NCT05788003

Female Genital Schistosomiasis in Tanzania

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-04
• Primary completion: 2023-03-17
• Completion: 2023-03-17
• First posted: 2023-03-28
• Last updated: 2023-03-28

Locations

2 sites across 2 countries: Italy, Tanzania