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

Healthy Subject Clinical Trial

Official title:

Texas State HPV Self-Collection Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04614155
• Other study ID #: 2019-0182
• Secondary ID: NCI-2019-0486020
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• Educational Intervention
Take part in health education session

Procedure:
• HPV Self-Collection
Receive HPV self-collection kit

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant consent rate		Up to 1 month
Primary	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	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
Secondary	Participants' self-reported Pap smear screening rate in last 3 years		Up to 1 month
Secondary	HPV positive proportion		Up to 1 month

External Links

•   University of Texas MD Anderson Cancer Center Website