The shows the trial profile; 48 clusters were randomly assigned equally to interventions—women’s group plus volunteer peer counselling, women’s 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 women’s group intervention on May 1, 2005. We took the 6 months’ inception, Jan 1, to June 30, 2005, as a baseline for the women’s group intervention, and an establishment period for the volunteer peer counselling intervention. 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 women’s 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 (). The opposite was true for areas with the women’s group intervention—lower delivery and postnatal care, and highest perceived maternal problems than in control areas—though early wrapping and breastfeeding were better (). Clusters with only the women’s group intervention had the lowest uptake of antenatal and postnatal care and HIV testing, and higher perceived maternal problems (). Exclusive breastfeeding was highest in areas with both interventions, suggesting early effects of volunteer peer counselling (and not an interaction because the women’s group intervention had not begun; ).
Characteristics of identified pregnancies in intervention groups during the inception period
Four women’s 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 women’s 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 women’s 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.
summarises the numbers of births and deaths in each group. Mortality rates were higher in the women’s group (with or without volunteer peer counselling) than in the non-women’s group (volunteer peer counselling only or no intervention) clusters at inception, and highest in clusters given both interventions (women’s group plus volunteer peer counselling). PMR, NMR, and IMR fell consistently over 3 years in areas given the women’s group intervention with or without volunteer peer counselling; MMR also fell, with the largest reductions in years 2 and 3 (). Non-women’s group clusters did not show a similar pattern (). Generally, IMR was lower in clusters assigned to volunteer peer counselling (alone or with women’s groups) than in those assigned to non-volunteer peer counselling (women’s groups or no intervention) and was lowest in volunteer peer counselling only clusters throughout the study.
Births, deaths, and mortality rates in intervention groups during 2005–09
summarises the analyses of the primary outcomes for the women’s group intervention. There was no difference between women’s group and no women’s 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; ). 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 (). 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.
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 (). Exclusive breastfeeding showed an increase of 74% and complete immunisation at 6 months showed a greater than 2·5 times increase ().
Secondary outcomes in intervention and control clusters for the two interventions (women’s 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 (). 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 (). Stratified analysis showed large effects on IMR in areas without women’s groups (adjusted OR 0·64, 0·48–0·85), but no effect in areas with women’s 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 ( and ); however, stratified analysis showed that these effects were not significant in areas without women’s 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; ). 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 (), 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 ().
No differences were noted in use of family planning, or other antenatal, delivery, and postnatal care-seeking (). 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 ().
The presence of both interventions in a cluster improved coverage, with 2192 (57%) of 3874 women with available attendance data having ever attended a women’s group by 1 month post partum, compared with 1975 (50%) of 3941 in clusters with women’s 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 (). Striking effects were noted on MMR with women’s groups only, and on IMR with volunteer peer counselling only in years 1–3. 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 women’s group intervention only (). With the exception of MMR, adjusted ORs in areas with both interventions were near to 1·00 (). 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 (). 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 (). This pattern was the same as at inception, before the women’s groups had started, and could not have been due to interaction ().
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 women’s group only, and 1·10 (0·72–1·67) for volunteer peer counselling only.
The total economic cost of the women’s 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 women’s group intervention. In years 1–3, 258·5 infant deaths were averted by the volunteer peer counselling intervention. The cost of the women’s 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 (women’s group), $6·3 per infant (volunteer peer counselling), and $5·6 per woman of childbearing age (women’s 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 women’s group and $205 446 (78%) of the cost of the volunteer peer counselling group were for implementation.