Evaluation of Triage Options After HPV Testing for Cervical Cancer Screening Among HIV-infected Women

NCT ID: NCT03789513

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-09-30

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 3,000 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 (CIN2+/HSIL) and to identify associated risk-factors.

Conditions

HIV Infections; HPV - Anogenital Human Papilloma Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Triage with different options

All women will have an HPV test, partial genotyping (16/18/45 versus other high-risk HPV [hr-HPV]) and VIA. The different options for triage that will be compared are:

• Participants hr-HVP+ and VIA+ participants selected for treatment;
• Participants HPV 16/18/45+ selected for treatment;
• Participant HPV 16/18/45+ and/or VIA+ selected for treatment;

Group Type: OTHER

HPV test with partial genotyping and VIA triage

Intervention Type: DIAGNOSTIC_TEST

HPV testing with the GenXpert platform VIA Biopsies of VIA+ lesions or random Treatment with thermal ablation of women with precancerous lesions

Interventions

HPV test with partial genotyping and VIA triage

HPV testing with the GenXpert platform VIA Biopsies of VIA+ lesions or random Treatment with thermal ablation of women with precancerous lesions

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women
• HIV-1 infection
• Age 30 to 49 years
• In care for HIV infection, receiving or initiating antiretroviral therapy
• Written informed consent given

Exclusion Criteria

• HIV-2 infection
• Ongoing pregnancy (evidenced by self-report or clinical examination)
• Previous total hysterectomy
• Severe concomitant disease that, according to the investigators, may contraindicate or compromise participation to the study
• History of cervical cancer screening with treatment for precancerous lesions within the last 12 months

Differed inclusion

• Ongoing heavy menstruation
• Immediate post-partum (<12 weeks post delivery)
• Sign of ongoing genital infection (e.g. mucopurulante discharge)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role: collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role: collaborator

Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University of Bordeaux

OTHER

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Debeaudrap, PhD

Role: STUDY_DIRECTOR

Ceped UMR 196

Apollinaire Debeaudrap, PhD

Role: STUDY_DIRECTOR

PACCI - Ivory Coast

Locations

HIV day care center

Bobo-Dioulasso, , Burkina Faso

Site Status: RECRUITING

Calmette Hospital

Phnom Penh, , Cambodia

Site Status: RECRUITING

CEPREF

Abidjan, , Côte d’Ivoire

Site Status: ENROLLING_BY_INVITATION

Countries

Burkina Faso; Cambodia; Côte d’Ivoire

Central Contacts

Pierre Debeaudrap, PhD

Role: CONTACT

pierre.debeaudrap@ird.fr

(0) 1 76 53 34 53 ext. +33

Apollinaire Horo, PhD

Role: CONTACT

horoapollinaire@gmail.com

Facility Contacts

Armel Poda

Role: primary

Kim Sothea

Role: primary

Other Identifiers

ANRS12375 AIMA-CC

Identifier Type: -

Identifier Source: org_study_id