HPV Infectiona-HPVVIHNCT06507917
Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV
A study testing anal swabbing in people with HPV Infection, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
Trial summary
Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests. The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- HPV Infection
- What is being tested?
- anal swabbing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 2 sitesReunion
- Study dates
- 28 Nov 2025to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient :
- living with HIV
- aged 30 or over
- resident on Reunion island and followed at the University Hospital of Reunion Island (the only follow-up center on the island)
- Able to perform anal self-sampling
- Able to answer a questionnaire
- Affiliated with or benefiting from a social security scheme
- Have given free, informed and signed consent
Who cannot join
- People with a previous anal swab less than 7 days old
- Persons with a known current diagnosis of anal cancer
- Persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion2 sites, 2 recruiting
- Not yet recruiting
CHU de la Réunion Recherche Clinique
Saint-Denis, 97400
Kevin DIALLO, kevin.diallo@chu-reunion.fr
Kevin DIALLO
- Recruiting
CHU de la Réunion Recherche Clinique
Saint-Pierre, 97448
Kevin DIALLO, kevin.diallo@chu-reunion.fr
Kevin DIALLO
About this study
Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests.
The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population.
Read more
According to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. However, the proposal of a proctological examination in this population is not systematic.
In France, there is no HPV screening for people living with HIV, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (MSM) or for women with vaginal cervical lesions.
Several oncogenic HPV serotypes have been identified in the genesis of anal cancer. The serotype identified as the most carcinogenic is HPV-16 (89%).
This study will look at anal HPV screening in people over 30 living with HIV, thus including a population for which no screening is currently offered (heterosexual men living with HIV and women living with HIV without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.
- Conditions
- HPV Infection
- Being tested
- anal swabbing
- Keywords
- HPV, HIV, anal screening
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anal swabbingDiagnostic test
anal swabbing
| Study group | Role | What they receive |
|---|---|---|
| self-swabbing first | Experimental | Group A self-swabbing then swabbing by a healthcare professional Receives: Diagnostic Test: anal swabbing |
| swabbing by a healthcare professional first | Active comparator | swabbing by a healthcare professional and then self-swabbing Receives: Diagnostic Test: anal swabbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
HPV-16 genotype results for the sample
Measured: 7 days
Secondary outcomes (6)
Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.
HPV oncogenic genotype results for the sample
Measured: 7 days
To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.
visual scale from 0 (strongly disagree) to 10 (strongly agree)
Measured: 7 days
Compare the overall satisfaction of the 2 anal samplings.
visual scale from 0 (poor) to 10 (very good).
Measured: 7 days
Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.
discomfort, pain, bleeding, inconvenience after each swabbing
Measured: 7 days
Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional.
composite score, constructed from the satisfaction scores, from which we subtract the average of the adverse event and shame scores, asked after each swab.
Measured: 7 days
Evaluate the prevalence of anal HPV (including oncogenic HPV).
The proportion and prevalence of the various HPVs in the study population will be described.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start28 Nov 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507917
- Sponsor's protocol ID
- 2024/CHU/42
- Other IDs
- 2024-A01508-39
- Acronym
- a-HPVVIH
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2024
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV
- ClinicalTrials.gov ID
- NCT06507917
- Acronym / sponsor ID
- a-HPVVIH / 2024/CHU/42
- Conditions
- HPV Infection
- Keywords
- HPV, HIV, anal screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 18 Jul 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.
Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests.
The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population.
According to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. However, the proposal of a proctological examination in this population is not systematic.
In France, there is no HPV screening for people living with HIV, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (MSM) or for women with vaginal cervical lesions.
Several oncogenic HPV serotypes have been identified in the genesis of anal cancer. The serotype identified as the most carcinogenic is HPV-16 (89%).
This study will look at anal HPV screening in people over 30 living with HIV, thus including a population for which no screening is currently offered (heterosexual men living with HIV and women living with HIV without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-swabbing first | Experimental | Diagnostic Test: anal swabbingGroup A self-swabbing then swabbing by a healthcare professional |
| swabbing by a healthcare professional first | Active comparator | Diagnostic Test: anal swabbingswabbing by a healthcare professional and then self-swabbing |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- living with HIV
- aged 30 or over
- resident on Reunion island and followed at the University Hospital of Reunion Island (the only follow-up center on the island)
- Able to perform anal self-sampling
- Able to answer a questionnaire
Key exclusion criteria (3 listed)
- People with a previous anal swab less than 7 days old
- Persons with a known current diagnosis of anal cancer
- Persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators
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 |
|---|---|---|
| anal swabbinganal swabbing | Diagnostic test | self-swabbing first, swabbing by a healthcare professional first |
Primary outcome
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
Time frame: 7 days
HPV-16 genotype results for the sample
6 secondary outcomes
Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.
Time frame: 7 days
To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.
Time frame: 7 days
Compare the overall satisfaction of the 2 anal samplings.
Time frame: 7 days
Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.
Time frame: 7 days
Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional.
Time frame: 7 days
Evaluate the prevalence of anal HPV (including oncogenic HPV).
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anal swabbing in people with HPV Infection, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
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 8 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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 Reunion. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (0262394999 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling. (time frame: 7 days). 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 11 Dec 2025.