Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men (NCT02287961) | Clinical Trial Compass
CompletedNot Applicable
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
France516 participantsStarted 2014-12-02
Plain-language summary
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution.
Estimated enrolment: 500
Principal Outcomes
* Detection of high-grade cytological and histological anal lesions by high resolution anoscopy
* Spontaneous regression of high-grade anal lesions
* Detection of anal HPV infection
Intervention (procedure):
* Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):
\- anal biopsy(ies) during HRA
Only if high-grade lesion:
\- HRA biannually
Who can participate
Age range
35 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men who have sex with men
* At least 35 years old
* HIV-positive (documented search of HIV infection, with HIV status determined according to HAS algorithm)
* Signed informed consent
* Affiliated to or beneficiary of French social security
* All severity criteria and evolution of HIV disease are accepted (including AIDS stage and co-infections)
Exclusion Criteria:
* Contraindication to biopsy
* History of anal cancer or pelvic radiotherapy
* AIN2/3 treated during previous year
* Current anticancer chemotherapy or within 24 months before inclusion
* Difficulty in evaluation (anus reshaped and/or scarred)
* Individual placed under judicial protection
* Foreseen absence which may hamper participation; insufficient motivation; associated pathology with priority for care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of high-grade anal lesions by high resolution anoscopy
Timeframe: Initial inclusion visit
2
Evaluation of anal HPV infection by DNA, RNA and protein detection
Timeframe: Initial inclusion visit
3
Quantification of spontaneous regression of high-grade anal lesions