Texas State HPV Self-Collection Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Human papillomavirus (HPV) self-collection uptake rate
Study Overview
Brief Summary
This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.
Detailed Description
PRIMARY OBJECTIVES:
I. To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.
SECONDARY OBJECTIVES:
I. Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.
II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Self-identify as African American or Hispanic women.
- •Valid home address reflective of residence in the participating housing development(s) at least 50% of the time.
- •Functioning telephone number.
- •Speak and read English or Spanish.
Exclusion Criteria
- •Self-reported hysterectomy.
- •Self-reported personal history of cancer/cancer diagnosis.
- •Self-reported as pregnant.
- •Another household member is enrolled in this protocol.
Outcomes
Primary Outcomes
Human papillomavirus (HPV) self-collection uptake rate
Time Frame: Up to 2 weeks after health education session
Defined as the proportion of the participants who consent to the study and receive an HPV self-collection kit complete the self-collection and return the sample to the lab or research staff member or community health worker within timeline.
Participant consent rate
Time Frame: Up to 1 month
Secondary Outcomes
- HPV positive proportion(Up to 1 month)
- Cervical screening associated knowledge, attitudes and practices score(Up to 1 month)
- Participants' self-reported Pap smear screening rate in last 3 years(Up to 1 month)