Female Genital Schistosomiasis in Tanzania (ShWAB)

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Active, not recruiting

Conditions: Schistosomiasis Mansoni

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05788003

2022-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)