Female Genital Schistosomiasis in Tanzania (ShWAB)

March 15, 2023 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

Female Genital Schistosomiasis in Tanzania: Evaluation of Prevalence and Performance of Schistosoma Haematobium-specific Polymerase Chain Reaction (PCR) on Operator-based and Self-collected Cervical-vaginal Samples Among Women Living in Endemic Areas, North-western Tanzania

A cross-sectional survey will be conducted among 200 volunteering women aged 18- 45 years and having had prior sexual activity living in the target villages of Itilima and Maswa districts, North-western Tanzania. A single midday urine sample and two cervical-vaginal swabs (both self-collected and speculum-aided collected by a female healthcare worker) will be obtained from participating women and processed using urine filtration and polymerase chain reaction (PCR) for cervico-vaginal samples. A pre-tested structure questionnaire will be used to collect sociodemographic, clinical, and sampling acceptability information from participants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A cross-sectional survey will be conducted among 200 volunteering women aged 18-45 years and having had prior sexual activity living in the target villages of Itilima and Maswa districts, North-western Tanzania. A single midday urine sample and two cervical-vaginal swabs (both self-collected and speculum-aided collected by a female healthcare worker) will be obtained from participating women and processed using urine filtration and polymerase chain reaction (PCR) for cervico-vaginal samples. A pre-tested structure questionnaire will be used to collect sociodemographic, clinical, and sampling acceptability information from participants. Prevalence of Female Genital Schistosomiasis (FGS) will be estimated based on positivity of at least one genital specimen. Quantitative data will be described using means/medians and standard deviation/interquartile range, as appropriate. Qualitative data will be described as numbers and percentages, and compared using Chi-squared or Fisher Exact test, as appropriate. Sensitivity of the two genital sampling methods will be compared using the composite reference constituted by positivity in at least one genital swab, and the performance of the two methods compared using Cohen's Kappa statistics, Fisher's Exact test and parametric/nonparametric test for comparison of PCR Ct values, as appropriate.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Sacro Cuore Don Calabria hospital
  • Tanzania
      • Mwanza, Tanzania
        • Catholic University of Health and Allied Sciences (CUHAS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-45 years,
  • having had prior sexual activity (to allow speculum-aided gynaecological visit and genital sampling),
  • resident in any of the selected village of Itilima and Maswa districts,
  • irrespective of complaining of urogenital symptoms,
  • not reporting any exclusion criteria,
  • willing to participate to the study as documented by signing the informed consent form.

Exclusion Criteria:

  • Menstruation at the time of visit (since this limits visualization of the cervix and correct sampling);
  • no prior sexual activity (since this does not allow the use of a speculum in the visit);
  • known pregnancy;
  • documented treatment for schistosomiasis in the past 6 months;
  • age <18 or >45 years;
  • unwilling to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Female Genital Schistosomiasis
Time Frame: 6 months
Prevalence of Female Genital Schistosomiasis among women aged 18-45 years living in selected villages of Itilima and Maswa districts, North-western Tanzania
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of different sample collection and diagnostic approaches (genital self-sampling, speculum-aided collected genital sampling conducted by female or hypothetically by male healthcare workers)
Time Frame: 6 months
The participant will be asked some questions about her clinical history and about her experience with self-sampling.
6 months
Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis
Time Frame: 6 months
Sensitivity of the two genital sampling methods will be calculated using the composite reference constituted by positivity in at least one genital swab, and the performance of the two methods.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Anticipated)

March 17, 2023

Study Completion (Anticipated)

March 17, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be shared together with the paper describing the study results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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