Female Genital Schistosomiasis in Tanzania

NCT ID: NCT05788003

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2023-03-17

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.

Conditions

Schistosomiasis Mansoni

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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,

Exclusion Criteria

• willing to participate to the study as documented by signing the informed consent form.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy

Catholic University of Health and Allied Sciences (CUHAS)

Mwanza, , Tanzania

Countries

Italy; Tanzania

Other Identifiers

2022-07

Identifier Type: -

Identifier Source: org_study_id