Offering universal human papillomavirus (HPV) self-testing in primary care was both non-inferior and superior to clinician-sampled Pap smear.Underscreened and marginalized groups saw the most benefit, with a significantly greater proportion screened under the intervention versus usual care.The researchers said this intervention increases equity in cervical cancer screening.

Offering human papillomavirus (HPV) self-testing in primary care appears to boost cervical cancer screening rates compared with usual care, a cluster-randomized trial in New Zealand showed.

A significantly larger proportion of people in the intervention group were screened compared with usual care (35.6% vs 24.9%) for an absolute risk difference of 10.8% (P=0.0006), showing both non-inferiority and superiority, reported Bev Lawton, MBChB, of the Te Tātai Hauora o Hine — National Centre for Women’s Health Research at Victoria University of Wellington in New Zealand, and colleagues.

The approach achieved superior screening coverage for Māori people (34.6% versus 22.3%; absolute risk difference 12.2%, P<0.0001) as well as non-Māori people, they reported in The Lancet Obstetrics, Gynaecology, & Women’s Health.

It also led to increased screening among those who had never been screened; hadn’t been screened in 4 or more years; and those who were living in areas of medium or high deprivation, they noted.

“This study confirmed that a universal offer of HPV self-testing increases equity in screening by increasing coverage for Māori people, under-screened people, and those living in areas of high deprivation,” Lawton and colleagues wrote.

HPV self-tests are becoming increasingly popular in the U.S. over cervical cytology, which uses a speculum that many patients dread. HPV self-testing, approved by the FDA in 2024, has been endorsed by the U.S. Preventive Services Task Force, the American Cancer Society, and the Health Resources and Services Administration.

Past research has shown that offering HPV self-testing to underscreened groups increases screening coverage. In New Zealand, where this study took place, Māori women are twice as likely as non-Māori women to die from cervical cancer and are less likely to be screened. Plus, the COVID era worsened these inequities, the researchers said.

“What is not known is whether offering an HPV self-test as the primary screening method, rather than to underscreened people only, in a practice setting will achieve non-inferior and equitable screening coverage compared with offering cervical sampling by vaginal speculum examination,” they wrote.

A sensitivity analysis adjusting for age, ethnicity, deprivation index, and screening status confirmed the robustness of the primary outcome (adjusted OR 1.74, P<0.0001), they added.

This cluster-randomized, non-inferiority trial took place at 14 primary care practices in New Zealand’s Northland Region. The practices were randomly assigned 1:1 to either self-testing or clinician-taken cytology by vaginal speculum examination.

Universal offer of HPV self-testing involved community engagement, practice-level training, identifying key clinician champions, as well as ongoing education and support for practices. If the patient declined, they were offered clinician-taken sampling; while two-thirds accepted HPV self-testing, a third of participants in the intervention group ended up having a clinician-taken cervical specimen.

The study, conducted from February 2022 to September 2023, included women and people with a cervix between ages 24.5 and 69.9 who were due or overdue for cervical screening. In all, 22,511 people were included in the final analysis, of whom 47.7% were in the intervention group and 52.3% were in the comparison group. Mean participant age was 47.7 and 43.4% of participants were Māori.

The study was limited by not knowing patients’ history of previous cervical abnormality.