Pandey 2007.

Methods	Study design: cluster‐randomised controlled trial Duration of study: May 2004 to May 2005 Study arms: intervention arm (public meetings) + control arm (no intervention). 21 of 70 districts were the focus of the intervention. 1 district consist of proximately 14 blocks and each block consists of 65 village clusters Methods of recruitment of participants: using a random number generator, 1 block was randomly selected within each of the 21 districts, and then 5 villages were randomly selected from each block. No blocks were adjacent to each other. The 21 districts, and the selected blocks and villages, were then randomly assigned to either intervention or control arm. 10 households were sampled in each village of which 5 were low‐caste and five were mid‐ to high‐caste. In total 548 intervention households and 497 control households were included Informed consent obtained: yes, verbal consent of individual participants was obtained Ethical approval: yes Funding: financial support from Sahbhagi Shikshan Kendra (a non‐governmental organisation based in Uttar Pradesh) and the World Bank
Participants	Setting: 21 central, central‐eastern and southern districts out of the 70 districts in Uttar Pradesh, a State in Northern India with a population of 170 million. Uttar Pradesh is ranked 23 of 32 states in India in terms of the proportion of people living below the poverty line, with one living under the poverty line. Infant mortality rate is 89 per 1000. Literacy is 56% while 46% of children are immunised. The main language spoken is Hindi Description of participants: 21 districts were randomised to receive the intervention (11 districts) or to serve as control (10 districts) 10 households per village cluster that had at least 1 child going to public primary school in the village were selected for a baseline survey (550 households in the intervention group, 500 households in the control group). Of these households, 536 (246 low‐caste, 290 mid‐ to high‐caste) participated in the final survey and are included in the postintervention analysis. Of these households, 489 (241 low‐caste, 280 mid‐ to high‐caste) participated in the final survey and were included in the postintervention analysis. A household was defined as a group of persons who commonly lived together and would take their meals from a common kitchen Parents, other family members, village leaders, children and sometimes teachers attended the meetings. Approximately 14% to 25% of residents of the villages attended the meetings (additional information obtained from the study authors) Number of participants: The number of households with infants < 1 year was as follows: Baseline assessment: intervention = 171; control = 166 Postintervention assessment: intervention = 149; control = 79
Interventions	Aim of the intervention: to support resource‐poor populations through providing information about entitled health services, educational services and governance requirements Deliverer: project research assistants. No further information provided Format or delivery mode: information campaigns were conducted in 2 rounds for each cluster, separated by 2 weeks. Each round consisted of 2 to 3 meetings and also included the distribution of leaflets and posters in the intervention villages. Residents were informed in advance about the dates and locations of meetings and separate meetings were held in low and mid‐ to high‐caste neighbourhoods. Each meeting lasted about an hour and consisted of the following: a 15‐minute audiotape presentation that was played twice; opportunities to ask questions; and distribution of leaflets. People were informed that the information was obtained from the government and distributed in the public interest by the research team and a nongovernmental organisation based in Uttar Pradesh, Sahbhagi Shikstan Kendra Content of communication: information included health services information; availability of midwives; obligations of the midwife to provide free prenatal and postnatal care including tetanus vaccines and prenatal supplements for the mother and health care and vaccines for infants; the health centres available for more specialised care; and where to complain about quality or quantity of services. Information was also included on school fees; sources and oversight of education funds; obligations of oversight committees; requirements for semi‐annual village government meetings; organisation and funding of village government and development work; rights to obtain copies of village records; and where to complain about education or village governance problems. The information in the presentation and leaflets was obtained from Uttar Pradesh health, education and village governance departments Vaccines delivered or described: infant vaccinations (not specified) and tetanus vaccination for pregnant women Direction of communication: from research assistants to community members. Community members had opportunities to ask questions Where the intervention took place: intervention communities. Separate meetings were held in low‐ and mid‐ to high‐caste areas Frequency or timing of communication: 2 rounds of 2 to 3 meetings, separated by a period of 2 weeks Training required for the intervention: not described Theoretical basis for the intervention: not described Cost of the intervention: the total cost of the intervention was USD 4000 (approximately USD 0.22 per household in a village cluster) Intervention quality: to help ensure that the intervention was delivered in a uniform way, those delivering the information read a scripted introduction and were allowed to answer questions only to which the answers were already written on the information leaflets provided Fidelity/integrity of the intervention: "According to headcounts of everyone attending our informational meetings, 14% of the residents of the entire village cluster attended in round 1 and 11% attended in round 2. If there was some overlap in attendance, we estimate that 14% to 25% of the residents of each intervention village cluster attended a presentation. We reached our target level of attendance, which was 250 people in each round (about 11% of the average village population)" (Pandey 2007 pg 1870) Details of control/usual or routine care: not described Details of co‐interventions in all groups: not described
Outcomes	Visits by nurse wife; prenatal examinations, tetanus vaccinations and prenatal supplements received by pregnant women Vaccinations received by infants Excess school fees charged Occurrence of village meetings Development work in villages Outcomes included in the review: vaccinations received by infants
Notes	The total cost of the intervention was approximately USD 4000. This included the cost of designing the intervention (for example, a professional radio journalist was hired for the audio‐recording of information played in the villages); printing materials; the tools and equipment (tape‐recorders); and the cost of hiring the research team to carry out the campaign (personal communication) Contact with the authors: we contacted the author to ask for additional information regarding: (1) The intervention. This included further details related to vaccination and in what way vaccines were a part of the intervention and more information about how communities participated in the meetings. (2) The relative risk for the vaccination outcome, adjusted for clustering and other variables. Additional information on the intervention and this outcome was received from the study authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	[All outcomes] From a comprehensive list of blocks and village clusters, they used a random number generator to randomly select 1 block within each district and then randomly select 5 village clusters within each block. They then randomly assigned districts to intervention and control arms. The method of randomisation was not described
Allocation concealment (selection bias)	Low risk	[All outcomes] The unit of allocation was by cluster and allocation was performed on all units at the start of the study
Blinding of participants and personnel (performance bias) All outcomes	Low risk	[All outcomes] 5 village clusters of about 1000 in each district were selected. The total selection of 105 village clusters was spread over the 21 districts to minimise any potential for contamination between intervention and control villages. However, participants in the intervention district would have known they were receiving intervention. The field co‐ordinator for the surveys knew which clusters received the intervention but interviewers did not. Participants in the intervention clusters would have known if they were receiving intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	[All outcomes] The follow‐up interviews were performed by a research assistant who had no knowledge of the intervention. To maintain this blinding, intervention group subjects were not asked whether they attended an informational meeting. We assessed it as unlikely that it was possible to maintain the blinding, and we are not able to find information on blinding of the people that performed the analysis
Incomplete outcome data (attrition bias) All outcomes	Low risk	[All outcomes] 12 households in the intervention group and 8 in the control group moved before the final survey
Selective reporting (reporting bias)	Unclear risk	[All outcomes] We were not able to locate a published protocol to assess if all of the outcomes listed in the original protocol were reported. Results are reported for all of the main outcomes mentioned in the trial report
Other bias	Low risk	[All outcomes] Recall bias ‐ information regarding vaccinations was obtained through interviews. We scored this as low risk of bias as it may influence both arms of the trial
Selective recruitment of participants (cluster RCTs)	Low risk	[All outcomes] The districts population were scattered (105 village clusters were spread over the 21 districts), so it is unlikely that the participants knew which villages were control or intervention clusters
Comparable baseline in intervention and control group	Low risk	[All outcomes] There was a slightly uneven distribution of low‐caste versus mid‐ to high‐caste households. Of 548 households in intervention village clusters, 252 (46%) were low‐caste. Of 497 households in control village clusters, 245 (49%) were low‐caste

DPT: diptheria, pertussis and tetanus