Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men

ANRS, Emerging Infectious Diseases516 enrolled

Overview

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

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 (Atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (ASC-H), High grade Superficial Intra-epithelial Lesion (HSIL) or AIN2/3): \- HRA biannually

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

Interventions

Standard proctologic examinationPROCEDURE

(with digital rectal examination and 2 anal swabs) at initial inclusion visit, M12 and M24 follow-up visits and if applicable M6 and M18 control visits

High resolution anoscopyPROCEDURE

at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits

Biopsy(ies) during High Resolution AnoscopyPROCEDURE

only if lesion suggestive of AIN detected during High Resolution Anoscopy

High Resolution Anoscopy biannuallyPROCEDURE

Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

Eligibility

Sex: MALEMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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