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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN73606238
Date of registration: 24/05/2011
Prospective Registration: No
Primary sponsor: Population Services International (USA)
Public title: Evaluating the impact of a training and social franchising program in addressing the prevention and treatment of diarrhea and pneumonia in Children Under 5 (CU5) among the poor in rural areas of Myanmar
Scientific title: A randomized controlled trial evaluating the impact of a training and social franchising program in addressing the prevention and treatment of diarrhea and pneumonia in Children Under 5 (CU5) among the poor in rural areas of Myanmar
Date of first enrolment: 01/09/2010
Target sample size: 10714
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN73606238
Study type:  Interventional
Study design:  Randomized controlled trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Myanmar
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Dominic    Montagu
Address:  UCSF Global Health Sciences, Global Health Group 50 Beale Street Suite 1200 94105 San Francisco United States of America
Telephone: -
Email: montagud@globalhealth.ucsf.edu
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. The mother (first choice) and/or other primary caregiver (if mother not available or able to participate) of at least one CU5
2. Resident of the sampled household, defined as sleeping in the house the previous night and having no other usual residence
3. Age 18 years or older. Of note, PSI Myanmar ethical review recommends not including minors in research. In typical surveys of mothers of CU5, another caregiving adult (e.g., grandmother, father, aunt) can provide the relevant information for the children of mothers under the age of 18 years. Moreover, someone other than the mother is interviewed in < 5% of such surveys
4. Able to speak and provide informed consent in the majority language of Myanmar (Burmese). Of note, the our townships constituting the target area are located within the majority Burmese ethnic area

Exclusion criteria: Absent on two attempts to contact. In this case, the next nearest eligible household is substituted.

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Pediatric diarrhea and pneumonia
Infections and Infestations
Diarrhoea and gastroenteritis of presumed infectious origin
Intervention(s)
The scale up of a social franchising program seeking to improve health in rural Myanmar through training and supplying of partners known as 'Sun Primary Health' (SPH) providers (e.g., rural health educators, midwives, pharmacists, traditional healers, educators, and others).

It is the introduction of a trained provider who is part of the franchise into the community. SPH providers are trained and supported to provide health communications, services, and commodities related to RH, diarrheal diseases, pneumonia, and malaria, and provide referrals for TB and other acute illnesses to SQH clinics. SPH members are not salaried, but receive financial incentives from PSI/M based on performance. It is a two-three day training course.

The SPH providers will impart the knowledge by delivering healthcare as needed. There will not be specific sessions dedicated to educating the community but the information will flow to community members via interactions with the SPH when they deliver health services.
Primary Outcome(s)
1. The difference in use of appropriate treatment for diarrhea within the last two weeks by mothers/primary care givers for CU5 in intervention versus control village tracts
2. The difference in recognition of danger signs of pneumonia among mothers/primary care givers of CU5 in intervention versus control village tracts
3. The differences in socio-economic status (SES) of households of users of appropriate treatment for diarrhea in CU5 versus non-users in intervention village tracts
4. The differences in SES of households aware versus unaware of the danger signs of pneumonia in CU5 in intervention village tracts

The survey to measure outcomes will be drawn at baseline (pre-SPH program), 12 months, and 24 months for repeated representative surveys
Secondary Outcome(s)
The study will also address secondary aims related to a behavior change model encompassing opportunity, ability, and motivation (OAM model) to improve health status.

Additional data collection will include exposures to the social franchising products and providers, perceived quality of care and services at the social franchising outlets, additional history of child health outcomes and treatments sought and used, and additional demographic information. The population-basis of the surveys allows for extrapolation of findings over similar areas of rural Myanmar that are poised to implement the Sun Primary Health (SPH) program.
Secondary ID(s)
10-02140
Source(s) of Monetary Support
Population Services International (USA)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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