title: Performance of careHPV for detecting high-grade cervical intraepithelial neoplasia among women living with HIV-1 in Burkina Faso and South Africa: HARP study.
abstract: The careHPV assay is a test for high-risk (HR) human papillomaviruses (HPV) detection designed to be affordable in resource-poor settings. We evaluated the performance of careHPV screening among 1052 women living with HIV/AIDS included in the HARP (HPV in Africa Research Partnership) study in Burkina Faso (BF) and South Africa (SA).
  
  
  
  Cervical samples were tested for HR-HPV by the careHPV and the INNO-LiPA HPV genotyping Extra assays. All women had Pap smear testing, visual inspection with acetic acid/Lugol's iodine (VIA/VILI) and colposcopy. Cervical biopsies were obtained for participants who were HR-HPV DNA positive by careHPV or who had abnormalities detected on cytology, VIA/VILI or colposcopy.
  
  
  
  Overall, 45.1% of women had a positive careHPV test (46.5% in BF, 43.8% in SA). The careHPV positivity rate increased with the grade of cytological lesions. Sensitivity and specificity of careHPV for the diagnosis of CIN2+ (n=60, both countries combined) were 93.3% (95% confidence interval (CI): 83.8-98.2) and 57.9% (95% CI: 54.5-61.2), respectively. Specificity increased with CD4 count. careHPV had a similar clinical sensitivity but higher specificity than the INNO-LiPA assay for detection of CIN2+.
  
  
  
  Our results suggest that careHPV testing is a reliable tool for cervical cancer screening in HIV-1-infected women in sub-Saharan Africa.
authors.affiliation: Department of Biology and Pathology, INSERM U1058 and University Hospital (CHU), Montpellier 34000, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Segondy
authors.affiliation: Department of Clinical Research, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Kelly
authors.affiliation: Centre for HIV and STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg 2131, South Africa.
authors.forename: Mahlape P
authors.initials: MP
authors.lastname: Magooa
authors.affiliation: Centre de Recherche Biomoléculaire Pietro Annigoni, Ouagadougou BP7021, Burkina Faso.
authors.forename: Florencia
authors.initials: F
authors.lastname: Djigma
authors.affiliation: Department of Biology and Pathology, INSERM U1058 and University Hospital (CHU), Montpellier 34000, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Ngou
authors.affiliation: Department of Clinical Research, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Gilham
authors.affiliation: Department of Anatomical Pathology, University of the Witwatersrand, and National Health Laboratory Service, Johannesburg 2131, South Africa.
authors.forename: Tanvier
authors.initials: T
authors.lastname: Omar
authors.affiliation: Centre de Recherche Internationale en Santé, University of Ouagadougou, Ouagadougou BP7021, Burkina Faso.
authors.forename: Olga
authors.initials: O
authors.lastname: Goumbri-Lompo
authors.affiliation: Department of Anatomical Pathology, University of the Witwatersrand, and National Health Laboratory Service, Johannesburg 2131, South Africa.
authors.forename: Pamela
authors.initials: P
authors.lastname: Michelow
authors.affiliation: Department of Biology and Pathology, INSERM U1058 and University Hospital (CHU), Montpellier 34000, France.
authors.forename: Sylviane
authors.initials: S
authors.lastname: Doutre
authors.affiliation: Infections and Cancer Unit, Catalan Institute of Oncology, Barcelona 08908, Spain.
authors.forename: Omar
authors.initials: O
authors.lastname: Clavero
authors.affiliation: Reproductive Health & HIV Institute, University of the Witwatersrand, Johannesburg 2001, South Africa.
authors.forename: Admire
authors.initials: A
authors.lastname: Chikandiwa
authors.affiliation: Centre de Recherche Internationale en Santé, University of Ouagadougou, Ouagadougou BP7021, Burkina Faso.
authors.forename: Bernard
authors.initials: B
authors.lastname: Sawadogo
authors.affiliation: Department of Biology and Pathology, INSERM U1058 and University Hospital (CHU), Montpellier 34000, France.
authors.forename: Marie-Noelle
authors.initials: MN
authors.lastname: Didelot
authors.affiliation: Department of Biology and Pathology, INSERM U1058 and University Hospital (CHU), Montpellier 34000, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Costes
authors.affiliation: Centre de Recherche Internationale en Santé, University of Ouagadougou, Ouagadougou BP7021, Burkina Faso.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Méda
authors.affiliation: Reproductive Health & HIV Institute, University of the Witwatersrand, Johannesburg 2001, South Africa.
authors.forename: Sinead
authors.initials: S
authors.lastname: Delany-Moretlwe
authors.affiliation: Department of Clinical Research, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.|Reproductive Health & HIV Institute, University of the Witwatersrand, Johannesburg 2001, South Africa.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mayaud
mesh_terms: D019342:Acetic Acid; D000328:Adult; D001706:Biopsy; D002050:Burkina Faso; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D055088:Early Detection of Cancer; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000150:complications; D015497:HIV-1; D006801:Humans; D007454:Iodides; D008875:Middle Aged; D065006:Papanicolaou Test; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013019:South Africa; D002583:Uterine Cervical Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000150:complications / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral; D007454:Iodides; D019342:Acetic Acid; C010389:Lugol's solution