Deworming and Health Education: A project to address intestinal worms in rural Guizhou province
| ISRCTN | ISRCTN97311712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97311712 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/04/2013
- Registration date
- 30/04/2013
- Last edited
- 30/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Our team's 2010 survey of poor, rural areas of Guizhou Province found rates of infection with soil transmitted helminths (STHs) to be around 40%. But Chinese government officials are not convinced that STH infection poses any real problem to Chinese schoolchildren. The goal of this study is to see whether an intensive campaign to reduce STH infection has any impact on child health or cognitive performance.
Who can participate?
Our sample will include both school-aged (9-11 years) and preschool-aged (3-5 years) children in the sample villages.
What does the study involve?
The study will have one intervention group and one control group with no intervention. The intervention involves administration of two rounds of albendazole treatment for all village children over age 3 years, health education training for both children and their parents, and an invitation to a health training session led by a local Centers for Disease Control and Prevention (CDC) official.
What are the possible benefits and risks of participating?
All children participating in the study will be dewormed (children in the control group will be dewormed at the conclusion of the endline survey), and families in the intervention group will also have the opportunity to learn about the dangers of STH infection and ways to prevent it. The risks of participating in the study are minimal - albendazole is safe with minimal side effects, mainly limited to mild stomach cramps as the STHs die and are expelled from the host body.
Where is the study run from?
110 villages in poor parts of rural Guizhou Province.
When is the study starting and how long is it expected to run for?
The study will begin in May, 2013, and will continue for 12 months until May, 2014.
Who is funding the study?
The study is funded by grants from the International Initiative for Impact Evaluation (3ie), the UBS Optimus Foundation, and Stanford University.
Who is the main contact?
Alexis Medina
amedina5@stanford.edu
Contact information
Scientific
616 Serra Street
Encina Hall E407
Stanford
94305
United States of America
Study information
| Study design | Interventional cluster-randomised single-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Deworming and Health Education: A cluster-randomized single-blind controlled trial to address soil-transmitted helminths in rural Guizhou province |
| Study objectives | The goal of this study is to see whether an intensive campaign to reduce STH infection has any impact on child health or cognitive performance. This project involves treatment of children with soil-transmitted helminth infection (Ascaris, hookworm, Trichuris). Depending on the number of worms harbored, infection with parasitic intestinal worms can cause a range of symptoms, including diarrhea, general sickness and weakness, impaired cognitive development, stunted growth, and chronic intestinal blood loss. |
| Ethics approval(s) | Ethical approval was provided by the Stanford University Human Subjects Research Institutional Review Board on the 15th September 2012 (ref: 25027) |
| Health condition(s) or problem(s) studied | Soil-transmitted helminth infection |
| Intervention | Villagers in the intervention group will participate in the following activities: 1. All village children over age 3 years will be administered two 400 mg tablets of albendazole: one tablet at the start of the project, and another one after 6 months. The local CDC (with help of the village doctor) will be responsible for medication distribution and administration. 2. All parents of sampled children will receive one-on-one health education training from a trained project team member. 3. All school-aged children in our sample will receive health education training from a trained project team member 4. All parents of children in the village will be invited to a health training session led by a local CDC official with the help of the village doctor. Villagers in the control group will not participate in any study interventions (no treatment). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Albendazole |
| Primary outcome measure | 1. Soil-transmitted helminths (STH) infection rate, measured by a Kato-Katz smear test 2. Child height and weight 3. Student academic performance, measured by performance on a standardized Trends in International Mathematics and Science Study (TIMSS) test 4. Educational readiness for preschool-aged children, measured by performance on a standardized test of educational readiness 5. Cognitive processing, as measured by performance on a test of executive function Measured at baseline and at end line (12 months after baseline). |
| Secondary outcome measures | 1. Hemoglobin levels, measured by HemoCue 201+ technology 2. Worm burden [eggs per gram (epg)] Measured at baseline and at endline (12 months after baseline). |
| Overall study start date | 21/04/2013 |
| Completion date | 21/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | 3300 children |
| Key inclusion criteria | All school-aged (9-11 years) and preschool-aged (3-5 years) children living in our sample villages in poor parts of rural Guizhou Province will be included in the study. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 21/04/2013 |
| Date of final enrolment | 21/04/2014 |
Locations
Countries of recruitment
- China
- United States of America
Study participating centre
94305
United States of America
Sponsor information
University/education
616 Serra Street
Encina Hall East, 5th floor
Stanford
94305
United States of America
| Website | http://www.stanford.edu/ |
|---|---|
"ROR" |
https://ror.org/00f54p054 |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
