Mailing at-home HPV sampling kits nearly doubles cervical screening uptake among hard-to-reach populations, US clinical trial suggests

At-home high-risk human papillomavirus (hrHPV) sampling kits can help increase cervical cancer screening among under-screened women from low-income backgrounds, according to findings from a US-based clinical trial published in The Lancet Public Health journal.

The trial shows mailing kits to low-income, under-screened women and helping them book an in-person clinic appointment led to a two-fold increase in screening uptake compared to only offering assistance making an appointment.

The main cause of cervical cancer is persistent infection with a hrHPV, which puts women at risk of developing precancerous cervical lesions. Cervical cancer disproportionately affects Black and Hispanic women in the USA, with the highest incidence among Hispanic women and the highest mortality among Black women. Regular hrHPV testing in accordance with national screening guidelines reduces the risk of women developing the disease.

Current US guidelines on cervical cancer screening have several options. For women 21 years and over, a Papanicolaou (Pap) test every three years is recommended. For those 30 years and older, additional options include HPV cytology co-testing every five years or primary hrHPV testing every five years.

While previous studies have shown hrHPV self-collection kits can help increase cervical cancer screening, little research has involved under-screened women in the USA. Limited data is available on the combined effectiveness of using hrHPV self-collection kits and offering help scheduling in-person screening appointments.

Lead author Professor Jennifer S. Smith, University of North Carolina at Chapel Hill, US, said: “Until now, most studies of whether HPV self-collection increases cervical cancer screening have been outside the USA, in countries with national screening registries and universal health care. Our findings suggest programmes that use mailed HPV kits with effective community outreach can greatly improve screening uptake among underserved, at-risk women in the USA.” [1]

The authors conducted a randomised clinical trial involving 665 under-screened women in 22 counties in North Carolina, USA. Intensive community outreach campaigns – including printed and radio advertisements, online postings, community events and organisations and via a social assistance helpline – were used to recruit participants from underserved, under-screened groups and of racial and ethnic diversity.

The average age of participants in the trial – called My Body My Test-3 – which ran from 2016 to 2019, was 42 years, and more than half self-reported as Black or Hispanic (55%, 365/664 participants), uninsured (78%, 518/663), or unemployed (57%, 373/660). Women were only eligible for the trial if they had not received a Pap test in four years or more, or an hrHPV test in six years or more.

Participants were either sent hrHPV self-collection kits and given help booking an in-person appointment, or only given help making an appointment. The main outcome was cervical cancer screening uptake within 6 months of enrolment, defined as a negative hrHPV test result or attending an in-person screening appointment. Participants who tested positive for hrHPV by self-collection were referred to in-clinic appointment for further tests.

For participants who received mailed kits and help scheduling an appointment, cervical cancer screening uptake was almost double (72%, 317/438 participants) compared to those who received scheduling assistance only (37%, 85/227 participants). The benefits of home testing were similar regardless of participants’ age, time since last screening, race/ethnicity, insurance coverage, or level of education.

Among participants sent hrHPV kits, more than three quarters (78%, 341/438 participants) returned a sample. Valid hrHPV results were obtained for 329 participants, of whom 52 (16%) tested positive for hrHPV and were referred for follow-up appointments that 22 (42%) attended. Further tests detected CIN2+ lesions – which can progress to cervical cancer – in two (<1%) participants, who then received treatment.

Second author Dr Noel Brewer, of the University of North Carolina at Chapel Hill, said: “Government approval of at-home HPV tests would have a huge impact. We could better reach those in rural areas where cervical cancer screening is hard to come by. Also, only the people who self-test positive would need to go to a clinic for screening. For the many Americans without reliable access, cervical cancer screening from home would ensure they can get life-saving preventive care.” [1]

The authors acknowledge some limitations to their study. While the outreach approach used may oversample more motivated women and somewhat limit the study’s generalisability, it enabled recruitment of large numbers of at-risk women from the general population who do not regularly use clinic services. Mailed hrHPV kits do not meet the needs of all under-screened, hard-to-reach women. Consistent with other studies, less than half of participants with positive hrHPV results attended an in-clinic appointment, highlighting the need for further efforts to ensure continuity to care among those with positive self-test results. The trial was also conducted prior to the COVID-19 pandemic, so effects on screening uptake in the post-pandemic era could not be determined.

Writing in a linked Comment, Runzhi Wang, MD, and Jenell Coleman, MD, of Johns Hopkins University School of Medicine, who were not involved in the study, said: “This study provides the required evidence that high-risk HPV testing on self-collected samples can be an effective strategy for hard-to-reach populations.” They also call for developments to optimise the entire cervical cancer prevention process in the USA, saying: “Optimisation includes policy reforms to remove financial barriers to diagnostic tests and treatment; community outreach and education campaigns; and improved access to quality care through transportation services, expanded Medicaid eligibility, and skilled clinicians.”

https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(23)00076-2/fulltext