Contact information
Type
Scientific
Primary contact
Dr Mark Divall
ORCID ID
Contact details
NewFields LLC
Health Impact Assessment Unit
Chatham Road 29
Irene
Pretoria
South Africa
+27 (0)12 667-6965
mdivall@newfields.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Baseline health survey of the communities around the concession area of the proposed Simandou project in Guinea: A cross-sectional household-based and school-based epidemiological survey
Acronym
BHS Simandou Guinea
Study hypothesis
A baseline health survey will provide quality data for profiling the health status of communities potentially affected by a large-scale iron ore project in a remote area of Guinea. Such data will become the benchmark to monitor future project-related health impacts.
Ethics approval
Approved by the National Ethics Committee for Health Research (Comite National d'Ethique pour la Recherche en Sante [CNERS]) (ref. 04/CNERS/10)
Study design
Cross-sectional household-based and school-based epidemiological survey in 14 sentinel sites
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Other
Trial type
Quality of life
Patient information sheet
1. Community sensitization documents (in poster format at central locations in sentinel sites (e.g. health post)
2. Written informed consent sheet
Condition
Baseline health survey (malaria, intestinal parasites, anaemia, malnutrition, hypertension)
Intervention
1. Antimalarial treatment (artesunate-amodiaquine)
2. Anthelminthic treatment (albendazole plus praziquantel)
3. Iron and vitamin supplement
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Anaemia prevalence (according to standard WHO criteria)
2. Malaria prevalence (according to rapid diagnostic tests)
3. Prevalence of stunting and wasting
4. Prevalence of hypertension
5. Prevalence and intensity of intestinal parasites (helminths)
Secondary outcome measures
Health-related knowledge, attitudes and practices in adult population
Overall trial start date
19/05/2010
Overall trial end date
03/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Written informed consent by head of household
2. Written informed consent by parents and/or legal guardians for children aged <15 years
3. The following inclusion criteria will be applied according to specific surveys:
3.1. Questionnaire survey: adult population (aged >15 years)
3.2. Anaemia survey: children aged < 5 years and women in reproductive age (15-49 years)
3.3. Malaria prevalence survey: children aged < 5 years
3.4. Anthropometric survey: children aged < 5 years
3.5. Blood pressure survey: adult population (aged >15 years)
3.6. Parasite prevalence survey: school-aged children (aged 6-15 years)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Approximately 2,240 individuals (i.e., 280-420 households (median: 35); estimated mean household size: 5 individuals (n=1,750); plus 14 schools with 35 children per school (n=490)
Participant exclusion criteria
No written informed consent
Recruitment start date
19/05/2010
Recruitment end date
03/06/2010
Locations
Countries of recruitment
Guinea
Trial participating centre
NewFields LLC
Irene
Pretoria
South Africa
Sponsor information
Organisation
Rio Tinto SIMFER SA (Guinea)
Sponsor details
Immeuble Kankan - Cité chemin de fer
Conakry
BP 848
Guinea
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Rio Tinto, Simandou Iron Ore Project (Guinea)
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
Basic results (scientific)
Publication list