Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women
Texas State HPV Self-Collection Pilot Study
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedAugust 12, 2025
August 1, 2025
6 years
October 26, 2020
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Participant consent rate
Up to 1 month
Human papillomavirus (HPV) self-collection uptake rate
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.
Up to 2 weeks after health education session
Secondary Outcomes (3)
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
HPV positive proportion
Up to 1 month
Study Arms (1)
Screening (questionnaire, health education, self-collection)
EXPERIMENTALParticipants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.
Interventions
Take part in health education session
Receive HPV self-collection kit
Complete questionnaires
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Self-reported hysterectomy.
- Self-reported personal history of cancer/cancer diagnosis.
- Self-reported as pregnant.
- Another household member is enrolled in this protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Shastri SS, McNeill LH, Shete S. Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women. JCO Glob Oncol. 2024 May;10:e2400005. doi: 10.1200/GO.24.00005.
PMID: 38723214DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surendranath S Shastri
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 3, 2020
Study Start
August 27, 2019
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
August 12, 2025
Record last verified: 2025-08