Clinical trial NCT06213051: Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection
Official title: Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Papillomavirus Infection
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Frere Hospital, East London, South Africa
name: Bangabandhu Sheikh Mujib Medical University, Bangladesh
First posted: 2024-01-19
Enrollment: 1306
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:

* Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy)
* Able to understand scope of study
* Able to provide written informed consent
* Willing to provide all necessary samples

Exclusion Criteria:

* Vaccinated for HPV
* Pregnancy
* Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)

Primary outcomes:
measure: 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.
timeFrame: 6 Months
Secondary outcomes:
measure: 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.
timeFrame: 6 Months
measure: 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.
timeFrame: 6 Months
measure: 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.
timeFrame: 6 Months
measure: Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.
timeFrame: 6 Months
measure: 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.
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Foundation for Innovative New Diagnostics (FIND)
name: Angela Muriuki
role: STUDY_DIRECTOR
References: