Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01792973
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2013-02-11
Brief Title:
HPV Infection and Cervical Lesions in HIV Infected Women in Thailand A Prospective Study
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
HPV Infection and Cervical Lesions in HIV Infected Women in Thailand
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PapilloV
Brief Summary:
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
Detailed Description:
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 CIN2 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
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 CIN2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None