Condition category
Infections and Infestations
Date applied
21/10/2014
Date assigned
13/01/2015
Last edited
09/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Safe management and reuse of wastewater and faecal sludge for irrigating crops and as a fertilizer is of growing importance for people living in urban areas in Africa and Asia. In this study we focus on wastewater management and reuse schemes in Kampala, Uganda, and Hanoi, Vietnam. Kampala city, the capital city of Uganda, treats wastewater and faecal sludge for reuse around the Bugolobi Sewerage Treatment and Disposal Works. Hence, wastewater is reused for irrigation downstream of the plant within the Nakivubo swamp, where farmers grow crops. Hanoi, the capital city of Vietnam, is one of these Asian cities where large open storm water and drainage channels convey the wastewater out of the city. In the Than Tri district, a peri-urban area of Hanoi, wastewater is reused in agriculture and aquaculture, which creates important livelihood opportunities and is a valuable source of fresh vegetables and fish for the city. Although these recovered products are beneficial for agriculture, such practices might pose risks for both human and animal health. We want to obtain and compare the relevant health risks between selected people who are exposed to wastewater and/or faecal sludge (farmers reusing wastewater, communities living close to the wastewater channels and workers who operate wastewater facilities and collect faecal sludge) with people who are not exposed to wastewater and/or faecal sludge. The results will help the people living and working along wastewater systems to safely manage and reuse water and nutrients in the future.

Who can participate?
Adults that are wastewater treatment plant workers, faecal sludge collectors, urban farmers, people living close to wastewater channels, and people that do not come in contact with wastewater channels.

What does the study involve?
Participants are interviewed for about 30 minutes to obtain data on demographics, occupation, socio-economic status, levels of hygiene, their consumption of water and food, any symptoms of disease, their perception of risk from wastewater and faecal sludge and personal protective equipment. After the interview we ask participants to provide a stool sample the next morning to check for parasitic infection. The results are announced as they become available and remain confidential. Participants that are infected with parasites are treated for free.

What are the benefits and risks of the study
The main benefit to participating in this study include free professional treatment for parasitic infection. Participants are also likely to support the sanitation planning of Kampala and Hanoi city, respectively, and help to protect people who are living and working along wastewater channels. To prevent any risk participants are told in detail about the study processes at each step.

Where is the study run from?
Nakivubo area of Kampala city (Uganda)
Than Tri district, Hanoi (Vietnam)

When is the study starting and how long is it expected to run for?
October 2013 to October 2015

Who is funding the study?
Swiss Agency for Development and Cooperation (SDC).

Who is the main contact?
Prof. Dr Guéladio Cissé
guealdio.cisse@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guealdio Cisse

ORCID ID

Contact details

Swiss Tropical and Public Health Institute
University of Basel
Department of Epidemiology and Public Health (EPH)
Socinstr. 57
Basel
4002
Switzerland
+41 (0)61 284 83 04
gueladio.cisse@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Health risk assessment along the wastewater and faecal sludge chains: case study in Kampala and Hanoi

Acronym

N/A

Study hypothesis

The difference in odds ratio is 2.5 or higher between highly exposed groups (people working along the wastewater and faecal sludge chain) and the people without an exposure to the two waste chains (control groups).

On 09/07/2015 the trial record was updated to add Hanoi (Vietnam) as a study site.

Ethics approval

1. Ethics committee of Basel (Ethikkommission beider Basel); 07/08/2013; ref: 137/13
2. Makerere University School of Public Health: Higher Degrees Research and Ethics Committee; 10/07/2014; ref: IRBOOO1l353
3. Uganda National Council of Science and Technology (UNCST) in Kampala, Uganda and office of the president of the republic of Uganda; approved study period: 08/10/2013-08/10/2015; ref: HS1487
4. Hanoi School of Public Health (HSPH), 26/02/2014, ref : 010/2014/YTCC-HD3

Study design

Cross-sectional survey, epidemiological survey, environmental sampling, quantiative microbial risk assessment

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Communicable diseases (soil-transmitted helminth, Schistosoma mansoni and intestinal protozoa infection )

Intervention

Administer a questionnaire interview for about 30 minutes to obtain data on demographics, occupation, socio-economic status, hygienic behavior, consumption of water and food, disease symptoms, health seeking, risk perception and personal protective equipment. The data is entered directly into a data entry mask of a tablet computer during the interview and will be synchronized with a secure server from Swiss Tropical and Public Health Institute in Switzerland every evening. The access to the database is restricted to the main investigators of the study. After the analysis we will make the results anonymous and share them with the stakeholders and participants.

After the interview we will invite participants to provide a stool sample the next morning for the detection of parasitic infection. Stool samples will be analysed by a laboratory technician the Ministry of Public Health. The results will be announced as they become available and will remain confidential. In case we detect any parasitic infection we will come back to the participant and provide treatment for free. All participants tested positive for soil-transmitted helminth or Schistosoma mansoni will be treated with a single dose of albendazole (400 mg) and praziquantel (40 mg/kg), respectively.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Differences in parasitic infection between exposure groups (worker, farmer, community members)

Secondary outcome measures

Prevalence of communicable diseases and related risk factor in an urban East-African and Southeast Asian setting

Overall trial start date

08/10/2013

Overall trial end date

08/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants were enrolled in case they belong to following exposure groups: Wastewater treatment plant workers, faecal sludge workers, farmers and community members.
2. Willing to sign a written consent from, submit a stool sample and conduct a questionnaire interview

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

1000 participants to assess the existing exposure risks due to wastewater and faecal sludge in directly exposed groups

Participant exclusion criteria

1. Too sick to attend school or participate in the study (e.g. severe diarrhoea, severe anaemia, high fever, etc.)
2. Absence of written informed consent
3. Person is younger than 18 years of age

Recruitment start date

08/10/2013

Recruitment end date

08/10/2015

Locations

Countries of recruitment

Uganda, Viet Nam

Trial participating centre

Swiss Tropical and Public Health Institute
Basel
4002
Switzerland

Sponsor information

Organisation

Swiss Tropical and Public Health Institute

Sponsor details

c/o Guealdio Cisse
Department of Epidemiology and Public Health (EPH)
Socinstr. 57
Basel
4002
Switzerland
+41 (0)61 284 83 04
gueladio.cisse@unibas.ch

Sponsor type

University/education

Website

http://www.swisstph.ch/

Organisation

World Health Organization (WHO)

Sponsor details

-
-
-
Switzerland

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

Swiss Agency for Development and Cooperation (SDC)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25545942
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26122126

Publication citations

Additional files

Editorial Notes