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 |
| Protocol serial number | 10-02140 |
| Sponsor | Population Services International (USA) |
| Funder | Population Services International (USA) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 objectives | 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(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) studied | 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 |
| Primary outcome measure(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 |
| Key secondary outcome measure(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. |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10714 |
| Key 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 |
| Key exclusion criteria | Absent on two attempts to contact. In this case, the next nearest eligible household is substituted. |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Myanmar
- United States of America
Study participating centre
94105
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
