Contact information
Type
Scientific
Primary contact
Dr Dominic Montagu
ORCID ID
Contact details
UCSF Global Health Sciences
Global Health Group
50 Beale Street
Suite 1200
San Francisco
94105
United States of America
-
montagud@globalhealth.ucsf.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10-02140
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pediatric diarrhea and pneumonia
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
01/09/2010
Overall trial end date
31/05/2012
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/09/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Myanmar
Trial participating centre
UCSF Global Health Sciences, Global Health Group
San Francisco
94105
United States of America
Sponsor information
Organisation
Population Services International (USA)
Sponsor details
1120 19th Street
NW
Suite 600
Washington
20036
United States of America
-
klongfield@psi.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Population Services International (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401752