Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women

Texas State HPV Self-Collection Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Procedure: HPV Self-Collection

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.

OUTLINE:

Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.

After completion of study, participants are followed up at 1 month.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening (questionnaire, health education, self-collection); Participants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.

Other: Questionnaire Administration; Complete questionnaires; Other: Educational Intervention; Take part in health education session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: HPV Self-Collection; Receive HPV self-collection kit; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical screening associated knowledge, attitudes and practices score	Paired t-tests or Wilcoxon signed-rank tests will be used to examine the change of the scores difference for cervical screening associated knowledge, attitudes and practices. For every participant, 'Knowledge' will be measured using a 12-question scale, which will have a 'Yes/No/Unsure' response. Each 'correct' response will be scored as 1, while 'incorrect' and 'unsure' as 0. A score 50% (≥6 correct responses) will be considered as optimal. 'Attitude' will be measured using a 6-question scale which will have 'Disagree/Neutral/Agree response. Attitude will be considered as favorable if we have three or more "Agree" responses. Being screened, before our education-intervention, for cervical cancer with Pap-smear, and after our intervention either with HPV self-sampling or Pap-smear, will be regarded as having good practice. Changes in Knowledge, Attitude and Practice, pre- and post-education intervention will be examined using Paired t-tests or Wilcoxon signed-rank tests.	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Surendranath S Shastri, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): August 8, 2025

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0182 (Other Identifier: M D Anderson Cancer Center); NCI-2019-04860 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No