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

Natural History of Anal Human Papillomavirus Infection and Associated Disease in HIV-infected Men Who Have Sex With Men: Towards an Evidence Base for the Prevention of Anal Cancer.

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

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