Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000012370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/10/2025
Date registered
Help: Date registered
6/01/2026
Date last updated
Help: Date last updated
2/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a multi-component drug and school and community based health and sanitation interventions for elimination of Schistosoma mekongi in endemic communities in Cambodia and Lao PDR
Scientific title
Effectiveness of a multi-component drug, water, sanitation and hygiene (WASH), and health intervention in reducing Schistosoma mekongi infection and transmission in humans and animals among endemic communities in Cambodia and Lao PDR
Additional trial identifiers [1] 315726 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Schistosomiasis 339443 0
Condition category
Condition code
Infection 335697 335697 0 0
Other infectious diseases
Public Health 335698 335698 0 0
Health promotion/education
Public Health 335699 335699 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Baseline pre intervention followed by a 12 month follow-up to assess impact of the intervention.

Mass drug administration (MDA)
All consented individuals will be treated with a single dose of praziquantel (PZQ) (40 mg/kg) orally via tablet. Tablets will be administered individually by local health staff. Staff will observe participants taking the drug. This treatment is in line with the national control programs of both Cambodia and Lao PDR.

School based health education
A health education package 'The Magic Glasses' is being developed for schistosomiasis mekongi, based on previous iterations developed for soil-transmitted helminths. The Magic Glasses education intervention will be performed in schools linked to study villages. This will be delivered in two phases: initially after the baseline survey and subsequently 6-8 weeks following the initial delivery. At both phases the same health education package will be delivered. 'The Magic Glasses' consists of a short cartoon (10 to 12 minutes in duration) which educates about Schistosoma mekongi, its health impacts, ways to prevent infection/re-infection, and importance of treatment. There will also be drawing and essay competitions which will be given in a form of school assignments after the video showing as reinforcement activity to further enforce messaging, and pamphlets, developed at the same time as the Magic Glasses by the infectious diseases and public health teams from Australia, Lao PDR, Cambodia and Japan, with key messages will be distributed following the initial video showing.

'The Magic Glasses' video and pamphlets are being developed specially for this project but will be made freely available post study.

Community health education
Community wide information, education and communication (IEC) materials will be developed and used across all participating communities. These materials will include information billboards (featuring key messages on S. mekongi prevention) in each village and educational brochures distributed during the community lectures. All the IEC materials will be initially developed in English and subsequently translated to the local language of each country to be distributed by local health care workers. IEC materials will be provided and available at the village health centers for the duration of the entire study in intervention villages and at the end of the study in control villages. Resources will be made freely available at conclusion to the study.

Latrine coverage (Cambodia)
We aim to increase latrine coverage in all villages to above 90%. Households in all study villages (control and intervention) will be revisited by local health officers, Rural development department and CNM staff, to confirm latrine status and encourage having a latrine. Households lacking a latrine who want to build a latrine will be provided with the building materials and relevant guidance on how to build the latrine. Three 1 hour community lectures will be conducted in the first month of the trial to promote S. mekongi awareness and improve practices. Each session will cover key topics including S. mekongi (its transmission, signs and symptoms and preventive measures), as well the importance of latrine, how to build latrine and its maintenance. To reinforce the information shared during the lecture, brochures on S. mekongi and latrine construction and maintenance will be developed and distributed for participants to take home. Those who attend the latrine information sessions and wish to build one will be given a ticket for materials. Those who take a ticket will be followed up later to check if construction occurred.

Study duration
The study will take place over an estimated 15 months which will include recruitment and implementation of interventions as well as the 12 month period to follow up. Actual study time may vary depending on external factors such as weather.
Intervention code [1] 332349 0
Prevention
Intervention code [2] 332350 0
Treatment: Other
Description of the comparator or control
Control villages will receive only a single dose of praziquantel (PZQ) (40 mg/kg) orally via tablet, in line with the national control programs of both Cambodia and Lao PDR. Tablets will be administered individually by local health staff. Staff will observe participants taking the drug.

The full intervention will be delivered to control villages after follow-up.
Control group
Active

Outcomes
Primary outcome [1] 343242 0
The primary outcome of the study will be the cumulative incidence S. mekongi infections in humans
Timepoint [1] 343242 0
Baseline and 12 month follow-up
Secondary outcome [1] 453766 0
Secondary outcomes will be change in knowledge and behaviours
Timepoint [1] 453766 0
Baseline and 12-month follow-up
Secondary outcome [2] 453767 0
Cumulative incidence of S. mekongi infection in animals
Timepoint [2] 453767 0
Baseline and 12-month follow-up

Eligibility
Key inclusion criteria

For baseline and 12 month follow-up, the following are the inclusion and exclusion criteria:

a) resident of the village selected for the study,
b) resident of the village for >12 months,
c) 5-75 years of age,
d) will not be migrating in the next year,
e) will continuously reside in the study area over the study period,
f) the resident has given informed consent, resident minors have the informed consent of their parent/guardian, and assent from minors aged 12 - 17 years
Minimum age
5 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis will include the following study cohorts: 1) those with stool samples at baseline 2) those with a KAP questionnaire at baseline. Two multi-level models will be developed to evaluate the impact of the intervention on primary and secondary outcomes: one combining data across both countries, and another stratified by country.
Generalized estimating equation (GEE) models will be employed accounting for household level clustering and repeated measurements on the same individuals nested within households and villages. These models will calculate the relative risk (RR) and this estimate will be used to assess the effectiveness of the intervention for the primary outcomes. Multivariate regression models (covariates will include baseline infection status and other relevant covariates identified from preliminary analyses) will be used for formal analyses of incidence (log-binomial model) and intensity of infection (log-negative binomial model). Sub-group analysis maybe undertaken to evaluate the intervention effect by baseline prevalence and infection intensity levels.
Scores for the knowledge and behaviour (secondary outcomes) will be calculated as percentages. Differences between groups will be expressed in percentages points and will be analyzed using linear regression. GEE model will also use to take account of clustering within villages/households and repeated measurements on the same individuals overtime.
Animal host (e.g., domestic dogs and bovines) data will be summarized descriptively in terms of prevalence and infection density. eDNA data will be also summarized at each survey time point.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/03/2026
Actual
12/03/2026
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
4000
Accrual to date
1580
Final
Recruitment outside Australia
Country [1] 27512 0
Cambodia
State/province [1] 27512 0
Kratie
Country [2] 27513 0
Lao People's Democratic Republic
State/province [2] 27513 0
Champasak

Funding & Sponsors
Funding source category [1] 320332 0
Government body
Name [1] 320332 0
The National Health and Medical Research Council (NHMRC)
Country [1] 320332 0
Australia
Primary sponsor type
Government body
Name
National Centre for Parasitology, Entomology and Malaria Control
Address
Country
Cambodia
Secondary sponsor category [1] 322914 0
Government body
Name [1] 322914 0
Lao Tropical and Public Health Institute
Address [1] 322914 0
Country [1] 322914 0
Lao People's Democratic Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318879 0
Queensland Institute of Medical Research Berghofer Human Research Ethics Committee
Ethics committee address [1] 318879 0
Ethics committee country [1] 318879 0
Australia
Date submitted for ethics approval [1] 318879 0
31/03/2026
Approval date [1] 318879 0
10/04/2026
Ethics approval number [1] 318879 0
P4056
Ethics committee name [2] 319227 0
National Ethics Committee for Health Research
Ethics committee address [2] 319227 0
Ethics committee country [2] 319227 0
Cambodia
Date submitted for ethics approval [2] 319227 0
23/10/2025
Approval date [2] 319227 0
25/12/2025
Ethics approval number [2] 319227 0
Ethics committee name [3] 319228 0
National Ethics Committee for Health Research in Lao PDR
Ethics committee address [3] 319228 0
Ethics committee country [3] 319228 0
Lao People's Democratic Republic
Date submitted for ethics approval [3] 319228 0
23/10/2025
Approval date [3] 319228 0
11/03/2026
Ethics approval number [3] 319228 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145538 0
Dr Catherine Gordon
Address 145538 0
QIMR Berghofer, 300 Herston Rd, Herston QLD 4006
Country 145538 0
Australia
Phone 145538 0
+61 07 38453069
Fax 145538 0
Email 145538 0
[email protected]
Contact person for public queries
Name 145539 0
Catherine Gordon
Address 145539 0
QIMR Berghofer, 300 Herston Rd, Herston QLD 4006
Country 145539 0
Australia
Phone 145539 0
+61 07 38453069
Fax 145539 0
Email 145539 0
[email protected]
Contact person for scientific queries
Name 145540 0
Catherine Gordon
Address 145540 0
QIMR Berghofer, 300 Herston Rd, Herston QLD 4006
Country 145540 0
Australia
Phone 145540 0
+61 07 38453069
Fax 145540 0
Email 145540 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• Ministry's of Health of Laos and Cambodia

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.