A clinical trial of 665 unscreened women in North Carolina (USA) investigated the use of high-risk human papillomavirus (hrHPV) self-collection kits to increase cervical cancer screening uptake .
Uptake of screening among participants who received self-collection kits and support to attend an in-person appointment was nearly twice as high ( 72%) as uptake of cervical cancer screening where they only received appointment assistance (37%).
More than three-quarters (78%) of these disadvantaged participants who were mailed an hrHPV kit returned a sample, suggesting that effective community outreach plays a key role in increasing uptake of the screening among women at increased risk of cervical cancer.
The authors say their findings, along with those from previous studies, provide evidence that HPV self-collection kits have the potential to increase uptake of cervical cancer screening in unscreened women.
Home high-risk human papillomavirus (hrHPV) sampling kits may help increase cervical cancer screening among low-income women who do not undergo screening, clinical trial finds US-based. Published in The Lancet Public Health journal .
Trial shows that mailing kits to low-income women who have not been adequately screened and helping them schedule an in-person clinic appointment led to a twofold increase in screening uptake compared to just offering scheduling assistance an appointment.
The main cause of cervical cancer is persistent infection with a high-risk HPV, which puts women at risk of developing precancerous cervical lesions.
Cervical cancer disproportionately affects black and Hispanic women in the US, with the highest incidence among Hispanic women and the highest mortality among black women. Regular hrHPV testing according to national screening guidelines reduces women’s risk of developing the disease.
Current US guidelines on cervical cancer screening have several options. For women age 21 and older, a Papanicolaou (Pap) test is recommended every three years. For people over 30 years of age, additional options include co-testing for HPV cytology every five years or primary testing for high-risk HPV every five years.
While previous studies have shown that hrHPV self-collection kits can help increase cervical cancer screening, little research has involved undertested women in the US. Limited data are 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, from the University of North Carolina at Chapel Hill, US, said: “So far, most studies on whether HPV self-collection increases breast cancer detection cervical screening have been performed outside the US, in countries with national screening registries and universal screening. health care. “Our findings suggest that programs using mailed HPV kits with effective community outreach can greatly improve screening uptake among underserved and at-risk women in the US.”
The authors conducted a randomized clinical trial involving 665 unselected women in 22 counties in North Carolina, USA. Intensive community outreach campaigns were used, including print and radio advertisements, online publications, events, and organizations. and through a social assistance helpline, to recruit participants from underserved, underselected, and racially and ethnically diverse groups.
The average age of participants in the trial, called My Body My Test-3 , which ran from 2016 to 2019, was 42 years old, 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 had a Pap test in four years or more, or an HPV test in six years or more.
Participants were sent hrHPV self-collection kits and were provided help scheduling an in-person appointment, or were only provided help scheduling an appointment. The primary outcome was uptake of cervical cancer screening within 6 months of enrollment, defined as a negative high-risk HPV test result or attending an in-person screening appointment. Participants who tested positive for hrHPV by self-collection were referred to an in-clinic appointment for further testing.
For participants who received mailed kits and help scheduling an appointment, cervical cancer screening uptake was nearly twice as high (72%, 317/438 participants) compared to those who only received scheduling assistance (37%, 85/227 participants). The benefits of home testing were similar regardless of participants’ age, time since last test, race/ethnicity, insurance coverage, or education level.
Among participants who were 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 attended by 22 (42%). Further testing detected CIN2+ lesions, which can progress to cervical cancer, in two (<1%) participants, who then received treatment.
Second author Dr Noel Brewer, from the University of North Carolina at Chapel Hill, said: “Government approval of at-home HPV testing would have a huge impact. We could better reach people in rural areas where cervical cancer screening is difficult. Additionally, only people who self-tested positive would have to go to a clinic to get tested. For the many Americans who do not have reliable access, cervical cancer screening at home would ensure they can get life-saving preventative care.”
The authors acknowledge some limitations of their study. Although the outreach approach used may oversample more motivated women and somewhat limit the generalizability of the study, it allowed for the recruitment of a large number of at-risk women from the general population who do not use clinical services regularly. Mailed hrHPV kits do not meet the needs of all hard-to-reach and under-screened women.
Consistent with other studies, less than half of participants testing positive for high-risk HPV attended a clinic appointment, highlighting the need for more efforts to ensure continuity of care among those testing positive in the self-test. The trial was also conducted before the COVID-19 pandemic, so the 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 the Johns Hopkins University School of Medicine, who were not involved in the study, said: "This study provides the required evidence that HPV testing “High-risk drive-thru samples may be an effective strategy for hard-to-reach populations.” They also call for developments to optimize the entire cervical cancer prevention process in the U.S., saying: “Optimization includes policy reforms to remove financial barriers to diagnostic testing and treatment; community outreach and education campaigns; and improved access to quality care through transportation services, expanded Medicaid eligibility, and qualified physicians.”
Added value of this study
The primary objective of the My Body, My Test-3 trial was to evaluate the effectiveness of mailed at-home HPV self-collection kits with scheduling assistance as a multicomponent intervention to improve uptake of HPV screening. Cervical cancer among unscreened low-income women. income history in the US, a data-poor population and region. This goal is of particular importance given that low socioeconomic status is associated with lower screening rates. Additionally, we use intensive community outreach campaigns to recruit participants from underselected and hard-to-reach populations. Screening acceptance was defined as attending a screening appointment at any clinic or testing negative for high-risk HPV in self-collected samples. This definition differs from previous trials that defined acceptance as participation in self-collection (i.e., returning a self-collection kit) or considered self-collected results that were positive for HPV 16 or HPV 18 as acceptance of screening regardless of the follow-up in the clinic. -above.
Implications of all available evidence
Mailed HPV self-collection testing has the potential to increase uptake of cervical cancer screening among women who do not undergo screening.
This study was funded by the US National Institutes of Health. It was conducted by researchers at the University of North Carolina at Chapel Hill.
