Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 30 - 64 |
| Updated: | 5/5/2018 |
| Start Date: | February 2014 |
| End Date: | February 2018 |
The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV)
screening kits is effective in increasing uptake of cervical cancer screening and early
detection and treatment of cervical neoplasia in underscreened women.
screening kits is effective in increasing uptake of cervical cancer screening and early
detection and treatment of cervical neoplasia in underscreened women.
Over half of all cervical cancers in the U.S. are diagnosed in unscreened or underscreened
women. New national guidelines identify increasing screening uptake as the number one
priority for reducing cervical cancer-related morbidity and mortality. Innovative screening
strategies that eliminate the need for clinic-based screening could be highly effective in
improving screening compliance while maintaining high-quality care. We propose a large,
pragmatic randomized controlled trial within Group Health (a large integrated health care
delivery system in Washington State) to compare effectiveness of two programmatic approaches
to increasing cervical cancer screening among overdue women. The first approach (control arm)
is usual care at Group Health, which consists of patient- and provider-level services to
promote adherence to Pap screening, and the second approach (intervention arm) includes usual
care plus a mailed in-home high-risk human papillomavirus (hrHPV) screening kit. We will
randomize eligible women to the in-home hrHPV screening arm or the usual care arm. Compared
to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and
treatment of cervical neoplasia and improve compliance with screening. The trial will provide
definitive evidence-based data on the impact of an in-home hrHPV screening program in a
real-world clinical setting.
women. New national guidelines identify increasing screening uptake as the number one
priority for reducing cervical cancer-related morbidity and mortality. Innovative screening
strategies that eliminate the need for clinic-based screening could be highly effective in
improving screening compliance while maintaining high-quality care. We propose a large,
pragmatic randomized controlled trial within Group Health (a large integrated health care
delivery system in Washington State) to compare effectiveness of two programmatic approaches
to increasing cervical cancer screening among overdue women. The first approach (control arm)
is usual care at Group Health, which consists of patient- and provider-level services to
promote adherence to Pap screening, and the second approach (intervention arm) includes usual
care plus a mailed in-home high-risk human papillomavirus (hrHPV) screening kit. We will
randomize eligible women to the in-home hrHPV screening arm or the usual care arm. Compared
to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and
treatment of cervical neoplasia and improve compliance with screening. The trial will provide
definitive evidence-based data on the impact of an in-home hrHPV screening program in a
real-world clinical setting.
Inclusion Criteria:
- Female
- 30 to 64 years of age
- Have a primary care provider at Group Health
- Received annual "birthday letter" with Pap screening reminder 5 months earlier
- No Pap test in the past 3.4 years
- Continuously enrolled at Group Health for at least 3.4 years
- No hysterectomy
Exclusion Criteria:
- Currently pregnant
- Language interpreter needed
- On "do not contact list" for research studies
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