who missed clinic appointments received CHCW visits, and served as a conduit between the CHCW, clinic staff, and the trial project team.

The CHCW shall identify at least 2 pregnant women per day during the selection process which means that for the first week each CHCW should have recruited 14 women which makes a total of 210 women for the intervention.

Each pregnant woman shall be visited 4 times before delivery. This means once every 2 months the CHCW have to visit their allocated pregnant women. Each CHCW shall be allocated 14pregnantwomen .The allocations shall be based on geographical proximity. This is also to maintain familiarity and not make outsiders or not familiar persons within the village be involved in a new location. This promotes friendly discussion and trust especially for confidentiality. Each CHCW is expected to do 56 home visits which translates to 840home visits on the intervention area and pregnant women.

Pregnant women in the control women of about 200 women as said at the start of the project will also be included in the briefing and sensitization on the importance of ANC, dangers of missing ANC, and they will also be encouraged at the session to attend to ANC and no further activities with them and   they will not be involved in home visits.  This will later make it possible to compare the results on how home visits may influence ANC visits by comparing the two groups. The information from the three control villages and health centers shall be compared to the intervention health centers.

Important data to be collected

CHCW during home visits, are supposed to introduce themselves and seek permission whether to go ahead with record keeping in case the person is not ready for the hem visit a later date can be arranged.

-          Age of the pregnant women

-          Number of home ANC  visits made so far ( because if a women has already made 4 or more she will be excluded from the study

-          Date of visits

-          Duration of pregnancy (gestation period)

-          Number of referrals made

-          Geographical location and marked by code / or house code number

By ANC health personnel at the health center

-          Age and gestation period

-          Ailments and complications

-          Indicate number of visits and scheduled visits for easy follow up in case of non-adherence

There will be personal confounding where individual women data or the intervention group shall be taken .Hence pregnant women attending ANCs visits shall be the confounding variable and as said their individual data shall be taken and ANC visit attended to by a designated ANC health personal at the health center. The possible confounders include: age of the women, geographical location, Level of education, history of drug use, previous miscarriages, ethnicity and race, number of children, number of pregnancy, family composition, marital status, and social economic status.

7.4 Outcome measures

The specific outcomes are: Increase in ANC visits from 1 to 4 or more and improved newborn health

Indicators will include:

·         proportion of pregnant women who have attended antenatal care four or more times;

·         proportion of neonates who survive after the 28^th day after birth with no complications

Hypothesis testing                                                      

The hypotheses is that: the intervention will lead to

1. % increase of pregnant women attending ANC at least four times (from 30% to 50%)

2. % reduction in neonatal mortality from 45/1000 live births to 40.5/1000 live births (10% reduction)

8.0 Quantitative Performance Evaluation

This study will focus on the content of the intervention, how and to what extent it will be implemented, and what it will achieve. A performance evaluation can complement an evaluation of causal impact in several important ways, (Stern, E et al 2012) it can (1) elucidate how and why an intervention works, (2) distinguish between design and implementation failure if an intervention does not lead to the anticipated effects, (3) provide information for intervention replication in other settings through detailed description of implementation processes and context (Khagram S, Thomas C 2010)

8.1 Quality assessment

The quality of the identified trials centers will be assessed on the basis of the methods used for sampling and for allocation into intervention and control groups. (Higgins JPT, Green S, Eds 2006) Randomization will be classified as: (a) adequate, (b) unclear, (c) inadequate and (d) not used; allocation concealment as: (a) adequate, (b) unclear, (c) inadequate and (d) not used.

9.       Data collection

Data will be quantitative, and collected at each visit that is after 2 months. And the data required during home visits and ANC visits include

Important data to be collected at household level include

                                                               i.      Geographical location

                                                             ii.      Age

                                                            iii.      Number of home visits made

                                                           iv.      Type of intervention carried out – counseling or referrals etc.

Data collected at the health centers

                                                             v.      Screening results

                                                           vi.      Geographical location / origin/age

                                                          vii.      Number of visits made and scheduled next visits

                                                        viii.      Estimated gestation period

                                                           ix.      Risk assessment

9.1 Data analysis

Baseline characteristics of villages and of participating women will be described using counts and percentages for categorical data and mean and standard deviation (symmetrical distribution) or median and inter-quartile range (skewed distribution) for numerical data. Baseline data will be compared between intervention and control groups to identify potential confounders.

The main outcome measures (% women with 4 ANC visits; newborn mortality) will be compared between intervention and control groups using Chi-square and Fisher’s exact test. In case confounding is detected, multiple logistic regression analyses will be used to adjust for confounders. Data analysis will be adjusted for the cluster sampling approach.

For quantitative data analysis, SPSS (statistical package for social scientists) shall be used to analyze data. Important information like number of visits shall be analyzed to see to what extent the home visits helped to increase the ANC visits in the intervention area compared to the control areas. Again the data on the intervention area shall be kept to monitor newborn health to see if there are no further complications .This helps to collate whether the number of ANC visits have a bearing influence on the newborn health.

Statistics will hence help to ascertain if home visits to promote ANC can lead to increase in ANC visits up to four or more and further lead to newborn health.

The following will be the  independent variables: district, number of household members, sequence of pregnancy, marital status, mother's age group , number of ANC visits, trimester during which the first ANC visit was undertaken, receiving care from a healthcare provider during the pregnancy,.

10.  Time frame

The recruitment of pregnant women will take one week. Each CHCW shall be tasked with identifying 14 pregnant women in one week and that means during the week, they need to identify at least 2 pregnant women per day. The same pregnant women identified after applying the inclusion and exclusion criteria shall then be followed up till the eleventh months of the project duration. Then data collection will be from the fifth week till the end of the project.

Months

Activity

1

2

3

4

5

6

7

8

9

10

11

Finalize project and submit

Obtain ethical clearance

Design data collection tools

Secure funds for the project

Printing of data collection tools

Identification and selection  of CHCW

Training of CHCW

Pretest of data collection tools

Identify study participants

Deploying of CHCW for data collection

Home visits / data collection

Data collection at health centers

Post-delivery assessment of newborn health

Data entry and screaming

Data analysis

Report writing and preliminary feedback

Dissemination of  preliminary findings

11.   Ethical considerations

A written consent shall be secured at the time of enrolment of prenatal women into the community intervention study. The pre-enrolment consent detailed, home visits by CHCW and women’s participation in subsequent interviews. During this study women will be reminded of their prior consent to participate in the study and verbal consent to be obtained before conducting interviews.  Should any participant opt to discontinue being part of the intervention at any stage, reasons should be taken and the CHCW reports to the supervisory at the ANC health center. All pregnant women that will be approached for the interviews shall have to first accept to participate and if a pregnant woman decides not to participate in the study her decision should be respected and CHCW shall not include her in the study and for confidentiality the matter remains there and not to be reported or recorded as having refused . Confidentiality also applies to the data and interaction of the pregnant women and CHCW and the ANC personnel. All CHCW will provide verbal consent to participate in this study. Confidentiality will be maintained throughout the interviews and results will be anonymous to protect identity. This study will also seek approval from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health, College of Health Sciences and the National Council of Science and Technology in Uganda. The Bushenyi district Health officer will be approached to offer approval of the study in the area.

12.   Limitations of the study

Pregnancy, childbirth and the newborn period is surrounded by many cultural beliefs and traditional practices that could serve as a barrier to CHCW work.  For example women who are pregnant are always skeptical of being identified in early stages hence they tend to hide till the pregnancy comes out, this is because of the fear of witchcraft. However, they will be sensitized on the benefits and this could impel mothers to come and participate in the study. The lack of success in identifying pregnancies among high-risk groups of older and younger women points to the need for CHCWs to not only rely on house to house visits, but on other forms of community mobilization and awareness on services available for families expecting a newborn.

The project area is mountainous hence transport may be a problem which may leave many women UN identified for the study. Therefore the home visits may be a problem and the CHCW may not be able to offer at least 4 home visits to a family with a pregnant women. However selecting CHCW from their home villages can reduce on this problem.

These interventions, that use community members as volunteers, have different implementation frameworks and support mechanisms for volunteers and ways of engaging communities. As a result, CHCWs may be faced with demands for material support from families which may have received such support from previous studies. But clarity on the objectives of the study to the community members should be able to curb on this.

In addition, CHCWs may be viewed as fellow community members with limited expertise to teach about health matters. Specific households in the community regarded as having high status, such as politicians, rich households, and homes of health personnel, may under look the CHCW home visits.

The study relies on the knowledge, attitudes, and perceptions of CHCWs, mothers, health workers, and key stakeholders because it is difficult to monitor the content of the care and information provided by CHCW since not all of them can be supervised during home visits, but the training provided should be enough to make all CHCW at the same level of expertise.

Selection bias may also be a limitation because the western region where Bushenyi is located has a higher fertility rate than the eastern and northern hence the study outcomes may not be similar if applied to the other parts of the country.

The study relies on the accuracy of the information collected by the CHCW during home visits and the quality of ANC provided by the health centers designated. because poor ANC services may not result in positive newborn health even if all the four ANC visits or more are completed putting into consideration that most health centers that offer ANC have problems with ANC related care and drugs which are either insufficient or not present . Moses T (2012) observed that in Uganda,” the ANC services are characterized by poor attendance, poor counseling services and poor client-provider relations, with the quality being worse in rural areas “ 

The main confounders the pregnant women may not adhere to the home visits if at all its may be a planting season. Hence home visits and ANC may be compromised for their usual livelihood means. However this shall be communicated and a better time before or after their routine daily activities can be designated for home visits. Confounders identified will be adjusted during multivariable analysis.

13.   Implications for future research

The following gaps in the study , there is need to further ascertain the roles of CHCW home visits and their  (i) the effectiveness of the intervention package in low-mortality settings in other regions, particularly sub-Saharan Africa; (ii) the effectiveness of the intervention package in settings with lower neonatal mortality rates (15–29 deaths per 1000 live births (iii) the benefit of adding a curative component (especially the treatment of neonatal sepsis) to preventive or promotive neonatal care; (iv) the relative efficacy of home visits of a certain number and timing (e.g. 1 versus 2–3 in the first week of life); and (v) ways to achieve high coverage and an intervention of high quality in program settings.

Given issues around CHCW confidence, the optimal duration of training and intervals for refresher training and/or on-the-job mentorship needs to be further established.

References

1.       Ahorlu, C,K.,Koram, K,A., Seakey, A,K., et al (2009). Effectiveness of combined intermittent preventive treatment for children and timely home treatment for malaria control. Malaria Journal. 2009;8:292. [PMC free article] [PubMed]

2.       Bang, A,T., Bang, R., Baitule, S., Reddy, M., andDeshmukh, M.(1999). Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet. 1999;354:1955–1961. doi: 10.1016/S0140-6736(99)03046-9. [PubMed] [Cross Ref]

3.       Bhandari, N., Mazumder, S., Taneja, S., et al (2012). Effect of implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI) programme on neonatal and infant mortality: cluster randomized controlled trial. BMJ. 2012;344:e1634. doi: 10.1136/bmj.e1634. [PMC free article] [PubMed] [Cross Ref]

4.       Bhutta, Z,A., Memon, Z,A., Soofi, S., et al (2008). Implementing community–based perinatal care: results from a pilot study in rural Pakistan. Bull World Health Organ. 2008;86:452–9. doi: 10.2471/BLT.07.045849. [PMC free article] [PubMed] [Cross Ref]

5.       Brenner, J,L., Kabakyenga, J., Kyomuhangi, T. et al.(2011). Can volunteer community health workers decrease child morbidity and mortality in southwestern Uganda? An impact evaluation. PLoS One. 2011; 6(12):e27997. | Publisher Full Text

6.       Bushenyidistrict Uganda. (2012). Health Facilities Assessment Report .available on http://www.starelqas.ug/wp-content/uploads/Bushenyi-HFA-Report.pdf. accessed on 4th September 2015

7.       Darmstadt, G,L., Bhutta, Z,A., Cousens, S.et al (2005). Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005;365(9463):977–988. [PubMed].

8.       Finlayson, K., and Downe, S. (2013). Why do women not use antenatal services in low- and middle-income countries? A meta-synthesis of qualitative studies. PLoS Medicine 10: e1001373.

9.       Gogia, S., and Sachdev, H,S. (2010) .Home visits by community health workers to prevent neonatal deaths in developing countries: a systematic review. Bull World Health Organ. 2010;88(9):658–666. doi: 10.2471/BLT.09.069369. [PMC free article] [PubMed] [Cross Ref.

10.   Hsieh, H,F.,andShannon, S,E. (2005). Three approaches to qualitative content analysis. Qual Health Res. 2005; 15(9):1277-88. | Publisher Full Text

11.   Khagram, S., Thomas, C. et al (2010). Toward a platinum standard for evidence-based assessment by 2020. Public Adm Rev. 2010;70: pp100–106.

12.   Kirkwood, B,R., Manu, A., Asbroek, T,H. et al. ( 2013). Effect of the Newhints home–visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomized controlled trial. Lancet. 2013;doi: 10.1016/S0140-6736(13)60095-1. [PubMed] pp 381-392

13.   Kumar, V., Mohanty, S., Kumar, A. et al.(2008). Effect of community-based behavior change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomized controlled trial. Lancet 2008; 372: 1151–62. PubMed | Publisher Full Text

14.   Lassi, Z,S., Haider, B,A., Bhutta, Z,A. et al (2010).Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes. Cochrane Database Syst Rev 2010, 11(11):CD007754.

15.   Lawn, J,E., Blencowe, H., Pattinson, R., et al (2011): Stillbirths: Where? When? Why? How to make the data count? Lancet 2011, 377(9775):1448-1463. PubMed | Publisher Full Text

16.   le Roux, I,M., Tomlinson, M., Harwood, J,M., et al (2013). Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial. AIDS. 2013;27: pp1461–1471. [PMC free article] [PubMed]

17.   Lehmann, U., Sanders, D. et al (2007). Community health workers: What do we know about them? The state of evidence on programs, activities, costs and impact on health outcomes of using community health workers. Geneva: World Health Organization: Evidence and Information for Policy; 2007.

18.   Lewycka, S., Mwansambo, C., Rosato, M. et al (2013). Effect of women’s groups and volunteer peer counseling on rates of mortality, morbidity, and health behaviors in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomized controlled trial. Lancet. 2013;381(9879):pp1721–1735. [PMC free article] [PubMed]

19.   Līga, T., Gaetano ,S., Elizabeth, E., and Peter, W.(2015) Strategies for helping families prepare for birth: experiences from eastern central Uganda. Glob Health Action. 2015 (PubMed) pp 4

20.   MangwiAyiasi, R., Kasasa, S., et al (2014) Is antenatal care preparing mothers to care for their newborns? A community-based cross-sectional study among lactating women in Masindi, Uganda. BMC Pregnancy Childbirth. 2014; 14:114 pp44. PubMed  | BioMed Central Full Text

21.   Ministry of Health and Makerere University School of Public Health (MOH/MUSPH) (2012). Uganda Health System Assessment 2011. Kampala, Uganda and Bethesda, MD: Health Systems 20/20 project, Abt Associates Inc. pp 44

22.  Moses,Tetui. (2012).Quality of Antenatal care services in eastern Uganda: implications for interventions. PubMed PMCID: PMC3527020

23.   O'Riordan M.(2014) Use of Non-docs Improves Adherence Following ACS. World Congress of Cardiology (WCC) Scientific Sessions 2014. Melbourne, Australia: 2014.

24.   Penfold, S., Manzi, F., Mkumbo, E, et al (2014).  Effect of home–based counseling on newborn care practices in southern Tanzania one year after implementation: a cluster–randomized controlled trial. BMC Pediatr. 2014;14:187. doi: 10.1186/1471-2431-14-187. [PMC free article]

25.   Perry, H., Freeman, P., Gupta, S., Rassekh, B,M,. et al (2009).How Effective is Community-based Primary Health Care in Improving the Health of Children? Summary Findings of a Review of the Evidence and Report to the Expert Review Panel. Washington DC: Working Group on Community-based Primary Health Care, International Health Section, American Public Health Association; 2009.

26.   Satterfield, D., Burd, C., Valdez, L., et al(2002). The “in-between people”: participation of community health representatives in diabetes prevention and care in American Indian and Alaska native communities. Health PromotPract. 2002;3: pp166–175.

27.   Seung-Ah,Choe.,Jinseob, Kim., Saerom, Kim., et al (2015). Do antenatal care visits always contribute to facility-based delivery in Tanzania? A study of repeated cross-sectional data. Department of Preventive Medicine Korea and Good Neighbors International Tanzania, Muanza, Tanzania pp 5-8

28.   Stern, E., Stame, N., Mayne, J., et al(2012). Broadening the Range of Designs and Methods for Impact Evaluations. London: DFID; 2012

29.   Sterne, J,A,C., Egger, M., Smith, G,D. et al (2001).Investigating and dealing with publication and other biases. In: Egger M, Smith GD, Altman DG, editors. Systematic reviews in health care: meta-analysis in context. London: BMJ Books; 2001. pp. 189-208

30.   Tough, S,C., Johnston, D,W., Siever, J,E., et al(2006). Does supplementary prenatal nursing and home visitation support improve resource use in a universal health care system? A randomized controlled trial in Canada. Birth. 2006;33:pp183–194. [PubMed]

31.   Tylleskar, T., Jackson, D., Meda, N., et al.(2011).  Exclusive breastfeeding promotion by peer counselors in sub-Saharan Africa (PROMISE-EBF): a cluster-randomized trial. Lancet. 2011; 378(9789):420-7. PubMed  | Publisher Full Text

32.   Uganda Bureau of Statistics (UBOS) (2007)Uganda Demographic and Health Survey 2006. Calverton, MD: UBOS and Macro International Inc.; 2007.

33.   UNICEF (2013)country statistics Uganda 2013.  Available on http://www.unicef.org/infobycountry/uganda_statistics.html  accessed September 2 2015

34.   Van Belle, S,B., Marshal, B., Dubourg, D., et a (2010).How to develop a theory-driven evaluation design? Lessons learned from an adolescent sexual and reproductive health programme in West Africa. BMC Public Health. 2010;10:741. [PMC free article] [PubMed]

35.   Waiswa, P., Peterson, S., Namazzi, G., et al(2012). The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities – study protocol for a cluster randomized controlled trial. Trials 2012; 13: 213. PubMed Central Full Text

36.   WHO (2014). Global health observatory data repository. 2014. Available at: http://apps.who.int/gho/data/view.main.1610?lang=en. Accessed August 27 2015.

37.   WHO, UNICEF, UNFPA, The World Bank(2010)Trends in maternal mortality: 1990 to 2008. Geneva: World Health Organization; 2010. http://whqlibdoc.who.int/publications/2010/9789241500265_eng.pdfwebsite

38.   World Health Organization  (2003). Antenatal Care in Developing Countries—Promises, Achievements and Missed Opportunities. Geneva, Switzerland: WHO; 2003.

39.   World Health Organization(2014).Recommendations on postnatal care of the mother and newborn. Geneva: WHO, 2013. Available at: http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf. Accessed: 1 September, 2015.

40.   Zelen, M.(1990).Randomized consent designs for clinical trials , an update PubMed pp 645-645

Appendix 1.Summary of the articles identified for review

Author and year	Article	Purpose	Sample setting	Research methods	Key findings	Conclusions	Quality / limitations
Kirkwood BR, Manu A, ten Asbroek AH(2013)	Effect of the Newhints home–visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomized controlled trial	Identify the effects of home visits by CHCW on Neonatal mortality	The CBSVs in the study zones were trained to identify pregnant women in their community and to make two home visits during pregnancy.	a cluster randomized controlled trial.	The intervention achieved a reduction of 8% in the overall neonatal mortality rate	CHCW ANC home visits can reduce neonatal mortality	Other preventive measures like breast feeding and warming the baby  may contribute to reduction in neonatal mortality.
Seung-Ah Choe, Jinseob Kim, Saerom Kim, et al 2015	Do antenatal care visits always contribute to facility-based delivery in Tanzania?	conducted in to explore the relationship between antenatal care (ANC) visits by CHCW , facility-based delivery and the reasons for home births in women who had made ANC visits	data from RCS Demographic and Health Surveys spanning 20 years and a cluster sample of 30 830 women from 52 districts of Tanzania. T	repeated cross-sectional study  (RCS) data from Tanzania to explore the relationship between antenatal care (ANC) visits, facility-based delivery and the reasons for home births in women who had made ANC visits.	Between 1991 and 2010, the national proportion of women who had more than four ANC visits during their last pregnancy had decreased from 56.1% to 33.3 . In the same period, there was a decreasing trend in facility delivery followed by a relatively modest increase in the latter timeframe (50.3% in 1991– 92, 38.4% in 1999 and 45.1% in 2009–10	Increase of ANC visits >  2–4 times was associated with higher facility delivery rate only in urban area. The proportion of at least four ANC visits was not related to facility de- livery rates at the district level in rural Tanzania.	The ANC visits and increase in home deliveries may be applicable in Urban areas but not in Rural areas
Penfold S, Manzi F, MkumboE at al 2014	Effect of home–based counseling on newborn care practices in southern Tanzania	to improve newborn care practices and survival.	All 132 wards in the 6-district study area were randomized to intervention or comparison groups. Starting in 2010, in intervention areas trained volunteers made home visits. In 2011, in a representative sample of 5,240 households,	a cluster-randomized trial in six districts of Southern Tanzania. Baseline data collected in five of those six districts in 2007 estimated the neonatal mortality rate at 34 per 1,000 live births (unpublished data).	Four of 14 newborn care practices were more commonly reported in intervention than comparison areas: delaying the baby’s first bath by at least six hours (81% versus 68%, OR 2.0 (95% CI 1.2-3.4)), exclusive breastfeeding in the three days after birth (83% versus 71%, OR 1.9 (95% CI 1.3-2.9)), putting nothing on the cord (87% versus 70%, OR 2.8 (95% CI 1.7-4.6)), and, for home births, tying the cord with a clean thread (69% versus 39%, OR 3.4 (95% CI 1.5-7.5)). For other behaviors there was little evidence of differences in reported practices between intervention and comparison	A home-based counseling strategy using volunteers and designed for scale-up can improve newborn care behaviors in rural communities of southern Tanzania.	Further research is needed to evaluate if, and at what cost, these gains will lead to improved newborn survival. . the length of the study may have led to interference of other factors or players in improving neonatal care practices
Bhandari N, Mazumder S, Taneja et al 2012	. Effect of implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI) programme on neonatal and infant mortality	To evaluate the Indian Integrated Management of Neonatal and Childhood Illness (IMNCI) programme, which integrates improved treatment of illness for children with home visits for newborn care, to inform its scale-up?	8 clusters (population 1.1 million) in Haryana, India. 29,667 births in intervention clusters and 30,813 in control clusters.	Randomized control trial in 8 clusters to evaluate management of neonatal illness by Home visits	The infant mortality rate and the neonatal mortality rate were significantly lower in the intervention clusters than in control clusters.	Implementation of the IMNCI resulted in substantial improvement in infant survival and in neonatal survival in those born at home. The IMNCI should be a part of India's strategy to achieve the millennium development goal on child survival	Depending on the population of India , and other high risk areas where literacy may be low , the results could be different
Bhutta ZA, Memon ZA, Soofi S et al 2008	Implementing community–based perinatal care: results from a pilot study in rural Pakistan. Bull World Health Organ.	This pilot study investigated the feasibility of delivering a package of community-based interventions for improving perinatal care using lady health workers (LHWs) and traditional birth attendants (Dais) in rural Pakistan.	The intervention was implemented in four of eight village clusters (315 villages, total population 138 600), while four served as a comparison group	Cluster randomized  trial	In intervention villages, there were significant reductions from baseline in stillbirth (from 65.9 to 43.1 per 1000 births, P < 0.001) and neonatal mortality rates (from 57.3 to 41.3 per 1000 live births, P < 0.001). The proportion of deliveries conducted by skilled attendants at public sector facilities also increased, from 18% at baseline to 30%, while the proportion of home births decreased from 79% to 65%.	The improved stillbirth and neonatal mortality rates observed indicate that community health workers (i.e. LHWs and Dais) can be effective in implementing a community and outreach package that leads to improved home care practices by families, increased care-seeking behavior and greater utilization of skilled care providers	The use of CHCW and traditional birth attendants may interfere in the results and one cannot determine which group contributed to the neonatal rates
Kumar V, Mohanty S, Kumar A, Misra RP, Santosham M, Awasthi S, et al 2008	Effect of community-based behavior change management on neonatal mortality in Shivgarh, Uttar Pradesh, India	aimed at modifying practices and reducing neonatal mortality	39 village administrative units (population 104,123) were allocated to one of three groups: a control group, which received the usual services of governmental and non-governmental organizations in the area; an intervention group, which received a preventive package of interventions for essential newborn care	a cluster-randomized controlled efficacy trial in Shivgarh, a rural area in Uttar Pradesh clusters, community health workers delivered the packages via collective meetings and two antenatal and two postnatal household visitation	neonatal mortality rate was reduced by 54% in the essential newborn-care intervention) and by 52% in the essential newborn care	A socio-culturally contextualized, community-based intervention, targeted at high-risk newborn-care practices, can lead to substantial behavioral modification and reduction in neonatal mortality. This approach can be applied to behavior change along the continuum of care, harmonies vertical interventions, and build community capacity	There was little change in care-seeking. Compared with controls, which may mean the two arms may not have been well controlled in the study
Waiswa P, Peterson SS, Namazzi G, et al 2012	The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities – study	To adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda.	in 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHCWs to visit the mother five times in her home during pregnancy and the neonatal period	a two-arm cluster randomized controlled design with both areas benefit from a standardized strengthening of facility care for mothers and neonates.	home visits by trained CHCWs to promote preventive care as well as to provide curative care reduced neonatal mortality by about 30%	CHCW can be effective in improvement of newborn health if home visits are increased and well supervised	Another limitation is that the study was implemented in a small area where the risk of contamination is high
Bang AT, Bang R, Baitule et al 1999	Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India	Investigate CHCW home visits and the outcome on neonatal mortality	3 communities in high mortality areas were identified for Home visits by CHCW	Field trial  in rural India	home visits can reduce deaths of newborns in high-mortality, developing country settings by 30 to 61	The visits led to  improved coverage of key newborn care practices such as early initiation of breastfeeding, exclusive breastfeeding, skin-to-skin contact, delayed bathing and attention to hygiene, such as hand washing with soap and water, and clean umbilical cord care.	the limitations are , the study was conducted in high neonatal mortality areas and results may be different on low neonatal areas . and the two control arms may have been tampered with
Tylleskar T, Jackson D, Meda N et al 2011	Exclusive breastfeeding promotion by peer counselors in sub-Saharan Africa (PROMISE-EBF):	Whether ANC peer counseling can improve exclusive breast feeding	24 communities in Burkina Faso, 24 in Uganda, and 34 in South Africa were assigned in a 1:1 ratio, by use of a computer-generated randomization sequence, to the control or intervention clusters. In the intervention group, one antenatal breastfeeding peer counseling visit and four post-delivery visits by trained peers	Cluster randomized trial	antenatal peer counseling by CHCWs improved prevalence of exclusive breastfeeding	Low-intensity individual breastfeeding peer counseling is achievable and, although it does not affect the diarrhoea prevalence, can be used to effectively increase EBF prevalence in many sub-Saharan African settings.	The study did not first measure the literacy levels of the women selected since due to their exposure to education , they may already be aware of exclusive breast feeding . the heterogeneity of the selected people in 3 different countries was not considered
Brenner JL, Kabakyenga J, Kyomuhangi et al 2011	Can volunteer community health workers decrease child morbidity and mortality in southwestern Uganda	to assess volunteer community health workers' effect on child morbidity, mortality and to calculate volunteer retention.	Two volunteer community health workers were selected, trained and promoted child health in each of 116 villages (population ~61,000) during 2006–2009.	Impact evaluations survey	Post-intervention surveys in intervention households revealed absolute reductions of 10.2%  in diarrhea prevalence and 5.8% in fever/malaria; comparative decreases in control households were not statistically significant. Underweight prevalence was reduced by 5.1% in intervention households. a relative decline of 53% in child deaths (<5 years old), during the first 18 months of intervention	A low-cost child health promotion model using volunteer community health workers demonstrated decreased child morbidity, dramatic mortality trend declines and high volunteer retention.	The sample size may have been too big to monitor and supervision of the home visits may be difficult .
Gogia S, Sachdev HS 2010	Home visits by community health workers to prevent neonatal deaths in developing countries: a	To determine whether home visits for neonatal care by community health workers can reduce infant and neonatal deaths and stillbirths in resource-limited settings.	Five trials, all from south Asia, satisfied the inclusion criteria. The intervention packages included in them comprised antenatal home visits (all trials), home visits during the neonatal period (all trials), home-based treatment for illness (3 trials) and community mobilization efforts (4 trial	Meta-analysis	Meta-analysis showed a reduced risk of neonatal death  and stillbirth and a significant improvement in antenatal and neonatal practice indicators (> 1 antenatal check-up, 2 doses of maternal tetanus toxoid, clean umbilical cord care, early breastfeeding and delayed bathing). Only one trial recorded infant deaths	Home visits for antenatal and neonatal care, together with community mobilization activities, are associated with reduced neonatal mortality and stillbirths in southern Asian settings with high neonatal mortality and poor access to facility-based health car	data on stillbirths were limited to three trials, while only one trial had investigated infant mortality and cause-specific mortality. Second, all trials were conducted in parts of southern Asia with high baseline neonatal mortality rates (> 45 deaths per 1000 live births), which impedes generalization to other regions, particularly to sub-Saharan Africa or to areas with lower neonatal mortality.
Darmstadt GL, Bhutta ZA, Cousens S, et al 2005	Evidence-based, cost-effective interventions: how many newborn babies can we save? World wide	Identify what  interventions could avert an estimated 41-72% of neonatal deaths worldwide.	16 interventions with proven efficacy (implementation under ideal conditions) for neonatal survival and combine them into packages for scaling up in health systems. three service delivery modes (outreach, family-community, and facility-based clinical care)	Systematic review	Reductions in neonatal mortality that exceed 50% can be achieved with an integrated, high-coverage programme of universal outreach and family-community care, consisting of 12% and 26%, respectively,	Early success in averting neonatal deaths is possible in settings with high mortality and weak health systems through outreach and family-community care, including health education to improve home-care practices, to create demand for skilled care, and to improve care seeking. Simultaneous expansion of clinical care for babies and mothers is essential to achieve the reduction in neonatal deaths	Reviews did not test the hypothesis to confirm the results because other factors other than CHCW and community based interventions may play a part in those results .
Lewycka S, Mwansambo C, Rosato M et al 2013	Effect of women’s groups and volunteer peer counseling on rates of mortality, morbidity, and health behaviors in mothers and children in rural Malawi (MaiMwana):	Women were  assessed on their effects on mortality and breastfeeding rates in rural Malawi	All women aged 10–49 years who consented to participate were enrolled. The 48 clusters were allocated randomly to one of four groups 12 were allocated to the women’s group and volunteer peer counseling, 12 women’s group only, 12 volunteer peer counseling only, and 12 no intervention	cluster-randomized trial in 185 888 people in Mchinjidistrict. 48 equal-sized clusters were randomly allocated to four groups with a computer-generated	results of the stratified, adjusted analysis showed a 36% reduction in IMR  but no effect on EBF in areas without women’s groups, and in areas with women’s groups there was no effect on IMR  and an increase in EBF.	Community mobilization through women’s groups and volunteer peer counselor health education are methods to improve maternal and child health outcomes in poor rural populations in Africa	The study limitations were that since 2004 to 2013 changes and influences may affect the study sample and hence the results .  the sample was also too large to control
Lassi ZS, Haider BA, Bhutta ZA 2010	Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes	To assess the effectiveness of community-based intervention packages in reducing maternal and neonatal morbidity and mortality; and improving neonatal outcomes	review included 18 cluster-randomized/quasi-randomized trials, covering a wide range of interventional packages, including two subsets from one trial.	All prospective randomized and quasi-experimental trials evaluating the effectiveness of community-based intervention packages in reducing maternal and neonatal mortality and morbidities; and improving neonatal outcomes	The  review did not show any reduction in maternal mortality. However, significant reduction was observed in maternal morbidity 28%; neonatal mortality 69%, stillbirths  66%, and prenatal 82%, as a consequence of implementation of community-based interventional care packages. It also increased the referrals to health facility for pregnancy related complication by 40% and improved the rates of early breastfeeding by 94% initiation	The study offers encouraging evidence of the value of integrating maternal and newborn care in community settings through a range of interventions which can be packaged effectively for delivery through a range of community health workers and health promotion groups.	The study had multiple outcomes which some do not conform to this study.