ClinicalTrials.gg
CompletedNCT07009613SCANUpdated Jun 6, 2025

Strongyloides Stercoralis Public Health Control in Rwanda

An observational study in Strongyloides Stercoralis Infection and Strongyloides, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Completed at 1 site in Rwanda. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,415
Ages
5 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Strongyloides Stercoralis Infection
  • Strongyloides
03

In context

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

People living in two districts in Rwanda

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People living in the selected districts and households
  • Obtainment of written (for children's participation, consent was sought from parents/guardians).

Exclusion criteria

Exclusion Criteria:

  • Inability to supply an adequate stool sample
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,415 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testParasitological tests

    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

  • OtherQuestionnaire

    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

06

What researchers measure

Primary outcomes

  1. 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.

    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)

Secondary outcomes

  1. Prevalence

    Frequency of S. stercoralis cases out of the tested population

    Time frame: through study completion

07

Study locations

1 site
  • School of Health Sciences, College of Medicine and Health Sciences, University of Rwanda
    Kigali, 737, Rwanda
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2024 to primary completion in Oct 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2025
First posted
Jun 6, 2025
StartActual
Sep 23, 2024
Primary completionActual
Oct 11, 2024
CompletionActual
Oct 14, 2024
Last update
Jun 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07009613
Lead sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Collaborators
University of Rwanda, Rwanda Biomedical Centre
Responsible party
Dora Buonfrate (Head of infectious disease Clinical Research Unit, IRCCS Sacro Cuore Don Calabria di Negrar) — Principal investigator
First posted
Jun 6, 2025
Start date
Sep 23, 2024
Primary completion
Oct 11, 2024
Completion
Oct 14, 2024
Last update
Jun 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion