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

NCT03789513 | Unknown

• 1 other identifier: ANRS12375 AIMA-CC
• Study Type: interventional
• Target: 3,000
• Locations: 3 countries
• Sites: 3

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

Keywords

HIV infection, HPV infection, cervical cancer, screening algorithms; recurrence

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the triage options

  Sensitivity of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard

  Day 0

• Specificity of the triage options

  Specificity of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard

  Day 0

Secondary Outcomes (11)

• Positive and negative predictive value (PPV and NPV) of the triage options

  Day 0

• Positive and negative diagnostic likelihood ratio (DLR) of the triage options

  Day 0

• Acceptability and feasibility

  Day 0 and Week 1

• Prevalence of CIN2+ lesions

  Day 0

• Prevalence of CIN3+ lesions

  Day 0

Study Arms (1)

Triage with different options

OTHER

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;

Diagnostic Test: HPV test with partial genotyping and VIA triage

Interventions

HPV test with partial genotyping and VIA triage DIAGNOSTIC_TEST

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

Triage with different options

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut de Recherche pour le Developpement: collaborator
• International Agency for Research on Cancer: collaborator
• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire: collaborator
• University Hospital, Geneva: collaborator
• University of Bordeaux: collaborator

Study Sites (3)

HIV day care center

Bobo-Dioulasso, Burkina Faso

RECRUITING

Calmette Hospital

Phnom Penh, Cambodia

RECRUITING

CEPREF

Abidjan, Côte d’Ivoire

ENROLLING BY INVITATION

MeSH Terms

Conditions

HIV Infections; Papillomavirus Infections; Uterine Cervical Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Pierre Debeaudrap, PhD

  Ceped UMR 196

  STUDY DIRECTOR

• Apollinaire Debeaudrap, PhD

  PACCI - Ivory Coast

  STUDY DIRECTOR

Central Study Contacts

Pierre Debeaudrap, PhD

CONTACT

(0) 1 76 53 34 53; pierre.debeaudrap@ird.fr

Apollinaire Horo, PhD

CONTACT

horoapollinaire@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: December 28, 2018
• Study Start: March 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); BU (1); CÔ (1)