HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study (PapilloV)
HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical lesion. The study will also provide the distribution of the HPV genotypes involved as well as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is provided according to the National Guidelines.
|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|