Triage of Women Testing Positive With the careHPV Test on Self-Collected Vaginal Samples for Cervical Cancer Screening in a Low-Resource Setting.

PURPOSE: Human papillomavirus (HPV) DNA screening reduces cervical cancer incidence and mortality in low-resource settings. Self-collected vaginal samples tested with affordable HPV tests such as careHPV can increase the rate of screening in resource-constrained settings. We report the role of visual inspection with acetic acid (VIA) as a triage test for women testing positive with the careHPV test on self-collected vaginal samples.

METHODS: As part of a multicountry demonstration study, 5,207 women 30 to 49 years of age were recruited from urban slums to undergo four cervical screening tests using the careHPV test on self-collected vaginal samples, provider-collected cervical samples, the Papanicolaou test, and VIA. All women who tested positive for any of the screening tests were evaluated with colposcopy and guided biopsies, followed by treatment if any cervical lesions were detected. The data from the 377 women who tested positive for HPV in the self-collected vaginal samples were also analyzed to assess the performance of VIA, conventional cytology, and colposcopy, as triage tests in the detection of cervical cancer and precancerous lesions.

RESULTS: Nineteen percent of women who tested positive for vaginal HPV (V-HPV) also tested positive with the VIA test; cervical intraepithelial neoplasia 2+ lesions were detected in 58% of these women. In the 30 % of the women who tested positive for V-HPV with cytology triage, cervical intraepithelial neoplasia 2+ lesions were detected in 80% of these women. The colposcopy referrals for women who tested positive for V-HPV were reduced from 7.6% to 1.5% by VIA triage, and to 2.3% by cytology triage. Although the sensitivity was reduced, the positive predictive value improved after triage with VIA and cytology.

CONCLUSION: This study reflects the optimal role of VIA triaging for treatment selection of lesions among those who test positive for V-HPV in screen and treat screening programs that use an HPV test in low-resource settings.