About this trial
The purpose of this study is to test the feasibility and acceptability of a multi-level, community-engaged intervention to increase access to cervical cancer screening using human papillomavirus (HPV) self-collection (HPVSC) outreach among women living in a high-risk rural county and to improve navigation for follow-up screening.
A one-group intervention evaluation design will be used to pilot test feasibility and acceptability and to assess the proportion of women who return HPVSC kits and test HPV-positive. At the community level, local community-based organizations (CBOs) will serve as HPVSC kit distribution sites. At the individual level, trained community health workers will work with CBOs to support women throughout the HPVSC process, including specimen collection, kit return, result notification, and follow-up clinic-based screening for women who test HPV-positive.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Resident of Lenoir County and 12 community.
have not received a Pap test within the last 3.5 years, or an HPV test in the last 5.5 years
female ≥ 30 to 64 years of age at time of recruitment
Disqualifiers
65 years of age or older had a hysterectomy,
history of cervical cancer,
plan to move from Lenoir County during the study period.
community health workers
Trial design
Single group
Treatments tested in this trial
Human papilloma virus screening
Diagnostic testHuman papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment and enrollment rate
Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.
Retention rate
Ratio of returned HPV self-collection kits to kits distributed, and rate of participant withdrawal or loss to follow-up.
HPV positive screening rate
Rate of HPV-positive screening rate among woman started study will be reported.
Locations
Sponsors and contacts
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: