Objectives Cervical cancer is preventable and caused by persistent infection with oncogenic human papilloma virus (HPV) types. HPV screening is more sensitive and is the preferred screening test. HPV screening data are mainly from developed settings, and the purpose of this study was to investigate the performance of HPV screening in previously unscreened HIV positive and negative women.
Methods In this cross sectional multicenter study, liquid based cytology and HPV testing were performed on women attending different clinics. Patients with positive screening tests had colposcopy and biopsy or large loop excision of the transformation zone. Some women with normal screening had colposcopy and biopsy. Data of women with histology results, and data of HIV positive and negative women were analyzed for comparison. For women without histology results, data were imputed using a statistical model.
Results In 903 women with known HIV status, 683 (75.6%) had negative cytology, 202 women (22.4%) had abnormal cytology, and in 18 patients (2.0%) the results were uncertain. Mean age was 41.4 years (range 25–65). HPV tests were negative in 621 women (68.8%). In HIV positive women, 54.5% tested negative compared with 79.7% HIV negative women (p<0.0001). HPV screening had higher sensitivity (60.9%), but lower specificity (82.4%), compared with cytology (48.6% and 86.7%) for detection of cervical intraepithelial neoplasia (CIN) 2+ in all women. For detection of CIN 3+, HPV screening had higher sensitivity (70.4%) compared with cytology (62.9%), and specificity (75.5%) was lower compared with cytology at a threshold of atypical squamous cells of undetermined significance (ASCUS+) (82.4%).
Conclusion HPV screening was more sensitive than cytology in HIV positive and HIV negative women, but specificity was lower. Although HPV screening should be the preferred screening test, cytology is a suitable screening test in HIV positive women in low resource settings.
Trial registration number NCT02956031.
- Cervix Uteri
- Genital Neoplasms, Female
Data availability statement
Data are available upon reasonable request.
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Contributors LCS: study design, investigator, analysis and data interpretation, and drafting manuscript. KLR: virology laboratory support, study design, and revising manuscript. AL: virology laboratory support, study design, and revising manuscript. GeD: statistical support, data analysis and interpretation, and revising manuscript. MHB: study design and concept, project leader Western Cape province, and revising manuscript. HvdM: study design, investigator Western Cape Province, and revising manuscript. CV: investigator, data collector, data analysis, and manuscript writing and revising. GrD: study concept, planning design, principal investigator and project coordinator, revising manuscript, and responsible for the overall content as guarantor.
Funding This study was part of the the larger DiaVACCS initiative, investigating different screening and triage strategies for women who do not have the advantage of population based cervical cancer screening. This specific arm received financial and laboratory support from QIAGEN GmbH towards sample collection and testing.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.