Strongyloides Stercoralis InfectionSCANNCT07009613
Strongyloides Stercoralis Public Health Control in Rwanda
An observational study of Strongyloides Stercoralis Infection and Strongyloides, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Rwanda.
Trial summary
The World Health Organization (WHO) recently issued guideline for the public health control of Strongyloides stercoralis in endemic areas. We aimed to evaluate the feasibility of implementing the WHO recommendations in Rwanda, specifically to intergrate the activities for the public health control of strongyloidiasis… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Strongyloides Stercoralis Infection, Strongyloides
- What is being tested?
- Parasitological tests and Questionnaire
- How many people
- 1,415 participants
- Where
- 1 siteRwanda
- Study dates
- 23 Sep 2024to 14 Oct 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People living in two districts in Rwanda
Who may be able to join
- People living in the selected districts and households
- Obtainment of written informed consent (for children's participation, consent was sought from parents/guardians).
Who cannot join
- Inability to supply an adequate stool sample
Trial locations and contacts
1 site in 1 country.
Rwanda1 site
School of Health Sciences, College of Medicine and Health Sciences, University of Rwanda
Kigali, 737
About this study
Official title: Integration of Strongyloides Stercoralis Public Health Control Into the Soil-transmitted Helminths Control Programme in Rwanda - The SCAN Study
The World Health Organization (WHO) recently issued guideline for the public health control of Strongyloides stercoralis in endemic areas. We aimed to evaluate the feasibility of implementing the WHO recommendations in Rwanda, specifically to intergrate the activities for the public health control of strongyloidiasis in the ongoing national programme for the control of the other soil-transmitted helminths and schistosomiasis, that has been in place for several years. As additional objective, we aimed to estimate the prevalence of S. stercoralis in two districts of Rwanda (Gisagara and Rubavu). To evaluate the feasibility, we asked lab technicians to evaluate challenges emerged during the implementation of the laboratory procedures with a structured questionnaire. Also, we evaluated the costs needed to perform these tests. We estimated the prevalence of S. stercoralis by calculating the number of positive cases out of all people tested. The lab technicians participated to a training session, where they were taught the S. stercoralis-specific lab techniques, and to a two-day pilot study where they could practice. The tests used were parasitological techniques (agar stool culture, (APC) and Baermann method) and an antibody rapid diagnostic test (RDT). Duration of training, with a specific focus on larvae differentiation, was identified as pivotal for a successful implementation of the parasitological techniques. The use of the RDT was instead considered easy to apply at all evaluation time points. Raw cost (i.e. not including staff salaries and transport costs) of materials and equipment was below 2 euros/test for each assay. In both districts, Strongyloides prevalence was below the threshold recommended by the WHO for the implementation of mass treatment, hence this aspect was not evaluated.
- Conditions
- Strongyloides Stercoralis Infection, Strongyloides
- Being tested
- Parasitological tests, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasitological testsDiagnostic test
The primary outcome was reported based on the technicians' answers collected with a structured questionnaire. The individuals screened underwent testing with the tests detailed above
QuestionnaireOther
The primary outcome was based on the technicians' evaluation, based on their answers collected in a questionnaire. The individuals screened were tested with assays used for the national control programmes
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the tests based on technicians' perception (through questionnaire) and costs
Technicians' previous experience with each S. stercoralis-specific assay, along with their perceptions regarding the ease of each of the procedural steps and associated safety concerns were assessed using a structured questionnaire. Each procedural step was rated as "Very easy", "Easy", "Neutral", "Difficult" and "Very difficult". For the steps marked "difficult" or "very difficult", respondents could specify the reasons for the difficulty from a predefined non-mutually-exclusive list of options. The per-test costs were calculated from the procurement records of each S. stercoralis-specific assay.
Measured: The data will be collected at baseline, during the pilot study (two - three days from baseline) and during field work (after two to three weeks from baseline)
Secondary outcomes (1)
Prevalence
Frequency of S. stercoralis cases out of the tested population
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start23 Sep 2024
- Primary completion11 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strongyloides Stercoralis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,415 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Rwanda Biomedical Centre
- Responsible party
- Principal investigator, Dora Buonfrate, IRCCS Sacro Cuore Don Calabria di Negrar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009613
- Sponsor's protocol ID
- No477/RNEC/2024
- Acronym
- SCAN
- Status last verified
- Jun 2025
- First submitted
- 17 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Strongyloides Stercoralis Public Health Control Into the Soil-transmitted Helminths Control Programme in Rwanda - The SCAN Study
- ClinicalTrials.gov ID
- NCT07009613
- Acronym / sponsor ID
- SCAN / No477/RNEC/2024
- Conditions
- Strongyloides Stercoralis Infection, Strongyloides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,415 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Collaborators
- University of Rwanda, Rwanda Biomedical Centre
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The World Health Organization (WHO) recently issued guideline for the public health control of Strongyloides stercoralis in endemic areas. We aimed to evaluate the feasibility of implementing the WHO recommendations in Rwanda, specifically to intergrate the activities for the public health control of strongyloidiasis in the ongoing national programme for the control of the other soil-transmitted helminths and schistosomiasis, that has been in place for several years. As additional objective, we aimed to estimate the prevalence of S. stercoralis in two districts of Rwanda (Gisagara and Rubavu). To evaluate the feasibility, we asked lab technicians to evaluate challenges emerged during the implementation of the laboratory procedures with a structured questionnaire. Also, we evaluated the costs needed to perform these tests. We estimated the prevalence of S. stercoralis by calculating the number of positive cases out of all people tested. The lab technicians participated to a training session, where they were taught the S. stercoralis-specific lab techniques, and to a two-day pilot study where they could practice. The tests used were parasitological techniques (agar stool culture, (APC) and Baermann method) and an antibody rapid diagnostic test (RDT). Duration of training, with a specific focus on larvae differentiation, was identified as pivotal for a successful implementation of the parasitological techniques. The use of the RDT was instead considered easy to apply at all evaluation time points. Raw cost (i.e. not including staff salaries and transport costs) of materials and equipment was below 2 euros/test for each assay. In both districts, Strongyloides prevalence was below the threshold recommended by the WHO for the implementation of mass treatment, hence this aspect was not evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People living in two districts in Rwanda
Key inclusion criteria (2 listed)
- People living in the selected districts and households
- Obtainment of written informed consent (for children's participation, consent was sought from parents/guardians).
Key exclusion criteria (1 listed)
- Inability to supply an adequate stool sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasitological testsThe primary outcome was reported based on the technicians' answers collected with a structured questionnaire. The individuals screened underwent testing with the tests detailed above | Diagnostic test | – |
| QuestionnaireThe primary outcome was based on the technicians' evaluation, based on their answers collected in a questionnaire. The individuals screened were tested with assays used for the national control programmes | Other | – |
Primary outcome
Evaluation of the tests based on technicians' perception (through questionnaire) and costs
Time frame: The data will be collected at baseline, during the pilot study (two - three days from baseline) and during field work (after two to three weeks from baseline)
Technicians' previous experience with each S. stercoralis-specific assay, along with their perceptions regarding the ease of each of the procedural steps and associated safety concerns were assessed using a structured questionnaire. Each procedural step was rated as "Very easy", "Easy", "Neutral", "Difficult" and "Very difficult". For the steps marked "difficult" or "very difficult", respondents could specify the reasons for the difficulty from a predefined non-mutually-exclusive list of options. The per-test costs were calculated from the procurement records of each S. stercoralis-specific assay.
1 secondary outcome
Prevalence
Time frame: through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strongyloides Stercoralis Infection and Strongyloides, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the tests based on technicians' perception (through questionnaire) and costs (time frame: The data will be collected at baseline, during the pilot study (two - three days from baseline) and during field work (after two to three weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.