Pre-Exposure ProphylaxisANAPreP'HPVNCT06296602
Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)
A study testing A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. in people with Pre-Exposure Prophylaxis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pre-Exposure Prophylaxis
- What is being tested?
- A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2024to 4 Nov 2024
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.
Who cannot join
- Women
- No MSM
- Under 18
- History of HPV related cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Cédric LEBRETON, Dr
About this study
Official title: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV
This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.
Read the detailed description
The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.
This will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
A questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.
- Conditions
- Pre-Exposure Prophylaxis
- Being tested
- A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
- Keywords
- PreP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.Other
Also called A questionnaire will be completed by the doctor to record the data of interest
A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest.
| Study group | Role | What they receive |
|---|---|---|
| ANAPreP-HPV | Experimental | A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
A questionnaire will be completed by the doctor to record the data of interest. Receives: Other: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence HPV
prevalence HPV
Measured: day 1
typing HPV
typing HPV
Measured: day 1
Secondary outcomes (2)
High risk HPV risk factors
High risk HPV risk factors
Measured: day 1
Cytologist abnormalies
Cytologist abnormalies
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Mar 2024
- Primary completion4 Nov 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296602
- Sponsor's protocol ID
- 2023/777
- Acronym
- ANAPreP'HPV
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV
- ClinicalTrials.gov ID
- NCT06296602
- Acronym / sponsor ID
- ANAPreP'HPV / 2023/777
- Conditions
- Pre-Exposure Prophylaxis
- Keywords
- PreP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 6 Mar 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 is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.
Detailed description
The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.
This will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.
A questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest.
| Arm | Type | Receives |
|---|---|---|
| ANAPreP-HPV | Experimental | Other: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.
Key exclusion criteria (4 listed)
- Women
- No MSM
- Under 18
- History of HPV related cancer
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 |
|---|---|---|
| A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.Also: A questionnaire will be completed by the doctor to record the data of interestA prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. A questionnaire will be completed by the doctor to record the data of interest. | Other | ANAPreP-HPV |
Primary outcome
prevalence HPV
Time frame: day 1
prevalence HPV
typing HPV
Time frame: day 1
typing HPV
2 secondary outcomes
High risk HPV risk factors
Time frame: day 1
Cytologist abnormalies
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Pre-Exposure Prophylaxis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
HIV Prevention, HIV Pre-exposure Prophylaxis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections. in people with Pre-Exposure Prophylaxis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 1 inclusion and 4 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 8 Mar 2024. 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 France. 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?
Contact Cedric LEBRETON, Dr (03 81 21 88 98 ext. +33, c1lebreton@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence HPV (time frame: day 1). The study lists 2 primary outcomes in all. 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 8 Mar 2024; AzTrials last refreshed its copy on 4 Nov 2026.