Schistosomiasis MansoniShWABNCT05788003
Female Genital Schistosomiasis in Tanzania
A study testing self-collected and operator-collected swab followed by molecular analysis in people with Schistosomiasis Mansoni, run by IRCCS Sacro Cuore Don Calabria di Negrar at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis Mansoni
- What is being tested?
- self-collected and operator-collected swab followed by molecular analysis
- How many people
- 206 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jul 2022to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Tanzania1 site
Catholic University of Health and Allied Sciences (CUHAS)
Mwanza
About this study
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
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.
Read the 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
- Being tested
- self-collected and operator-collected swab followed by molecular analysis
- Keywords
- Female Genital Schistosomiasis
- Medical subject headings
- Schistosomiasis mansoni
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-collected and operator-collected swab followed by molecular analysisDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
The participant will be asked some questions about her clinical history and about her experience with self-sampling.
Measured: 6 months
Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis
Sensitivity of the two genital sampling methods will be calculated using the composite reference constituted by positivity in at least one genital swab, and the performance of the two methods.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start4 Jul 2022
- Primary completion17 Mar 2023 (estimated)
- Study completion17 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosomiasis MansoniStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788003
- Sponsor's protocol ID
- 2022-07
- Acronym
- ShWAB
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be shared together with the paper describing the study results.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788003
- Acronym / sponsor ID
- ShWAB / 2022-07
- Conditions
- Schistosomiasis Mansoni
- Keywords
- Female Genital Schistosomiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (actual)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 17 Mar 2023 (estimated)
- Study completion
- 17 Mar 2023 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-collected and operator-collected swab followed by molecular analysisA 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. | Diagnostic test | – |
Primary outcome
Prevalence of Female Genital Schistosomiasis
Time frame: 6 months
Prevalence of Female Genital Schistosomiasis among women aged 18-45 years living in selected villages of Itilima and Maswa districts, North-western Tanzania
2 secondary outcomes
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)
Time frame: 6 months
Sensitivity and specificity of self-collected versus healthcare operator speculum-aided collected cervico-vaginal samples for diagnosis of Female Genital Schistosomiasis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Yes. Study data will be shared together with the paper describing the study results.
Related trials for Schistosomiasis Mansoni
Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
Schistosomiasis, Schistosoma Mansoni
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-collected and operator-collected swab followed by molecular analysis in people with Schistosomiasis Mansoni, run by IRCCS Sacro Cuore Don Calabria di Negrar at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Female Genital Schistosomiasis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.