This clinical trial evaluates the impact of self-sampling human papillomavirus virus (HPV) testing on cervical cancer screening in the Rio Grande Valley (RGV) of Texas. Cervical cancer may be preventable through vaccination against the virus that causes it, HPV, and through screening. Screening tests, including the Papanicolaou (Pap) smear and testing for HPV, are effective in identifying those at higher risk for developing cancer. However, many people do not have access to these tests because a pelvic exam with a healthcare provider is required. Self-sampling, collecting one's own sample, for HPV testing has been shown to work as well as sampling performed by a healthcare provider and may be an effective way to increase participation in screening for cervical cancer in the RGV of Texas.
Additional locations may be listed on ClinicalTrials.gov for NCT06109870.
Locations matching your search criteria
United States
Texas
Austin
University of Texas at AustinStatus: Active
Contact: Marian Yvette Williams-Brown
Phone: 512-324-7000ext77721
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Jane Richards Montealegre
Phone: 281-814-7118
PRIMARY OBJECTIVES:
I. Determine the feasibility of community health workers-delivered self-sampling (CHW-SS) in the RGV (i.e., reach, screening uptake, notification of test results).
II. Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV.
SECONDARY OBJECTIVES:
I. Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for high-risk (HR)-HPV.
II. Evaluate contextual fit of the intervention.
OUTLINE:
Participants receive brief educational session on cervical cancer prevention and may perform self-sampling HPV testing collection with provided self-sample kit on study. Participants with negative results receive a recommendation for cervical cancer screening with a healthcare provider in one year. Participants with positive results receive referral and an appointment for diagnostic testing with colposcopy. Participants diagnosed with invasive cervical cancer receive referral to a gynecologic oncology specialist.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJane Richards Montealegre