Clinical trial NCT05788003: Female Genital Schistosomiasis in Tanzania
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schistosomiasis Mansoni
Keywords: Female Genital Schistosomiasis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Female Genital Schistosomiasis
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 6 months
measure: Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis
timeFrame: 6 months
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
city: Mwanza
country: Tanzania
facility: Catholic University of Health and Allied Sciences (CUHAS)
Study officials:
References: