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| - Abstract Objective To assess the validity, reliability, and acceptability of self-collected HPV tests in U.S. women living with HIV (WLHIV). Methods WLHIV ≥ age 30 years underwent self-collected (clinic and home) and clinician-collected HPV tests. Sensitivity and specificity analyses were performed using clinician-collected HPV test as the comparator. Unweighted kappa statistic evaluated validity and reliability of self-collected HPV test, and level of agreement between clinician-collected mRNA test and an DNA test that was used for routine care. A 13-question survey assessed acceptability. Results Among 70 participants, median age was 50, 75% had an undetectable HIV RNA, and 11% had a CD4 count <200. Nearly 63% had at least one positive HPV test. The sensitivity and specificity for the self-collected HPV test were 84.6% (95% CI: 65.1%, 95.6%) and 62.9% (95% CI: 44.9%, 78.5%), respectively; κ = 0.5 (95% CI: 0.2, 0.7). The agreement between the two self-collected tests was good (κ = 0.8, 95% CI: 0.5, 1,0). There was good agreement between clinician-collected mRNA tests and DNA tests (κ = 0.8, 95% CI: 0.7, 1.0). Self-collection was highly acceptable. Conclusions Among WLHIV, self-collected HPV tests had good sensitivity and moderate specificity compared to clinician-collected HPV tests. The reliability between self-collected testing locations was good. Self-collected HPV testing had high acceptability.
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