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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)

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ClinicalTrials.gov Identifier: NCT03789513
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
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)

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 (30-59 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 or disease Intervention/treatment Phase
HIV Infections HPV - Anogenital Human Papilloma Virus Infection Diagnostic Test: HPV test with partial genotyping and VIA triage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Adverse events [ Time Frame: Day 0 and Week 1 up to 24 weeks ]
    Rate and nature of adverse events and protocol violations

  8. 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)

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789513


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

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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
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Infection
Communicable Diseases
HIV Infections
Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections