HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study (PapilloV)
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|ClinicalTrials.gov Identifier: NCT01792973|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : October 22, 2021
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||829 participants|
|Official Title:||HPV Infection and Cervical Lesions in HIV Infected Women in Thailand|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- High risk HPV infection [ Time Frame: January 2015 ]HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68
- High grade cervical lesions [ Time Frame: Up to 3 years ]Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792973
|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|