Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03789513
Status:
UNKNOWN
Last Update Posted:
2022-02-16
First Post:
2018-09-03
Brief Title:
Evaluation of Triage Options After HPV Testing for Cervical Cancer Screening Among HIV-infected Women
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Evaluation of Screening Algorithms Based on Self-collection and HPV Testing With Partial Genotyping for the Prevention of Cervical Cancer Among HIV-infected Women in Low-income Countries
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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:
AIMA-CC
Brief Summary:
Cervical cancer is the most common cause of cancer and a leading cause of death among HIV-infected women living in resource-limited settings Although screening for premalignant lesions is an effective way of reducing cervical cancer incidence its uptake in low-resource settings to date is low The use of HPV testing for primary screening is currently recommended by many guidelines - including the WHO guidelines for cervical cancer screening in resource-limited settings - because of its greater sensitivity and ease of use compared to other options However these WHO guidelines have both highlighted the need to conduct more research on appropriate HPV-based algorithms among HIV-infected women as immunodeficiency may affect the screening performance Indeed HPV infections in HIV-infected women are very common so there is a need for additional triage to identify women most at risk and there remains considerable uncertainty on the optimal option for such triage Most of the evidence available comes from HIV-negative populations living in high-resource settings and is not necessarily relevant for low-resource contexts where the epidemiological background is different women access late to screening and may not have follow up visits where financial constraints are important and health service resources limited
Hence the proposed project aims to provide evidence on the effectiveness and feasibility of HPV-based screening algorithms among HIV-infected women in low-resource settings
This multicenter cross-sectional study will include 3000 HIV-infected women 30-49 years old receiving HAART and followed in Abidjan Ivory Coast Bobo-Dioulasso Burkina Faso and Phnom Penh Cambodia
After self-collection of cervico-vaginal samples each participant will have an HPV test with partial genotyping primary using the Xpert HPV assay a real-time PCR assay that provides the possibility of identifying 14 HR-HPV types within one hour The Xpert HPV test has been chosen because of the wide availability of the Genexpert platform in HIV care centers from resource-limited settings Furthermore it can specifically detect HPV-16 18 and 45 the most carcinogenic HPV types in both HIV-negative and HIV-positive women separately from other high-risk HPV types VIA will be another triage option either alone or combined to HPV DNA genotyping
In addition participants treated for cervical lesion will be followed over 12 months to assess the risk of post-treatment lesions CIN2HSIL and to identify associated risk-factors
Hence the proposed project aims to provide evidence on the effectiveness and feasibility of HPV-based screening algorithms among HIV-infected women in low-resource settings
This multicenter cross-sectional study will include 3000 HIV-infected women 30-49 years old receiving HAART and followed in Abidjan Ivory Coast Bobo-Dioulasso Burkina Faso and Phnom Penh Cambodia
After self-collection of cervico-vaginal samples each participant will have an HPV test with partial genotyping primary using the Xpert HPV assay a real-time PCR assay that provides the possibility of identifying 14 HR-HPV types within one hour The Xpert HPV test has been chosen because of the wide availability of the Genexpert platform in HIV care centers from resource-limited settings Furthermore it can specifically detect HPV-16 18 and 45 the most carcinogenic HPV types in both HIV-negative and HIV-positive women separately from other high-risk HPV types VIA will be another triage option either alone or combined to HPV DNA genotyping
In addition participants treated for cervical lesion will be followed over 12 months to assess the risk of post-treatment lesions CIN2HSIL and to identify associated risk-factors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None