Condition category
Not Applicable
Date applied
15/05/2010
Date assigned
20/05/2010
Last edited
20/05/2010
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 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 measures

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

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

http://www.riotintosimandou.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes