NCT07009613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

18 days

First QC Date

May 17, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

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.

    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

    through study completion

Interventions

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

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

Eligibility Criteria

Age5 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People living in two districts in Rwanda

You may qualify if:

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

You may not qualify if:

  • Inability to supply an adequate stool sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Sciences, College of Medicine and Health Sciences, University of Rwanda

Kigali, 737, Rwanda

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of infectious disease Clinical Research Unit

Study Record Dates

First Submitted

May 17, 2025

First Posted

June 6, 2025

Study Start

September 23, 2024

Primary Completion

October 11, 2024

Study Completion

October 14, 2024

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations