Acceptability and Accuracy of Cervical Cancer Screening Using a Self-Collected Tampon for HPV Messenger-RNA Testing among HIV-Infected Women in South Africa

Abstract

BackgroundHIV increases women’s risk for high-risk human papillomavirus (hrHPV) infection and invasive cervical cancer. South Africa has a high HIV prevalence but low cervical cancer screening coverage. Self-collection of cervical specimens and hrHPV testing, including hrHPV messenger-RNA (mRNA) testing, are methods aimed at increasing screening rates. However, data are limited on the acceptability and accuracy of tampon-based self-collection for hrHPV mRNA testing in HIV-infected women.MethodsWe recruited 325 HIV-infected women seeking care at a government HIV clinic in Pretoria, South Africa. A clinician performed a pelvic examination and obtained an endocervical specimen. Study participants performed self-collection using a tampon. Both clinician- and self-collected specimens were tested for hrHPV mRNA. Acceptability of both collection methods was assessed, the prevalence of hrHPV mRNA in our study population was estimated, test positivity of the two collection methods were compared, and test agreement was assessed by calculating the κ-statistic, sensitivity, and specificity.ResultsOver 90% of women reported no difficulties self-collecting specimens and 82% were willing to perform the tampon-collection at home. Based on clinician-collection specimens, the prevalence of hrHPV mRNA in our study population was 36.7% (95% CI: 31.4%– 42.0%). There was no difference in test positivity between clinician-collection, 36.7%, and tampon-collection, 43.5% (p-value = 0.08). Using clinician-collection as the reference test, the sensitivity and specificity for hrHPV mRNA of tampon-collection were 77.4% (95% CI: 69.8–85.0%) and 77.8% (95% CI: 71.9–83.6%), respectively.ConclusionsTampon-based self-collection is acceptable to women and has similar hrHPV mRNA positivity rates as clinician-collection, but has reduced sensitivity and specificity compared to clinician-collection. The hrHPV mRNA prevalence in our study population is high, but similar to other high-risk populations, and highlights the need for improved cervical cancer screening. Further research into the optimal use of tampon-based collection as a cervical cancer screening tool is warranted.

High‐risk HPV‐RNA screening of physician‐ and self‐collected specimens for detection of cervical lesions among female sex workers in Nairobi, Kenya

“…The present results were comparable to those from three similar cross-sectional studies that compared hrHPV-RNA detection in self-and physician-collected specimens among women in South Africa (κ=0.54), Nepal (κ=0.62), and Canada (κ=0.63). [14][15][16] The accuracy of hrHPV-RNA testing for detection of HSIL+ was similar for self-and physician-collected specimens over 12 months.…”

A systematic review of self‐sampling for HPV testing in Africa

“…In total, 13 of the included studies were cohort studies, and 8 reported cross‐sectional findings in eligible populations.…”

“…The non‐randomized studies recruited populations with different characteristics. For example, Viviano et al., Adamson et al., and Rositch et al . enrolled women with HIV in a cohort study; Toliman et al .…”

“…In 15 non‐randomized studies, HPV tests on self‐ and clinician‐collected samples were compared. Six studies evaluated self‐sampling by an interviewer‐administered questionnaire, and one compared self‐collected vaginal samples for HPV testing between women in a rural setting and those in an urban setting …”

Participation in Cervical Screening by Self-collection, Pap, or a Choice of Either in Brazil

“…Most studies of self-collection in low-and middleincome countries (LMIC) have not evaluated actual patient preferences, as measured by screening adherence. Rather, studies in LMICs have had enrolled, consenting women undergo self-collection with or without also getting a provider-collected specimen and then relied on questionnaires and interviews to understand the acceptability/ patient preferences for self-collection (11)(12)(13)(14). As an exception, in a randomized trial of almost 6,000 women in Argentina, women offered self-collected sampling were 4-fold more likely to complete screening compared with those who were offered clinic-based provider-collected sampling for cytology (86% vs. 20%, respectively; ref.…”