Human papilloma virus, illustration

Offering an at-home human papillomavirus (HPV) self-collection test plus appointment-scheduling assistance could double the uptake of cervical cancer screening among under-screened women from low-income backgrounds compared with scheduling assistance alone, suggest results of the US-based My Body, My Test-3 trial.

Self-testing for oncogenic HPV subtypes is already used in national programs in European countries such as Denmark, the Netherlands, and Sweden to increase screening rates but does not currently carry the necessary Food and Drug Administration (FDA) approval for use in the USA.

“We hope that this data will help generate more evidence for FDA approval,” said Jennifer Smith, professor of epidemiology at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

She told Inside Precision Medicine that the study “provides evidence that this intervention works among under-screened, underserved women [who have] the greatest risk of disease.”

In the USA, screening guidelines recommend women aged 21 years and older undergo cytology-based Papanicolaou testing alone every 3 years and in-clinic testing for high-risk HPV infection every 5 years, either as primary testing or in conjunction with Papanicolaou testing (co-testing) for people aged 30 years and older.

Early detection and treatment of cervical precancerous lesions through such screening have contributed to declining cervical cancer incidence and mortality rates over the last three decades. However, the Centers for Disease Control and Prevention estimates that 22% of eligible adults in the U.S. are overdue for cervical screening and most cervical cancer cases now occur in under-screened populations.

To address this, Smith and colleagues investigated whether an intervention that combined self testing for HPV with telephone assistance to help schedule in-clinic screening appointments could improve uptake.

Their Phase III trial included 665 participants from 22 counties in North Carolina who were aged 25–64 years (median 42 years), were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less than the US Federal Poverty Level (median $15,000 per year per household), and had had their last Papanicolaou test four or more years ago or high-risk HPV test six or more years ago, making them overdue for screening.

Of these, 438 were mailed an at-home HPV self-collection testing kit and received assistance for scheduling a free screening appointment; and 227 received scheduling assistance alone. Most participants with available data were Black non-Latina or non-Hispanic (47% of 664), uninsured (78% of 663), single or never married (52% of 661), and unemployed (57% of 660).

Participants who received the HPV self-collection kits were asked to collect a cervical-vaginal cell sample and return it by mail for testing. They were informed of their results by telephone. In addition, trial staff made up to three telephone call attempts to provide scheduling assistance for in-clinic screening for all participants.

Smith and team report in The Lancet Public Health that 72% of participants in the intervention group completed screening within 6 months of enrolment, as defined by attending a screening appointment at any clinic or testing negative for high-risk HPV on self-collected samples. They note that this “represents how self-collection methods would be implemented if approved for primary screening in the USA.” Participants who tested positive or invalid for high-risk HPV, or did not return a self-collection kit, were only considered to have completed screening if they attended an in-clinic screening appointment.

By comparison, screening uptake was just 37% in the group that did not receive the HPV home test, and the results were similar regardless of race/ethnicity. This is important because cervical cancer disproportionately affects Black and Hispanic women in both North Carolina and the USA as a whole. Age, time since last screening, Medicaid or Medicare insurance coverage, and education level also had no impact on the outcome.

Smith said the findings show that “we can no longer question that self-collection doesn’t work among underserved, under-screened populations.”

She also highlighted the high HPV kit return rate of 78%, which shows that the intervention is accepted by the women.

Of the participants that returned tests, 11 (3%) had invalid self-collected results and one (<1%) participant’s sample was received damaged. High-risk HPV was detected in 16% of the remaining 329 samples.

Among the 665 participants included in the primary analysis, abnormal cytology was detected in 2% of participants in each arm and follow-up colposcopies were recommended in 1% of each group.

Smith and co-authors conclude: “The results of the MBMT-3 trial and previous research support recommendations for multicomponent interventions (ie, HPV self-collection plus appointment scheduling assistance) to increase cervical cancer screening and reduce structural barriers that are often faced by under-screened women from low-income backgrounds.”

The researchers are now analyzing and planning to publish data they collected on patient acceptability of the intervention and predictors of kit return.

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