HPV
Conditions
Brief summary
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.
Detailed description
Primary Objectives: The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas. The specific aims of this protocol are to: Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results). Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas. Secondary Objectives: Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV. Exploratory Aim 4: Evaluate contextual fit of the intervention.
Interventions
BEHAVIORALPRECEDE-PROCEED
delivered self-sampling (CHWSS) to increase screening participation.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Currently resident in RGV or other low-resource community in Texas * Stated willingness to comply with all study procedures * Females; Age ≥25 years * Have no history of hysterectomy with removal of the cervix * Have no history of cervical cancer or high-grade dysplasia * Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: * Unable to communicate in English or Spanish * Lack valid telephone contact information * Report being currently pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average 1 year. |
Countries
United States
Contacts
CONTACTJane Montealegre, M D
PRINCIPAL_INVESTIGATORJane Montealegre, M D
M.D. Anderson Cancer Center
Outcome results
None listed