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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Frere Hospital, East London, South Africa | UNKNOWN |
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | OTHER |
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This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.
Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.
This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of sexually active adult females with an abnormal cervical cancer screening result. | Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA. Interventions: COPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • COPAN Self-collection FLOQSwabs® (COPAN, Italy) | Device | COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard. | Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the performance of self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard. | Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. |
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Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:
Exclusion Criteria:
Adult Females only
Participants are eligible to be included in the study only if all of the inclusion criteria and none of the exclusion criteria indicated below apply.
Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rita Szekely | Contact | +41 22 749 29 32 | rita.szekely@finddx.org | |
| Debashish Das | Contact | +447708561187 | debashish.das@finddx.org |
| Name | Affiliation | Role |
|---|---|---|
| Angela Muriuki | Foundation for Innovative New Diagnostics (FIND) | Study Director |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 6 Months |
| Compare the performance of self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard. | Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. | 6 Months |
| Compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard. | Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected dry swabs to self-collected wet swabs for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard. | 6 Months |
| Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers. | Assessment of survey responses using descriptive statistics. | 6 Months |
| Assess the usability of self-collection amongst women and to assess the usability of self-collection using vaginal dry swabs compared to self-collection using vaginal wet swabs and provider collection methods for HPV testing amongst health care workers. | Assessment of survey responses using descriptive statistics. | 6 Months |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |