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Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
N = 19,851NCT02005510
- Population
- Women aged 30 to 64 years with health plan enrolment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months and no hysterectomy.
- Design
- Randomised clinical trial in Kaiser Permanente Washington, a US integrated health care delivery system. Women were enrolled from February 25, 2014 to August 29, 2016, with follow-up through February 26, 2018. The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics); the intervention group received usual care plus a mailed HPV self-sampling kit. Two primary outcomes were CIN2+ detection within 6 months of screening and treatment within 6 months of CIN2+ detection; screening uptake within 6 months of randomization was a secondary outcome.
- Primary endpoint
- CIN2+ detection within 6 months of screening, Treatment within 6 months of CIN2+ detection
- Arms
- Usual care plus mailed HPV self-sampling kit (experimental, n = 9,960): Usual care plus a mailed HPV self-sampling kit
- Usual care reminders (control, n = 9,891): Annual patient reminders and ad hoc outreach from primary care clinics
- People
- Winer RL, senior author Buist DSM
Δ Screening uptake within 6 months of randomization+8.9 points
Show the numbers
| Endpoint | Analysis | Usual care plus mailed HPV self-sampling kit | Usual care reminders | Effect |
|---|---|---|---|---|
| Screening uptake within 6 months of randomizationAll randomised women (the abstract states that all women randomized were included in the analysis)Secondary outcome: proportion of randomised women who completed screening within 6 months of randomization. | finalWiner 2019 | 26.3% | 17.4% | 2618 participants in the intervention group and 1719 in the control group; relative risk 1.51 (95% CI 1.43-1.60). CIN2+ detection (12 vs 8 women; relative risk 1.49, 95% CI 0.61-3.64) and treatment (12 vs 7; relative risk 1.70, 95% CI 0.67-4.32) did not differ significantly. |
| Endpoint | Analysis | Usual care plus mailed HPV self-sampling kit | Usual care reminders | Effect |
|---|---|---|---|---|
| Screening uptake within 6 months of randomizationAll randomised women (the abstract states that all women randomized were included in the analysis)Secondary outcome: proportion of randomised women who completed screening within 6 months of randomization. | finalWiner 2019 | 26.3% | 17.4% | 2618 participants in the intervention group and 1719 in the control group; relative risk 1.51 (95% CI 1.43-1.60). CIN2+ detection (12 vs 8 women; relative risk 1.49, 95% CI 0.61-3.64) and treatment (12 vs 7; relative risk 1.70, 95% CI 0.67-4.32) did not differ significantly. |