Cervix Cancer, Screen HPV-positive
Conditions
Keywords
Screening, rural, outreach, high risk
Brief summary
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.
Detailed description
The RE-AIM framework will be applied to selected domains to assess feasibility using predefined parameters. Quantitative surveys will measure acceptability of intervention components among women and community partners, and qualitative interviews will explore their experiences with the intervention. The RE-AIM framework is a comprehensive tool for evaluating public health and community-based interventions. It focuses on five key dimensions: Reach, which assesses the number, proportion, and representativeness of individuals who participate in a program; Effectiveness, which measures the impact of the intervention on important outcomes, including potential negative effects; Adoption, which examines the number and representativeness of settings or staff that implement the program; Implementation, which evaluates how well the intervention is delivered as intended, including consistency and costs; and Maintenance, which considers the sustainability of both the intervention and its effects over time at individual and organizational levels.
Interventions
DIAGNOSTIC_TESTHuman papilloma virus screening
Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
100 woman and 12 community partners will be enrolled.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Woman participants Inclusion Criteria: * 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
Exclusion criteria
* 65 years of age or older had a hysterectomy, * history of cervical cancer, * plan to move from Lenoir County during the study period. Community partners participants Inclusion Criteria: * community health workers * clinic staff * community-based organization staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment and enrollment rate | Up to 6 months | Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County. |
| Retention rate | Up to 6 months | Ratio of returned HPV self-collection kits to kits distributed, and rate of participant withdrawal or loss to follow-up. |
| HPV positive screening rate | Up to 6 months | Rate of HPV-positive screening rate among woman started study will be reported. |
Contacts
CONTACTLisa Mansfield, PhD, RN
PRINCIPAL_INVESTIGATORLisa Mansfield, PhD, RN
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed