CTRI Number	CTRI/2017/02/007792 [Registered on: 07/02/2017] Trial Registered Prospectively
Last Modified On:	06/02/2017
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Behavioral Other (Specify) [Community engagement]
Study Design	Cluster Randomized Trial
Public Title of Study Modification(s)	Evaluation of a Community Engagement Approach in Improving Immunization Coverage
Scientific Title of Study	Impact Assessment of the SALT (Stimulate, Appreciate, Learn, and Transfer) Approach of Community Engagement to Increase Immunisation Coverage through Ownership – a Mixed Methods Study in Assam
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Sandra Albert  Address  Indian Institute of Public Health - Shillong Lawmali, Pasteur Hill, Shillong East Khasi Hills MEGHALAYA 793001 India  Phone  03642592014   Fax     Email  sandra.albert@phfi.org
Details Contact Person Scientific Query Modification(s)	Name  Arpita Ghosh  Address  Public Health Foundation of India Plot No. 47, Sector 44, Institutional Area, Gurgaon Gurgaon HARYANA 122002 India  Phone  01244781400   Fax     Email  arpita.ghosh@phfi.org
Details Contact Person Public Query	Name  Santanu Pramanik  Address  Public Health Foundation of India Plot No. 47, Sector 44, Institutional Area, Gurgaon Gurgaon HARYANA 122002 India  Phone  8826487408   Fax     Email  santanu.pramanik@phfi.org
Source of Monetary or Material Support Modification(s)	International Initiative for Impact Evaluation (3ie) 202-203, 2nd Floor, Rectangle One, D-4, Saket District Centre, New Delhi, Delhi 110017
Primary Sponsor	Name  Public Health Foundation of India  Address  Plot No. 47, Sector 44, Institutional Area, Gurgaon – 122002  Type of Sponsor  Research institution
Details of Secondary Sponsor	Name  Address  The Constellation a non governmental organization  Sentier des 5 Bonniers, 25 1390 Grez-Doiceau, Belgium
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Samina Parveen  Bongaigaon  Bongaigaon Bongaigaon   7308530137 samina.parveen@phfi.org
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Immunization coverage of children aged 6-23 months old
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Control group  Control villages continue to receive routine immunization services. No additional intervention is provided.  Intervention  Ownership through community engagement  The community engagement approach is formally known as SALT. The acronym SALT stands for Stimulate, Appreciate, Learn, and Transfer. The intervention starts with visits by local trained facilitators to communities that are randomly assigned to receive the SALT intervention. The goal of the facilitators is to bring the community together to discuss the common values they share. The facilitators then stimulate the discussion with the objective of building a common dream around the community. In our context, this would be the dream of healthy children in the community and immunization as a component can contribute to healthy children. Once the community embraces the dream, a self-assessment exercise starts, under the guidance of the facilitator, in order to understand where the community stands today with respect to its dream. Then discussion will evolve around what actions need to be taken in order to fulfil the dream. The community itself comes up with the action plan, based on its strengths and resources. This is followed by the action phase and the review process. Facilitators then bring communities together to share with and learn from each other. This process is formally known as the ‘learning festival’. Then the community revisits the dream, review of self-assessment happens, community revises the action plan, followed by the action phase, sharing and learning from each other, and so the cycle continues.
Inclusion Criteria	Age From  1.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  The entire village which has been randomly assigned to receive the intervention is eligible for this community engagement approach. However, data will be collected from households (HHs) having children in the age group of 6-23 months.
ExclusionCriteria	Details  Villages having less than 50 HHs (getting enough number of eligible households–having children in the age group 6 to 23 months- would be a challenge). Villages having more than 500 HHs (might be difficult to get the community together and hence implementation could be a challenge). Villages which were not accessible at baseline due to security concerns or flood situation.
Method of Generating Random Sequence	Adaptive randomization, such as minimization
Method of Concealment	Centralized
Blinding/Masking	Investigator Blinded
Primary Outcome	Outcome  TimePoints  Full immunization coverage in children 12-23 months old Coverage of three doses of OPV and DPT/Pentavalent vaccine in 6-23 month old children Dropout rates between different doses of OPV and Pentavalent/DPT  2 years
Secondary Outcome	Outcome  TimePoints  Awareness of immunization service provision in mothers Knowledge of the benefits of immunization Health service utilization of mothers Belief that community ownership and action is required to improve health of children Belief that the community can mobilize to take action to prevent their children from getting sick Engaging in community action to identify solutions to improve immunization Sharing knowledge of health promotion practices with others  2 years
Target Sample Size	Total Sample Size="2700" Sample Size from India="2700"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	20/02/2017
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	None yet.
Brief Summary	We adopt a cluster randomized trial to evaluate the impact of a community engagement approach on vaccination coverage-related indicators. Cluster randomized design is appropriate here as opposed to individual or household level randomization as the intervention is intended for implementation at the village level. The study site is Assam, a north-eastern state of India. We selected 3 districts from Assam- Kamrup rural, Bongaigaon, and Udalguri. We will assess the intervention’s impact on primary outcomes full immunization coverage in children 12-23 months old, coverage of three doses of DPT/Pentavalent vaccine in 6-23 month old children, dropout rates between different doses of pentavalent/DPT and OPV. The study involves 90 villages per group, intervention and control, leading to a total of 180 villages in Assam across 3 districts. Outcome assessments will be based on 15 eligible households (having children in the age group of 6-23 months) from each village resulting in a total sample size of 2700 households.