Condition category
Infections and Infestations
Date applied
26/04/2011
Date assigned
24/05/2011
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.psi.org/

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

Publication citations

Additional files

Editorial Notes