Clinical Trials

MainTitle

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 (AIMA-CC)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified December 2018 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborator
Institut de Recherche pour le Developpement
International Agency for Research on Cancer
PACCI, Abidjan, Côte d'Ivoire
University Hospital, Geneva
University of Bordeaux

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT03789513

First received: September 3, 2018
Last updated: December 27, 2018
Last Verified: December 2018
History of Changes
Purpose

Purpose

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 (30-59 years old) receiving HAART and followed in Mfou (Cameroun), 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.

Condition Intervention
HIV Infections
HPV - Anogenital Human Papilloma Virus Infection

Diagnostic Test : HPV test with partial genotyping and VIA triage

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • Sensitivity of the triage options [ Time Frame: Day 0 ]
    Sensitivity of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard
  • Specificity of the triage options [ Time Frame: Day 0 ]
    Specificity of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard
Secondary Outcome Measures:
  • Positive and negative predictive value (PPV and NPV) of the triage options [ Time Frame: Day 0 ]
    PPV and NPV of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard
  • Positive and negative diagnostic likelihood ratio (DLR) of the triage options [ Time Frame: Day 0 ]
    Positive and negative DLR of the triage options to detect CIN2+ and CIN3+ lesions with histology as the reference standard
  • Acceptability and feasibility [ Time Frame: Day 0 and Week 1 ]
    Acceptability and feasibility of the self-sampling, of the different triage options and of the treatment cervical lesions
  • Prevalence of CIN2+ lesions [ Time Frame: Day 0 ]
    Prevalence of CIN2 lesions, overall and by sub-groups defined by age categories, current CD4-cell count, nadir CD4-cell count and treatment history
  • Prevalence of CIN3+ lesions [ Time Frame: Day 0 ]
    Prevalence of CIN3 lesions overall and by sub-groups defined by age categories, current CD4-cell count, nadir CD4-cell count and treatment history
  • Prevalence of cervical cancer [ Time Frame: Day 0 ]
    Prevalence of cervical cancer overall and by sub-groups defined by age categories, current CD4-cell count, nadir CD4-cell count and treatment history
  • Adverse events [ Time Frame: Day 0 and Week 1 up to 24 weeks ]
    Rate and nature of adverse events and protocol violations
  • Proportion of the women eligible to HPV screening who were actually screened and treated (if required) [ Time Frame: Day 0 ]
    Proportion of the women eligible for the study who were actually screened, treated (if required)
  • Evaluation of the micro-costing [ Time Frame: Day 0 up to Week 26 ]
    Evaluation of the micro-costing of the various components of the screening strategies

Estimated Enrollment: 3000
Study Start Date: February 2019
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: 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;
Diagnostic Test: 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

Eligibility

Eligibility

Ages Eligible for Study: 30 Years to 59 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Women
  • HIV-1 infection
  • Age 30 to 59 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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03789513

Contacts

Contact:   Pierre Debeaudrap, PhD (0) 1 76 53 34 53 ext +33 pierre.debeaudrap@ird.fr
Contact:   Apollinaire Horo, PhD horoapollinaire@gmail.com

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Institut de Recherche pour le Developpement
International Agency for Research on Cancer
PACCI, Abidjan, Côte d'Ivoire
University Hospital, Geneva
University of Bordeaux

Investigators

Study Director: Pierre Debeaudrap, PhD CEPED - UMR196
Study Director: Apollinaire Debeaudrap, PhD PACCI - Ivory Coast
More Information

More Information


Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
ClinicalTrials.gov Identifier: NCT03789513   History of Changes  
Other Study ID Numbers: ANRS12375  
Study First Received: September 3, 2018  
Last Updated: December 27, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

HIV infection, HPV infection, cervical cancer, screening algorithms

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.