ShWAB: Female Genital Schistosomiasis in Tanzania

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05788003

Collaborator

(none)

206

Enrollment

Locations

8.4

Anticipated Duration (Months)

103

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Schistosomiasis Mansoni	Diagnostic Test: self-collected and operator-collected swab followed by molecular analysis	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 4, 2022

Anticipated Primary Completion Date :

Mar 17, 2023

Anticipated Study Completion Date :

Mar 17, 2023

Outcome Measures

Primary Outcome Measures

Prevalence of Female Genital Schistosomiasis [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

Secondary Outcome Measures

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) [6 months]
The participant will be asked some questions about her clinical history and about her experience with self-sampling.
Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona	Italy	37024
2	Catholic University of Health and Allied Sciences (CUHAS)	Mwanza		Tanzania

Sponsors and Collaborators

IRCCS Sacro Cuore Don Calabria di Negrar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Sacro Cuore Don Calabria di Negrar

ClinicalTrials.gov Identifier:

NCT05788003

Other Study ID Numbers:

2022-07

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRCCS Sacro Cuore Don Calabria di Negrar

Female Genital Schistosomiasis

Additional relevant MeSH terms:

Schistosomiasis

Schistosomiasis mansoni

Study Results

No Results Posted as of Mar 28, 2023