Clinical trial NCT03789513: Evaluation of Triage Options After HPV Testing for Cervical Cancer Screening Among HIV-infected Women
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
HPV - Anogenital Human Papilloma Virus Infection
Keywords: HIV infection, HPV infection, cervical cancer, screening algorithms
recurrence
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche pour le Developpement
name: International Agency for Research on Cancer
name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
name: University Hospital, Geneva
name: University of Bordeaux
First posted: 2018-12-28
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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)

Primary outcomes:
measure: Sensitivity of the triage options
timeFrame: Day 0
measure: Specificity of the triage options
timeFrame: Day 0
Secondary outcomes:
measure: Positive and negative predictive value (PPV and NPV) of the triage options
timeFrame: Day 0
measure: Positive and negative diagnostic likelihood ratio (DLR) of the triage options
timeFrame: Day 0
measure: Acceptability and feasibility
timeFrame: Day 0 and Week 1
measure: Prevalence of CIN2+ lesions
timeFrame: Day 0
measure: Prevalence of CIN3+ lesions
timeFrame: Day 0
measure: Prevalence of cervical cancer
timeFrame: Day 0
measure: Adverse events
timeFrame: Day 0 and Week 1 up to 24 weeks
measure: Proportion of the women eligible to HPV screening who were actually screened and treated (if required)
timeFrame: Day 0
measure: Evaluation of the micro-costing
timeFrame: Day 0 up to Week 26
measure: Evaluation of post-treatment HPV clearance
timeFrame: Week 24 and 48 post treatment
measure: Evaluation of post-treatment cervical lesion
timeFrame: Week 48 post treatment
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: HIV day care center
city: Phnom Penh
country: Cambodia
facility: Calmette Hospital
city: Abidjan
country: Côte D'Ivoire
facility: CEPREF
Study officials:
affiliation: Ceped UMR 196
name: Pierre Debeaudrap, PhD
role: STUDY_DIRECTOR
affiliation: PACCI - Ivory Coast
name: Apollinaire Debeaudrap, PhD
role: STUDY_DIRECTOR
References: