Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Dominic Montagu


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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


Study hypothesis

The 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

University of California, San Francisco, Human Research Protection Program, The Committee on Human Research, 08/06/2010, Reference: 003942, IRB: 10-02140

Study design

Randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Pediatric diarrhea and pneumonia


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.

Intervention type



Not Applicable

Drug names

Primary outcome measure

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

10,714, assuming a 70% participation rate of eligible households

Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

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

Sponsor information


Population Services International (USA)

Sponsor details

1120 19th Street
Suite 600
United States of America

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Population Services International (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2014 results in:

Publication citations

Additional files

Editorial Notes