Female Genital Schistosomiasis in Tanzania

NCT05788003 | Unknown

• 1 other identifier: 2022-07
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 2

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.

Conditions

Schistosomiasis Mansoni

Keywords

Female Genital Schistosomiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  6 months

• Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis

  6 months

Interventions

self-collected and operator-collected swab followed by molecular analysis DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (2)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

Location

Catholic University of Health and Allied Sciences (CUHAS)

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Schistosomiasis mansoni

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 28, 2023
• Study Start: July 4, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

TA (1); IT (1)