Female Genital Schistosomiasis in Tanzania

Schistosomiasis Mansoni Clinical Trial

— ShWAB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05788003
• Other study ID #: 2022-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: March 2023
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schistosomiasis
• Schistosomiasis mansoni

Intervention

Diagnostic Test:
• self-collected and operator-collected swab followed by molecular analysis
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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona
Tanzania	Catholic University of Health and Allied Sciences (CUHAS)	Mwanza

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Countries where clinical trial is conducted

Italy,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Female Genital Schistosomiasis	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	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)	The participant will be asked some questions about her clinical history and about her experience with self-sampling.	6 months
Secondary	Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis	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