HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study (PapilloV)

• High risk HPV infection [ Time Frame: January 2015 ] [ Designated as safety issue: No ]
  
• Cervical lesions: cytological abnormalities of squamous cells: ASC-US, ASC-H, LSIL, HSIL or SCC (ASCUS +) or glandular cells (AGC, AGC favor neoplasia or adenocarcinoma) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  

Title of the study: HPV Infection and Cervical Lesions in HIV infected Thai Women - A Prospective Study Country: Thailand Study period: 3 years Planned enrollment duration: 6 months

Primary objectives:

1. To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
2. To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
3. To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone

Secondary objectives:

1. To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
2. To evaluate cyto-histology performances at different hospital levels Methods: A multicenter prospective cohort study nested in the PHPT cohort.

Inclusion criteria: HIV infected women, older than18 years of age, followed in the PHPT cohort or in the same hospitals.

Exclusion criteria: Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial Planned number of patients to be enrolled: 884

Follow-up procedures:

Annual gynecological examination with a Pap-smear and a sampling for HPV testing is planned.

Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection will be referred to a colposcopist.

In case of abnormalities at the colposcopy, a biopsy will be performed.

• If the biopsy is normal or shows a CIN1, the women will be referred for a new colposcopic examination 6 months later.
• If the biopsy shows CIN2 or more, treatment will be provided -LEEP or conisation, or hysterectomy, and the women will be referred for a new colposcopic examination 6 months later.

Biological and pathological procedures:

• Pap-smears will be read by local pathologists in participating hospital.
• Biopsies will be read by local pathologists in participating hospital.
• HPV tests will all be performed in the PHPT virological laboratory in Chiang Mai.

Statistical methodology:

Descriptive statistics, univariate and multivariate analyses.