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

ISRCTN ISRCTN73606238
DOI https://doi.org/10.1186/ISRCTN73606238
Secondary identifying numbers 10-02140
Submission date
26/04/2011
Registration date
24/05/2011
Last edited
27/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dominic Montagu
Scientific

UCSF Global Health Sciences, Global Health Group
50 Beale Street
Suite 1200
San Francisco
94105
United States of America

montagud@globalhealth.ucsf.edu

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesThe primary hypothesis (and basis of the sample size) is that households in village tracts receiving the intervention will have a different level of appropriate treatment of diarrhea in children under 5 (CU5) compared to those in control village tracts. Other hypotheses to be tested include differences in intervention versus control villages in terms of knowledge of diarrhea and pneumonia danger signs, awareness of treatment in the area, and access to treatment. The study will also test the hypothesis that the intervention serves the poorer part of society through comparing household socio-economic status (SES) among users and non-users of appropriate treatment.
Ethics approval(s)University of California, San Francisco, Human Research Protection Program, The Committee on Human Research, 08/06/2010, Reference: 003942, IRB: 10-02140
Health condition(s) or problem(s) studiedPediatric diarrhea and pneumonia
InterventionThe 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.
Intervention typeOther
Primary outcome measure1. 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 measuresThe 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.
Overall study start date01/09/2010
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants10,714, assuming a 70% participation rate of eligible households
Key inclusion criteria1. 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
Key exclusion criteriaAbsent on two attempts to contact. In this case, the next nearest eligible household is substituted.
Date of first enrolment01/09/2010
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Myanmar
  • United States of America

Study participating centre

UCSF Global Health Sciences, Global Health Group
San Francisco
94105
United States of America

Sponsor information

Funders

Funder type

Research organisation

Population Services International (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2014 Yes No
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