Clinical trial NCT02651883: Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
Official title: Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Uterine Cervical Neoplasms
Human Papillomavirus
Keywords: Cervical cancer screening
HPV testing
Self-collection
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-11
Enrollment: 665
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.

Detailed description: Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.

This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).

Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.

Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.

Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 25 to 64 years old
* Living at ≤250% of the federal poverty line
* Eligible to receive cervical cancer screening from a study-associated clinic
* Resides within the same or bordering county of a study-associated clinic

Exclusion Criteria:

* Completion of cervical Pap screening in preceding 4 years
* Completion of HPV testing in preceding 6 years
* Pregnant
* History of hysterectomy
* Private insurance
* Unable to provide informed consent

Primary outcomes:
measure: Percent of participants that complete cervical cancer screening
timeFrame: Six months after enrollment
Secondary outcomes:
measure: Levels of risk appraisal with regards to cervical cancer and screening
timeFrame: 1-5 weeks after completion of self-collection or screening invitation
measure: Costs to payers
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Level of intention to complete cervical cancer screening
timeFrame: 1-5 weeks after completion of self-collection or screening invitation
measure: Level of self-efficacy to complete cervical cancer screening
timeFrame: 1-5 weeks after completion of self-collection or screening invitation
measure: Percentage of participants who schedule a clinic appointment to get cervical cancer screening
timeFrame: 1-5 weeks after completion of self-collection or screening invitation
Other outcomes:
measure: Percentage of participants achieving primary outcome in different demographic categories
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Prevalence of HPV mRNA (messenger ribonucleic acid) detection in self- and clinic-collected samples, abnormal cytology detected in clinic samples, and high-grade lesions (CIN2+) as detected in follow-up colposcopy screening (as indicated)
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Percentage of patients referred to and completing colposcopy
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Number of patients referred to and completing colposcopy
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Number of patients referred to and completing treatment
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Percentage of patients referred to and completing treatment
timeFrame: Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
measure: Attitudes towards HPV, cervical cancer, and cervical cancer screening
timeFrame: 1-5 weeks after completion of self-collection or screening invitation
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Gillings School of Public Health
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Jennifer S Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biddell CB, Spees LP, Smith JS, Brewer NT, Des Marais AC, Sanusi BO, Hudgens MG, Barclay L, Jackson S, Kent EE, Wheeler SB. Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women. J Womens Health (Larchmt). 2021 Sep;30(9):1243-1252. doi: 10.1089/jwh.2020.8807. Epub 2021 Apr 13.
citation: Spees LP, Des Marais AC, Wheeler SB, Hudgens MG, Doughty S, Brewer NT, Smith JS. Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):788. doi: 10.1186/s13063-019-3959-2.