Human Papillomavirus InfectionHPVNCT06213051
Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection
An observational study of Human Papillomavirus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- • COPAN Self-collection FLOQSwabs® (COPAN, Italy)
- Type of treatment
- Medical device
- How many people
- 1,306 participants
- Where
- 1 siteKenya
- Study dates
- 16 May 2024to 30 Sep 2026
- Phase
- Observational
- 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Kenya Medical Research Institute (KEMRI)
Nairobi, Nairobi County, 00100
About this study
Official title: Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.
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.
Read the 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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- • COPAN Self-collection FLOQSwabs® (COPAN, Italy)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• COPAN Self-collection FLOQSwabs® (COPAN, Italy)Device
Also called COPAN Self-collection FLOQSwabs® (COPAN, Italy) with 5ml PreservCyt Solution (Hologic)
COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted19 Jan 2024
- Study start16 May 2024
- Primary completion18 Nov 2024
- Study completion30 Sep 2026 (estimated)
Why it stopped: funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Frere Hospital, East London, South Africa, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Angela Muriuki, Study director, Foundation for Innovative New Diagnostics (FIND)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213051
- Sponsor's protocol ID
- WH001
- Acronym
- HPV
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.
- ClinicalTrials.gov ID
- NCT06213051
- Acronym / sponsor ID
- HPV / WH001
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: funding issues
- Enrolment
- 1,306 participants (estimated)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Frere Hospital, East London, South Africa, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study start
- 16 May 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Jan 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of sexually active adult females with an abnormal cervical cancer screening result. | – | Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| • COPAN Self-collection FLOQSwabs® (COPAN, Italy)Also: COPAN Self-collection FLOQSwabs® (COPAN, Italy) with 5ml PreservCyt Solution (Hologic)COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs | Device | Cohort of sexually active adult females with an abnormal cervical cancer screening result. |
Primary outcome
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.
Time frame: 6 Months
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.
5 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.
Time frame: 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.
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 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Angela Muriuki study director
Foundation for Innovative New Diagnostics (FIND)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Kenya.
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 0 inclusion and 3 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: paused, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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?
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. (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 18 Sep 2026.