HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study (PapilloV)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||HPV Infection and Cervical Lesions in HIV Infected Women in Thailand|
- 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 ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
- To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
- To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
- To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone
- To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
- 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
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.
Descriptive statistics, univariate and multivariate analyses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792973
|Bhumibol Adulyadej Hospital|
|Saimai, Bangkok, Thailand|
|Prapokklao, Muang, Chantaburi, Thailand, 22000|
|Mae Rim, Chiang Mai, Thailand, 50180|
|Muang, Chiang Mai, Thailand, 51000|
|Sanpatong, Chiang Mai, Thailand, 20120|
|Mae Chan Hospital|
|Mae Chan, Chiang Rai, Thailand|
|Mae Sai Hospital|
|Mae Sai, Chiang Rai, Thailand, 57130|
|Phan, Chiang Rai, Thailand, 57120|
|Chiangrai Prachanukroh Hospital|
|Muang, Chiangrai, Thailand|
|Muang, Chonburi, Thailand, 20000|
|Muang, Lampang, Thailand, 52000|
|Muang, Mahasarakam, Thailand, 44000|
|Muang, Nakhonpathom, Thailand, 73000|
|Nong Khai Hospital|
|Muang, Nong Khai, Thailand|
|Chiang Kham Hospital|
|Chiang Kham, Phayao, Thailand, 56110|
|Muang, Pitsanulok, Thailand|
|Muang, Ratchaburi, Thailand|
|Muang, Rayong, Thailand, 21000|
|Pak Nam, Samutprakarn, Thailand|
|Muang, Samutsakorn, Thailand|
|Hat Yai Hospital|
|Hat Yai, Songkla, Thailand, 90110|
|Maharat Nakhon Ratchasima Hospital|
|Phayao, Thailand, 56000|
|Principal Investigator:||Sophie Le Coeur, MD, PhD||Institut National d'Etudes Démographiques|
|Principal Investigator:||Gonzague Jourdain, MD, PhD||Institut de Recherche pour le Developpement|
|Principal Investigator:||Nicole Ngo-Giang- Huong, PharmaD, PhD||Institut de Recherche pour le Developpement|
|Principal Investigator:||Isabelle Heard, MD, PhD||Centre national de réference des papillomavirus humains, Institut Pasteur|
|Principal Investigator:||Aram Limtrakul, MD||Nakornping Hospital, Minsitry of Public Health|
|Principal Investigator:||Nantasak Chotivanich, MD||Chonburi Hospital, Minsitry of Public Health|
|Principal Investigator:||Chaiwat Putiyanun, MD||Chiang Kham Hospital, Ministry of Public Health|
|Principal Investigator:||Samreung Rangdaeng, Associate professor||Department of Pathology Faculty of Medicine, Chiang Mai University|