Baseline health survey of the communities around the concession area of the proposed Simandou project in Guinea

ISRCTN	ISRCTN88762301
DOI	https://doi.org/10.1186/ISRCTN88762301
Secondary identifying numbers	N/A

Submission date: 15/05/2010
Registration date: 20/05/2010
Last edited: 20/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Divall
Scientific

NewFields LLC
Health Impact Assessment Unit
Chatham Road 29
Irene
Pretoria
South Africa

Phone	+27 (0)12 667-6965
Email	mdivall@newfields.com

Study information

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
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	1. Community sensitization documents (in poster format at central locations in sentinel sites (e.g. health post) 2. Written informed consent sheet
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
Study acronym	BHS Simandou Guinea
Study objectives	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(s)	Approved by the National Ethics Committee for Health Research (Comite National d'Ethique pour la Recherche en Sante [CNERS]) (ref. 04/CNERS/10)
Health condition(s) or problem(s) studied	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
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 study start date	19/05/2010
Completion date	03/06/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	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)
Key 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)
Key exclusion criteria	No written informed consent
Date of first enrolment	19/05/2010
Date of final enrolment	03/06/2010

Locations

Countries of recruitment

Guinea
South Africa

Study participating centre

NewFields LLC

Irene
Pretoria
South Africa

Sponsor information

Rio Tinto SIMFER SA (Guinea)
Industry

Immeuble Kankan - Cité chemin de fer
Conakry
BP 848
Guinea

Website	http://www.riotintosimandou.com/
"ROR"	https://ror.org/05m7zw681

Funders

Funder type

Industry

Rio Tinto, Simandou Iron Ore Project (Guinea)

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