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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
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
- 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
- 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
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
|Contact: Pierre Debeaudrap, PhD||(0) 1 76 53 34 53 ext +firstname.lastname@example.org|
|Contact: Apollinaire Horo, PhDemail@example.com|
|Study Director:||Pierre Debeaudrap, PhD||CEPED - UMR196|
|Study Director:||Apollinaire Debeaudrap, PhD||PACCI - Ivory Coast|