advanced search

<< Back To Home

- - EFFECT OF WOMENS GROUPS AND VOLUNTEER PEER COUNSELLING, RURAL MALAWI

Friday, 17th of May 2013

• EFFECT OF WOMENS GROUPS AND VOLUNTEER PEER COUNSELLING ON RATES OF MORTALITY, MORBIDITY, AND HEALTH BEHAVIOURS IN MOTHERS AND CHILDREN IN RURAL MALAWI (MAIMWANA): A FACTORIAL, CLUSTER-RANDOMISED CONTROLLED TRIAL

The Lancet, Volume 381, Issue 9879, Pages 1721 - 1735, 18 May 2013

 

 

Original Text

Sonia Lewycka PhD a, Charles Mwansambo FRCPCH b, Mikey Rosato PhD a, Peter Kazembe FRCPCH c, Tambosi Phiri MSc d, Andrew Mganga BSc d, Hilda Chapota ENM d, Florida Malamba Dip d, Esther Kainja ENM d, Prof Marie-Louise Newell PhD e, Giulia Greco MSc f, Anni-Maria Pulkki-Brännström PhD a, Jolene Skordis-Worrall PhD a, Stefania Vergnano MRCPCH a, David Osrin PhD a, Prof Anthony Costello FMedSci a

Background

Womens groups and health education by peer counsellors can improve the health of mothers and children. We assessed their effects on mortality and breastfeeding rates in rural Malawi.

Methods

We did a 2×2 factorial, cluster-randomised trial in 185 888 people in Mchinji district. 48 equal-sized clusters were randomly allocated to four groups with a computer-generated number sequence. 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems. 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care. Primary outcomes for the womens group intervention were maternal, perinatal, neonatal, and infant mortality rates (MMR, PMR, NMR, and IMR, respectively); and for the peer counselling were IMR and exclusive breastfeeding (EBF) rates. Analysis was by intention to treat. The trial is registered as ISRCTN06477126.

Findings

We monitored outcomes of 26 262 births between 2005 and 2009. In a factorial model adjusted only for clustering and the volunteer peer counselling intervention, in womens group areas, for years 2 and 3, we noted non-significant decreases in NMR (odds ratio 0·93, 0·64—1·35) and MMR (0·54, 0·28—1·04). After adjustment for parity, socioeconomic quintile, and baseline measures, effects were larger for NMR (0·85, 0·59—1·22) and MMR (0·48, 0·26—0·91). Because of the interaction between the two interventions, a stratified analysis was done. For womens groups, in adjusted analyses, MMR fell by 74% (0·26, 0·10—0·70), and NMR by 41% (0·59, 0·40—0·86) in areas with no peer counsellors, but there was no effect in areas with counsellors (1·09, 0·40—2·98, and 1·38, 0·75—2·54). Factorial analysis for the peer counselling intervention for years 1—3 showed a fall in IMR of 18% (0·82, 0·67—1·00) and an improvement in EBF rates (2·42, 1·48—3·96). The results of the stratified, adjusted analysis showed a 36% reduction in IMR (0·64, 0·48—0·85) but no effect on EBF (1·18, 0·63—2·25) in areas without womens groups, and in areas with womens groups there was no effect on IMR (1·05, 0·82—1·36) and an increase in EBF (5·02, 2·67—9·44). The cost of womens groups was US$114 per year of life lost (YLL) averted and that of peer counsellors was $33 per YLL averted, using stratified data from single intervention comparisons.

Interpretation

Community mobilisation through womens groups and volunteer peer counsellor health education are methods to improve maternal and child health outcomes in poor rural populations in Africa.

Funding

Saving Newborn Lives, UK Department for International Development, and Wellcome Trust.

Worldwide, the mortality rate in children younger than 5 years is still unacceptably high at 7·7 million to 8·8 million per year, and includes 3·6 million deaths in newborn babies.1, 2 In Malawi, the mortality rate in children younger than 5 years during 2005—10 was 112 per 1000 livebirths, of which 30% were neonates.1, 3 In south Asia, community mobilisation through womens groups reduced the rate of neonatal mortality, probably through improved solidarity, decision making, preventive care, care-seeking, and health-service accountability.4, 5

Exclusive breastfeeding helps development of the immune system,6 improves survival of children born to HIV-infected mothers,7 and reduces the risk of mother-to-child transmission (MTCT) of HIV compared with mixed feeding.7, 8 The findings from systematic reviews9, 10 suggest that peer advice and support for mothers improve hygiene, recognition of illness in infants, and breastfeeding. Evidence that exclusive breastfeeding as a result of peer counselling leads to a reduction in the mortality rate is scarce. The results of research suggest that peer counselling increases the rates of breastfeeding and reduces those of diarrhoea, with little effect on mortality rates.11—17 According to the findings of a Cochrane review,10 further trials are needed to assess the cost-effectiveness of lay and professional support for breastfeeding.

Most births in African countries occur at home, especially in rural areas, and many deaths in infants might be prevented if mothers are given advice about feeding, infant care, danger signs, MTCT, HIV testing and treatment, and care-seeking. In Africa, no trials of community mobilisation through womens groups, and only one trial of counselling for exclusive breastfeeding, have been done to assess effects on child mortality. The effects of community mobilisation through womens groups, and health education through female volunteer peer counsellors on rates of infant care, feeding, morbidity, and mortality were assessed in the MaiMwana Project, a collaboration between the Malawi Ministry of Health and University College London, London, UK.

Study location and population

90% of Malawis population live on less than US$2 a day.18 Mchinji district, in the central region, has a population of 455 000, of which 90% live in rural areas and are dependent on subsistence farming.19 In 2006, 99% of women in this district attended antenatal care at least once during pregnancy and 58% delivered at a health facility.20 Health care is provided by one district hospital, four rural hospitals, nine health centres, and private clinics. Quality is compromised by a severe shortage of personnel, low morale, and irregular drug supplies.

Participants

A cohort of 43 719 women of childbearing age was defined in 2004 during a baseline household survey. All women aged 10—49 years who consented to participate were enrolled. Cohort members were entered in an open master list to which new participants were added if they moved into the study area. Womens migrations within and outside the study area were recorded to allow for both intention-to-treat and per-protocol analyses.21 Women who had terminal family planning procedures were enumerated but excluded from the final sample. They were not excluded from participating in the interventions.

The study was approved by the Malawi National Health Sciences Research Committee in January, 2003, and the ethics committee of the University College London Institute of Child Health and Great Ormond Street Hospital, London, UK.

Written consent for the random allocation of interventions to communities was obtained from the district commissioner, district health officer, and leaders of participating communities. Most women enrolled were not literate, and verbal consent was obtained for each data gathering episode after explaining the purpose of the visit. Women were free to decline to be interviewed at any time.

Randomisation and masking

We did a cluster-randomised controlled trial using a 2×2 factorial design to assess the effects of two interventions on specific outcome indicators. The study design has been described in detail elsewhere.21 48 clusters were defined on the basis of census enumeration areas (appendix p 1). Each cluster had a population of about 3000 people, with a surrounding buffer area to reduce contamination between intervention and control areas; villages in the buffer area were excluded. Clusters of villages, rather than individual villages, were used as the unit of randomisation to further reduce rates of travel across cluster boundaries and the possibility of contamination. The urban district administrative centre was excluded.

The 48 clusters were allocated randomly to one of four groups (appendix p 1). 12 were allocated to the womens group and volunteer peer counselling, 12 womens group only, 12 volunteer peer counselling only, and 12 no intervention. SL and DO allocated clusters with a random number sequence generated in Stata (version 7.0). Neither was involved in the implementation of the interventions. Although the interventions made masking of allocation impossible at the participant level, allocation was masked for data analysis. Data were gathered independently of programme implementation and could not be used to inform the implementation of the interventions, and thus bias them.

Surveillance

From December, 2004, to December, 2010, each cohort member was visited once a month by a cluster enumerator and data were gathered; the interventions are still in progress, with data (not related to this trial) being gathered. All pregnancies, births, and neonatal, infant, and maternal deaths were identified, and surviving mothers and infants were followed up to 1 year. Trained interviewers administered questionnaires about the demographic characteristics, maternity history, care and care-seeking, and maternal and infant morbidity at 1 month and 6 months after delivery. Feeding practices were ascertained through 24 h and 7 day recall at both interviews. Deaths were verified by a supervisor, through a verbal autopsy interview 2—6 weeks later. When respondents were temporarily unavailable, they were followed up by the interviewers until an outcome was ascertained. If respondents were permanently unavailable, information about dates and timings of events was sought from other community members.

Womens group intervention

From May, 2005, 207 womens groups were established. Each was supported by a cluster facilitator through a community mobilisation action cycle of 20 meetings in four phases (appendix p 2), adapted from cycles used in Bolivia and Nepal.4,22—24 Facilitators (n=24) were local women aged 20—49 years, literate and with at least one child, selected from the community. They were trained over 11 days, with refresher training every 4 months. The facilitators were paid a salary, and given a bicycle, T-shirt, umbrella, field bag, and monitoring forms. They were supported by four supervisors who visited them at least twice a month, observed meetings, and provided training and feedback. The facilitators used a manual to implement the cycle, with participatory rural appraisal methods and picture cards of maternal and newborn health problems to guide discussion. Through the four phases of the cycle, members identified and prioritised maternal and child health problems, identified strategies to implement, planned and implemented them, and assessed them and made plans for the future. Criteria for membership were decided by the groups. Initially restricted to women (phases 1 and 2), membership was expanded to include men (phase 3). More than 12 000 people attended at least once.

Volunteer peer counselling intervention

From December, 2004, 72 female volunteer peer counsellors (two to four per cluster) implemented the intervention.25 Counsellors were selected with communities, and were literate women aged 23—50 years with breastfeeding experience. They identified pregnant women and made five home visits during and after pregnancy: in the third trimester, in the week after birth, and at 1 month, 3 months, and 5 months (appendix p 3). They provided health education about exclusive breastfeeding, infant care, immunisations, prevention of MTCT (PMTCT), and family planning. They also supported women with breast problems and raised awareness of timely care-seeking. Counsellors used an intervention manual describing visit content, and a simple picture book (adapted from manuals published by WHO,26 Save the Children,27 and Linkages28). They were given an initial 5 day and annual refresher training, and attended monthly meetings. They were also given a bicycle, meeting allowances, registers, calendars, and supervision forms. Peer counsellors lived in the same communities, so informal contacts to make arrangements for visits were common. Because the content was time dependent (eg, birth preparedness, immunisations, and weaning), counsellors stopped trying to arrange missed counselling visits after the appropriate time had elapsed, but would still attempt to make the next scheduled visit. No prespecified number of attempted visits were made before giving up. Counsellors only stopped attempting meetings if a woman expressed a lack of interest or refused. If a woman was not identified during pregnancy, counsellors would try to enrol her after delivery to attend the remaining four visits. Reasons for missed visits or discontinued counselling were recorded in their register.

To promote sustainability, planning, and management, the Mchinji district health office was involved. Counsellors were supervised by 24 government health surveillance assistants, who visited quarterly, documenting progress, achievements, and challenges, and by three MaiMwana officers. Health surveillance assistants received initial and yearly refresher training, attended monthly and quarterly meetings, and were given calendars and a supervisory checklist.

Health service inputs

All study clusters benefited from strengthening of health services. Health workers from every facility were trained in essential newborn care, lifesaving skills and safe motherhood, and discussed the MaiMwana interventions. Bulb syringes, resuscitation tables, ambubags, artery forceps, cord clamps, and sphygmomanometers were donated by University College London and UNICEF to all facilities. MaiMwana project and district health staff, with funding from UNICEF, introduced PMTCT to the district in 2005 and all health facilities were covered by 2008.

Outcomes

Primary outcomes were maternal, perinatal, neonatal, and infant mortality rates (MMR, PMR, NMR, and IMR, respectively) for the clusters assigned to the womens group intervention; and IMR and rates of exclusive breastfeeding (EBF) in the first 6 months for those assigned to the volunteer peer counselling intervention (panel 1). PMR was reported as deaths per 1000 births (perinatal), NMR and IMR were reported as deaths per 1000 livebirths, and MMR was reported as deaths per 100 000 livebirths.

Panel 1

Definitions of primary outcomes

• Perinatal death: stillbirth after 28 weeks of gestation, or death of a liveborn infant within 7 completed days of birth
• Neonatal death: death of a liveborn infant within 28 completed days of birth
• Early neonatal death: death arising within 7 completed days of birth
• Late neonatal death: death arising after 7 days but within 28 completed days of birth
• Infant death: death arising within the first year of life
• Maternal death: death of a woman while pregnant or within 42 days of cessation of the pregnancy from any cause related to the pregnancy or its management, but not from accidental causes
• Exclusive breastfeeding: infants receiving only breastmilk and no prelacteal feeds or other liquids or solids except for vitamins, minerals, or medicines

Secondary outcomes for the womens group intervention were maternal and infant morbidity, skilled antenatal, delivery, and postnatal care, tetanus toxoid immunisation, use of malaria prophylaxis, insecticide-treated bednets during pregnancy, and PMTCT services, infant immunisations, early EBF, and reduced use of prelacteal feeds. For the volunteer peer counselling intervention, neonatal mortality and infant morbidity rates were secondary outcomes, and caretaker practices included duration of EBF, time to initiating breastfeeding, use of prelacteal feeds, time to weaning, management of breast problems, and family planning uptake, including condom use. We excluded dietary recall data if they were incomplete or gathered more than 2 weeks after expected interview dates. Care-seeking behaviour included awareness and use of PMTCT and HIV testing services and uptake of immunisations (three doses of pentavalent immunisation and four doses of polio vaccine by 6 months). Birth preparedness was a prespecified outcome assessed indirectly through reported handwashing or use of gloves at delivery and early wrapping of the newborn baby. Use of nevirapine, expressing breastmilk, and infant growth were also prespecified, but data for these outcomes were gathered through different systems and will be investigated in future analyses. Uptake of antenatal, skilled delivery, and postnatal care were included as post-hoc outcomes because they were promoted by peer counsellors. Data for recognition of danger signs, though this was a prespecified secondary outcome for both interventions, were not gathered because showing participants pictures of major danger signs and asking for responses for each would have substantially lengthened the interview.

Statistical analysis

The main analyses were factorial analyses, for comparison of the 24 clusters given the womens group intervention (ie, alone or with volunteer peer counselling) with 24 control clusters (ie, volunteer peer counselling only or no intervention), and the 24 clusters given volunteer peer counselling (ie, alone or with the womens group intervention) with 24 control clusters (ie, womens group alone or no intervention). The volunteer peer counselling intervention was established more rapidly than was the womens group intervention, so the interventions were assessed over different timeframes (appendix p 4). After exclusion of the baseline and establishment periods, the study ran from Feb 1, 2006, to Jan 31, 2009, for the womens group intervention and July 1, 2005, to June 30, 2008, for the volunteer peer counselling intervention.

We did not expect the interventions to have adverse effects at cluster or participant level, and did not institute stopping rules. In October, 2008, we presented preliminary findings to an independent data monitoring committee,29 which recommended further data gathering for 1 year, and consideration of the delays in the first year of the womens group intervention. The committee undertook a final review of the volunteer peer counselling intervention in August, 2009, and of the womens group intervention in March, 2010.

The trial was planned for 3 years, and was powered for an analysis of birth outcomes over 2 years, allowing 1 year for the womens group intervention to be established.21 We assumed a between-cluster coefficient of variation (k) of 0·15—0·30, and about 240 births per cluster in 2 years. A sample size of 24 clusters per comparison group would detect a 47—50% reduction in MMR, 28—33% reduction in PMR, 31—36% reduction in NMR, and 21—28% reduction in IMR between intervention and control areas at 80% power and 5% significance level (assuming baseline mortality rates of 984 per 100 000 livebirths, 34 per 1000 births, 27 per 1000 livebirths, and 76 per 1000 livebirths, respectively).30 At the same power and significance levels, it would detect a 16—30% increase in EBF, assuming baseline levels of 28%.30

Analysis was by intention to treat at cluster and participant levels. Data were excluded from analyses when dates of birth or death were not known. We tested the intervention effect on primary and secondary outcomes on the basis of previously agreed hypotheses. We used multivariate logistic regression with random effects on individual-level data in Stata (version 11.0). Main analyses were factorial and adjusted for clustering, stratification by the other intervention, and socioeconomic and demographic variables. Analyses were adjusted for baseline differences in the womens group intervention, but not in the volunteer peer counselling intervention because this intervention had already started during the 6 month inception and therefore there was a risk of masking early effects. Analysis of year 2 and 3 outcomes was planned because of the potential for delayed effects of the womens group intervention.4, 5, 31 Treatment group analysis was prespecified to investigate any interaction between the interventions, and interaction terms were included in factorial models to assess the strength of interaction.

Cost-effectiveness analysis

Costs were calculated from July, 2004, to January, 2009, separately for womens groups, peer counselling, health-service strengthening, monitoring and evaluation, and process evaluation. Joint costs were shared. Costs from July, to December, 2004, and costs incurred later on that were necessary for implementation, were classified as start-up and running costs (appendix p 4). Costs were estimated from the perspective of a provider in Malawi Kwacha, inflated to 2010 values with the Malawian consumer price index,32 and converted to US$ on July 2, 2010. Capital costs were converted to yearly costs, assuming constant linear depreciation. Residual assets were deducted from programme costs based on resale value on Jan 31, 2009.

Costs were gathered through project accounting systems, vehicle log-books, and time-allocation interviews. Resource use was assessed retrospectively. Donated resources and other items not captured in the accounting ledger were valued on the basis of best alternative use. Volunteer time was not valued at minimum wage because volunteers received financial allowances and goods, and volunteer work did not replace regular employment. Incremental cost-effectiveness was measured in relation to a do-nothing alternative. Results were calculated as the years of life lost (YLL) component of disability-adjusted life-years (DALYs) with 3% discounting and no age weights. Deaths averted were calculated by subtracting actual from expected numbers and, for infant deaths, by multiplying the difference by the ratio of livebirths (n=9120) to births followed up to 1 year (n=7541). Expected deaths were calculated by use of adjusted odds ratios (ORs) from the stratified analyses to control for individual-level confounding. Maternal YLL averted were calculated from a mean age at death of 28 years.

This study is registered as ISRCTN06477126.

Role of the funding source

The funders had no role in the design of the study, data gathering, analysis, interpretation, or writing up of the findings. SL and AC had full access to all the data and AC had final responsibility for the decision to submit for publication.

The figure shows the trial profile; 48 clusters were randomly assigned equally to interventions—womens group plus volunteer peer counselling, womens group only, volunteer peer counselling only, or no intervention. The mean population per cluster was 3873 (range 3083—4933). Intervention implementation started before the trial periods began. The volunteer peer counselling intervention began on Dec 1, 2004, and the womens group intervention on May 1, 2005. We took the 6 months inception, Jan 1, to June 30, 2005, as a baseline for the womens group intervention, and an establishment period for the volunteer peer counselling intervention. Table 1 shows the characteristics of women and pregnancies in intervention groups in this period. Women in the four groups were similar in age, education, and marital status, with small differences in religious and tribal affiliations between groups, fewer farmers in areas with volunteer peer counselling only, and more primigravidae in areas with womens group intervention only. The 24 clusters with volunteer peer counselling had higher uptake of skilled antenatal, delivery, and postnatal care, HIV testing, and exclusive breastfeeding, compared with clusters without peer counselling during this period, and lower frequencies of perceived maternal and neonatal problems, suggesting early intervention effects, though newborn care practices—early wrapping and initiation of breastfeeding—were lower (table 1). The opposite was true for areas with the womens group intervention—lower delivery and postnatal care, and highest perceived maternal problems than in control areas—though early wrapping and breastfeeding were better (table 1). Clusters with only the womens group intervention had the lowest uptake of antenatal and postnatal care and HIV testing, and higher perceived maternal problems (table 1). Exclusive breastfeeding was highest in areas with both interventions, suggesting early effects of volunteer peer counselling (and not an interaction because the womens group intervention had not begun; table 1).

 

Figure Full-size image (96K) Download to PowerPoint

Trial profile

Data correspond to study period for the womens group intervention because intervention study periods overlap; 26 262 births were followed up (analysis dataset). *Pregnancies reported in monthly registers but not followed up with an interview could also include women who moved away permanently, declined, or were temporarily out of the cluster, reporting errors, or some missed interviews; some pregnancies might have resulted in miscarriage, but the miscarriage was not reported.

Table 1Table image  

Characteristics of identified pregnancies in intervention groups during the inception period

Four womens group facilitators dropped out during the trial and were replaced. Over 3 years in intervention areas, data for coverage were provided by 7815 mothers at 1 month after delivery. 4167 (53%) of these mothers had ever attended a womens group. 2457 (59%) of 4167 had attended groups one to five times, 1267 (30%) six to ten times, and 443 (11%) more than ten times. There was one womens group per 105 women aged 15—49 years and per 440 population.

Eight volunteer counsellors and six health surveillance assistants dropped out during the trial and were replaced. Over 3 years in intervention areas, data for coverage were provided by 8112 mothers at 1 month after delivery, and 4447 (55%) of these said they had received counselling (8612 individual visits). Reports at 6 months after delivery were available for 5513 mothers in intervention areas, and 3582 (65%) of these were given counselling (8715 visits). There was one volunteer counsellor per 305 women aged 15—49 years and per 1291 population.

Table 2 summarises the numbers of births and deaths in each group. Mortality rates were higher in the womens group (with or without volunteer peer counselling) than in the non-womens group (volunteer peer counselling only or no intervention) clusters at inception, and highest in clusters given both interventions (womens group plus volunteer peer counselling). PMR, NMR, and IMR fell consistently over 3 years in areas given the womens group intervention with or without volunteer peer counselling; MMR also fell, with the largest reductions in years 2 and 3 (table 2). Non-womens group clusters did not show a similar pattern (table 2). Generally, IMR was lower in clusters assigned to volunteer peer counselling (alone or with womens groups) than in those assigned to non-volunteer peer counselling (womens groups or no intervention) and was lowest in volunteer peer counselling only clusters throughout the study.

Table 2Table image  

Births, deaths, and mortality rates in intervention groups during 2005—09

Table 3 summarises the analyses of the primary outcomes for the womens group intervention. There was no difference between womens group and no womens group intervention clusters in a factorial model adjusted only for clustering and the presence of volunteer peer counselling intervention. Adjustment for cluster-level baseline values, socioeconomic quintile, and parity lowered the ORs. For years 2 and 3, after exclusion of data from the first year (establishment) of the trial, MMR was reduced by 52% (adjusted OR 0·48, 95% CI 0·26—0·91; table 3). Inclusion of interaction terms in models showed highly significant interactions between the two interventions for almost all primary outcomes, and stratified analyses were done. Strong effects were noted in areas without peer counsellors, with reductions of 33% in PMR, 41% in NMR, 28% in IMR, and 74% in MMR in years 2 and 3 (table 3). No effects were noted in areas with peer counsellors. k for NMR was 0·38 for all clusters and 0·28 for control clusters only, corresponding with intracluster correlation coefficients of 0·00376 and 0·00237, respectively.

Table 3Table image  

Factorial and treatment group analyses of primary outcomes

Analysis of secondary outcomes, after adjustment for cluster-level baseline values, socioeconomic quintile, and parity, showed a 50% increase in uptake of antenatal care, and a 30% reduction in births attended by traditional birth attendants (table 4). Exclusive breastfeeding showed an increase of 74% and complete immunisation at 6 months showed a greater than 2·5 times increase (table 4).

Table 4Table image  

Secondary outcomes in intervention and control clusters for the two interventions (womens groups and volunteer peer counselling)

For the primary outcomes with the volunteer peer counselling intervention, we noted an 18% reduction in IMR compared with control areas during the 3 years of the trial after adjustment for stratification and clustering (table 3). This effect was not significant after adjustment for socioeconomic quintile and parity, and the effect size was not increased when the first year was excluded (table 3). Stratified analysis showed large effects on IMR in areas without womens groups (adjusted OR 0·64, 0·48—0·85), but no effect in areas with womens groups. k for IMR was 0·26 for all clusters and 0·14 for control clusters, corresponding with intracluster correlation coefficients of 0·00385 and 0·00120, respectively. Improvements were also noted in exclusive breastfeeding rates (Table 3, Table 4); however, stratified analysis showed that these effects were not significant in areas without womens groups. k for exclusive breastfeeding was 0·91 for all clusters and 0·62 for control clusters only (intracluster correlation coefficients 0·14703 and 0·04263, respectively).

Analysis of secondary outcomes for the peer counselling intervention, after adjustment for socioeconomic quintile and parity, showed much lower use of prelacteal feeds, shorter mean time to first breastfeed, and higher mean age of starting porridge (the main complimentary feed; table 4). Immunisation rates were already high in all study areas at inception, and though coverage was generally higher in peer counselling areas during the study, only the effect on BCG was significant (table 4), and the number of infants fully vaccinated for poliomyelitis was lower. Reported breastfeeding problems and associated care-seeking did not differ between control and intervention groups, but reported infant cough, fever, or diarrhoea was 42% lower in intervention areas (table 4).

No differences were noted in use of family planning, or other antenatal, delivery, and postnatal care-seeking (table 4). Uptake of HIV testing was much higher in all areas than it was at inception, but there was no difference between volunteer peer counselling and control areas during the study (table 4).

The presence of both interventions in a cluster improved coverage, with 2192 (57%) of 3874 women with available attendance data having ever attended a womens group by 1 month post partum, compared with 1975 (50%) of 3941 in clusters with womens group only. 2552 (63%) of 4055 women with available visit data had ever been visited by a peer counsellor in areas with both interventions, compared with 1895 (47%) of 4057 in areas with only volunteer peer counselling. Despite this, the effects on mortality rates were lower than in areas with one intervention.

Comparisons were made between control areas and the three intervention groups (table 3). Striking effects were noted on MMR with womens groups only, and on IMR with volunteer peer counselling only in years 1—3. Table 2 shows that IMR remained the lowest in peer counselling only areas throughout the study. Outcomes in years 2 and 3 showed striking effects on all mortality rates in areas with womens group intervention only (table 3). With the exception of MMR, adjusted ORs in areas with both interventions were near to 1·00 (table 3). All interaction effects were significant, except for MMR and NMR for model 2, years 1—3, though these treatment group effects showed a similar pattern (table 3). Treatment group analysis of EBF showed much higher rates in double intervention areas than in control areas, and non-significant effects in areas with either intervention alone (table 3). This pattern was the same as at inception, before the womens groups had started, and could not have been due to interaction (table 1).

Significant interactions were not noted for secondary outcomes, though treatment group analysis showed larger effects in areas with both interventions. Adjusted (for clustering, stratification, socioeconomic quintile, parity, and baseline values) ORs for skilled birth attendance were 1·36 (0·89—2·06) for areas with both interventions, 1·21 (0·80—1·83) for womens group only, and 1·10 (0·72—1·67) for volunteer peer counselling only.

The total economic cost of the womens group intervention was $698 459. The cost of the volunteer peer counselling intervention was $263 544. In years 2—3, 48·4 maternal deaths and 157·5 infant deaths were averted by the womens group intervention. In years 1—3, 258·5 infant deaths were averted by the volunteer peer counselling intervention. The cost of the womens groups was $114 per YLL averted (infant and maternal deaths), and was of similar magnitude to other studies.4, 5 The average cost of volunteer peer counselling was $33 per YLL averted.

The mean costs per year were $16·6 per infant (womens group), $6·3 per infant (volunteer peer counselling), and $5·6 per woman of childbearing age (womens group). Health service strengthening added $1·6 and monitoring and assessment $5·4 per woman of childbearing age. $601 019 (86%) of the cost of the womens group and $205 446 (78%) of the cost of the volunteer peer counselling group were for implementation.

Our results suggest that, in rural Malawi, a womens group intervention mobilising communities for improved maternal and child health reduced MMR (74%), PMR (33%), NMR (41%), and IMR (28%) in years 2 and 3, in adjusted, stratified models in areas without a peer counselling intervention, but had no effects in areas with peer counselling. In areas without womens groups, where volunteer peer counsellors advised mothers about feeding and infant care, IMR fell by 36% (table 3), and overall infant morbidity by 42% (table 4). EBF rates increased more than two times, but after stratification the effect was only significant in areas with womens group intervention. Both interventions were highly cost effective, averting 1 YLL for less than the per head gross domestic product of Malawi.33 Despite the lower than expected coverage and attendance, the effect of both interventions was impressive. Increasing coverage would have increased costs, making the interventions difficult to implement on a larger scale. Secondary outcomes suggested changes toward improved care and care-seeking behaviour, though few indicators showed conclusive effects. Reductions in morbidity and mortality rates might have been due to small changes in many behaviours (panel 2).34

Panel 2

Research in context

Systematic review

We searched PubMed and the Cochrane Library for relevant papers published from Jan 1, 2000, to Dec 31, 2011. We also searched key internet sites, including those of UNICEF, WHO, and the World Bank. Search terms were “community participation”, “community mobilisation”, “newborn mortality”, “maternal mortality”, “breastfeeding”, and “peer counsellor”. Searches were restricted to reports published in English. We assessed the quality of the evidence by critically reviewing the methods used in each study and focusing on randomised controlled trials.

Interpretation

The results from our study add to existing evidence because we report, as far as we know, the first population-based trial of a community action cycle for birth outcomes in an African country led by a participatory womens group, and the first trial of the effect of a volunteer peer counselling intervention on infant mortality rates. We compared our results with those of other studies with similar methods that have been done mainly in south Asian countries. Our findings allow us to draw firmer conclusions that womens groups with a community action cycle are a generalisable method for improving survival of newborn babies and mothers in poor rural communities. The work with volunteer counsellors takes forward the evidence that community peer education on infant care and feeding not only improves feeding behaviours but also might have a direct effect on infant mortality. Demand-side interventions are a crucial, yet neglected, component of strategies to improve maternal and child health and to achieve the Millennium Development Goals.

Our study had some limitations. Although surveillance of births and deaths was prospective and quality controlled, errors probably arose in ascertainment and classification of outcomes. Delays in implementation of activities by the womens groups in year 1 diluted the effects noted overall. Breastfeeding status was ascertained by use of self-report at two timepoints, raising the possibility of misclassification. The low exclusive breastfeeding proportion (14%) compared with Malawi Demographic and Health Survey estimates (28%),30 suggests it was not over-reported. Losses to follow-up for breastfeeding outcomes are largely explained by the exclusion of incomplete or delayed dietary recall data. Because women knew their intervention allocation, behavioural answers were open to best behaviour bias. However, corresponding reductions in mortality outcomes suggest that changes in behaviour were real.

The factorial design introduced the possibility of interaction between the two interventions, confirmed by the analyses. The greater effect on mortality rates seen in single intervention areas than in those with both was noteworthy. One explanation might be negative synergy, where both interventions might have been saving the same lives, thus restricting the potential for combined effect. Another explanation is that combined delivery led to reduced efficiency, but this was not supported by improved coverage in areas with both interventions. Furthermore, outcomes such as EBF and skilled birth attendance were greater in areas with both interventions. For EBF, this apparent interaction existed at inception, before the womens group intervention started, suggesting that areas with both interventions differed in ways that were not compensated for by the adjusted analyses. They were either more urbanised, making interventions less easy to implement, or more remote from health facilities. They had higher IMR, NMR, and PMR at inception, but improved more than areas with no intervention during the study period (table 2).

Our results, though complicated by the factorial design and baseline imbalances after randomisation, confirm the findings from womens group trials in south Asia that reductions in mortality rates result from mobilisation of women and communities.4, 5 Of particular note is the effect on MMR, also noted in the Makwanpur trial,4 but in this case a specified primary outcome. Previous trials of breastfeeding counselling showed variable effects in sub-Saharan Africa and elsewhere.7, 10, 20 The contribution of improvements in feeding to infant survival in rural Malawi is plausible, but difficult to ascertain in this study. We did not see changes in individual home-care practices or uptake of routine primary care interventions, although 22 of 26 process variables were better in areas with volunteer peer counsellors. Infant morbidity rate from cough, fever, and diarrhoea was lower in these areas, and better recognition of illness and timely care-seeking might have contributed to a reduction in IMR.

Our study is the first trial of womens groups and volunteer peer counsellors in a rural African population and showed substantial effect on MMR, NMR, and IMR. The interventions were uncomplicated and inexpensive, and could achieve further savings at scale. Counsellors were supervised through the government public health system, and womens groups linked to government health surveillance assistants during strategy implementation, so both could be scaled up and sustained through these systems. Slow progress towards Millennium Development Goal 4 in Africa, and a lack of community trials with population mortality rates as outcomes, means that womens groups and peer counsellors deserve serious policy consideration for scale-up.

Contributors

All authors contributed to the design of the study and critically revised the report for content. CM, PK, SL, MR, and AC were responsible for the conception and overall supervision of the trial. CM and TP managed the project, data gathering and entry, and administration, with assistance from EK, HC, and AM. DO, M-LN, and AC were technical advisers for the study. JS-W supervised the cost-effectiveness analysis. GG gathered the cost and utilisation data and assisted A-MP-B in the cost-effectiveness analysis. SL, AC, CM, PK, and M-LN helped design the original trial protocol. SL designed the methods for data gathering and epidemiological surveillance system. MR and FM provided technical advice and supervised the womens group intervention. SV, EK, and HC provided technical advice and supervised the peer counselling intervention. SL did the quantitative analysis. AC, SL, CM, MR, TP, A-MP-B, HC, and EK wrote the first draft of the report and were responsible for subsequent collation of inputs and redrafting. CM and AC are guarantors for the report. GG and JS-W designed, gathered, and analysed the economic data.

Conflicts of interest

We declare that we have no conflicts of interest.

Acknowledgments

Trial funding was provided mainly by Saving Newborn Lives with later contributions from the UK Department for International Development, Wellcome Trust, Institute of Child Health, and UNICEF Malawi. We thank the Malawi Ministry of Health, Mchinji District Hospital, Mchinji district assembly and traditional leaders, MaiMwana womens group facilitators, volunteer counsellors, participating community members, and all field staff for their contributions to this study.

Supplementary appendix

PDF (1147K)

1 Rajaratnam JK, Marcus JR, Flaxman AD, et al. Neonatal, postneonatal, childhood, and under-5 mortality for 187 countries, 1970—2010: a systematic analysis of progress towards Millennium Development Goal 4. Lancet 2010; 375: 1988-2008. Summary | Full Text | PDF(7872KB) | CrossRef | PubMed

2 Black RE, Cousens S, Johnson HL, et alfor the Child Health Epidemiology Reference Group of WHO, UNICEF. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 2010; 375: 1969-1987. Summary | Full Text | PDF(1713KB) | CrossRef | PubMed

3 Malawi National Statistical Office. In: Malawi Demographic and Health Survey 2010. Zomba: Malawi National Statistical Office, 2011: 1-603.

4 Manandhar DS, Osrin D, Shrestha BP, et almembers of the MIRA Makwanpur trial team. Effect of a participatory intervention with womens groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet 2004; 364: 970-979. Summary | Full Text | PDF(465KB) | CrossRef | PubMed

5 Tripathy P, Nair N, Barnett S, et al. Effect of a participatory intervention with womens groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial. Lancet 2010; 375: 1182-1192. Summary | Full Text | PDF(914KB) | CrossRef | PubMed

6 Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev 2009; 1. CD003517

7 Taha TE, Kumwenda NI, Hoover DR, et al. The impact of breastfeeding on the health of HIV-positive mothers and their children in sub-Saharan Africa. Bull World Health Organ 2006; 84: 546-554. CrossRef | PubMed

8 Coovadia H. Current issues in prevention of mother-to-child transmission of HIV-1. Curr Opin HIV AIDS 2009; 4: 319-324. CrossRef | PubMed

9 Lewin S, Munabi-Babigumira S, Glenton C, et al. Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases. Cochrane Database Syst Rev 2010; 3. CD004015

10 Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev 2007; 1. CD001141

11 Arifeen SE, Hoque DME, Akter T, et al. Effect of the Integrated Management of Childhood Illness strategy on childhood mortality and nutrition in a rural area in Bangladesh: a cluster randomised trial. Lancet 2009; 374: 393-403. Summary | Full Text | PDF(267KB) | CrossRef | PubMed

12 Bhandari N, Bahl R, Mazumdar S, et al. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial. Lancet 2003; 361: 1418-1423. Summary | Full Text | PDF(97KB) | CrossRef | PubMed

13 Haider R, Ashworth A, Kabir I, Huttly SRA. Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial. Lancet 2000; 356: 1643-1647. Summary | Full Text | PDF(92KB) | CrossRef | PubMed

14 Aidam BA, Pérez-Escamilla R, Lartey A. Lactation counseling increases exclusive breast-feeding rates in Ghana. J Nutr 2005; 135: 1691-1695. PubMed

15 Leite Á, Puccini R, Atalah Á, Da Cunha A, Machado M. Effectiveness of home-based peer counselling to promote breastfeeding in the northeast of Brazil: a randomized clinical trial. Acta Paediatr 2005; 94: 741-746. CrossRef | PubMed

16 Jakobsen MS, Sodemann M, Biai S, Nielsen J, Aaby P. Promotion of exclusive breastfeeding is not likely to be cost effective in West Africa. A randomized intervention study from Guinea-Bissau. Acta Paediatr 2008; 97: 68-75. CrossRef | PubMed

17 Tylleskär T, Jackson D, Meda N, et alfor the PROMISE-EBF Study Group. Exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa (PROMISE-EBF): a cluster-randomised trial. Lancet 2011; 378: 420-427. Summary | Full Text | PDF(179KB) | CrossRef | PubMed

18 World Bank. World development report 2010. Development and climate change. Washington DC: World Bank, 2010.

19 Malawi National Statistical Office. In: 2008 population and housing census. Zomba: Malawi National Statistical Office, 2010: 1-23.

20 Malawi National Statistical Office, UNICEF—Malawi. Multiple indicator cluster survey 2006. Zomba: Malawi National Statistical Office, UNICEF, 2008.

21 Lewycka S, Mwansambo C, Kazembe P, et al. A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality. Trials 201010.1186/1745-6215-11-88. published online Sept 17. PubMed

22 Grabman LH, Seoane G, Davenport C. The Warmi Project: a participatory approach to improve maternal and neonatal health. An implementors manual. Westport: John Snow International, MotherCare Project, Save the Children, 2002.

23 Rosato M, Mwansambo C, Lewycka S, et al. MaiMwana womens groups: a community mobilisation intervention to improve mother and child health and reduce mortality in rural Malawi. Malawi Med J 2010; 22: 112-119. PubMed

24 Rosato M, Johnson B, Otanez MMaiMwana Project. Umodzi (together): a film about MaiMwana womens groups. Malawi. http://www.youtube.com/watch?v=vcCAwLleFx4. (accessed Jan 21, 2013).

25 Rosato M, Lewycka S, Mwansambo C, et al. Volunteer infant feeding and care counsellors: a health education intervention to improve mother and child health and reduce mortality in rural Malawi. http://www.medcol.mw/mmj/?p=1098. (accessed Jan 21, 2013.

26 Linkages. Recommended feeding and dietary practices to improve infant and maternal nutrition. http://www.linkagesproject.org/media/publications/Technical%20Reports/recfeeding.pdf. (accessed May 1, 2013).

27 WHO, UNICEF. Breastfeeding counselling: a training course. Directors guide, trainers guide, participants manual. http://www.who.int/maternal_child_adolescent/documents/who_cdr_93_3/en/. (accessed May 1, 2013).

28 Beck B, Ganges F, Goldman S, Long P. Care of the newborn: reference manual. Washington, DC: Save the Children Federation, 2004. http://fmp.ueh.edu.ht/PDF/Care_of_Newborn_SNL.pdf. (accessed May 1, 2013).

29 DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005; 365: 711-722. Summary | Full Text | PDF(457KB) | CrossRef | PubMed

30 Malawi National Statistical OfficeMacro ORC. In: Malawi demographic and health survey, 2004. Zomba: Malawi National Statistical Office, Macro ORC, 2005: 454.

31 Azad K, Barnett S, Banerjee B, et al. Effect of scaling up womens groups on birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial. Lancet 2010; 375: 1193-1202. Summary | Full Text | PDF(276KB) | CrossRef | PubMed

32 International Monetary Fund. World Economic Outlook Database. http://www.imf.org/external/pubs/ft/weo/2011/02/weodata/index.aspx. (accessed May 2, 2013).

33 Sachs J. In: Macroeconomics and health: investing in health for economic development. Report of the Commission on Macroeconomics and Health. Geneva: World Health Organization, 2001: 1-210.

34 Victora CG, Fenn B, Bryce J, Kirkwood BR. Co-coverage of preventive interventions and implications for child-survival strategies: evidence from national surveys. Lancet 2005; 366: 1460-1466. Summary | Full Text | PDF(109KB) | CrossRef | PubMed

a Institute for Global Health, University College London, London, UK

b Government of Malawi, Ministry of Health, Lilongwe, Malawi

c Baylor College of Medicine Childrens Foundation, Lilongwe, Malawi

d MaiMwana Project, Mchinji, Malawi

e Africa Centre for Health and Population Studies, University of KwaZulu-Natal, South Africa

f Health Economics and Financing Programme, London School of Hygiene and Tropical Medicine, London, UK

Correspondence to: Prof Anthony Costello, Institute for Global Health, University College London, 30 Guilford Street, London WC1N 1EH, UK