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

NCT ID: NCT04614155

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-27

Study Completion Date

2025-08-08

Brief Summary

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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

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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.

Conditions

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Healthy Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (questionnaire, health education, self-collection)

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Take part in health education session

HPV Self-Collection

Intervention Type PROCEDURE

Receive HPV self-collection kit

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Educational Intervention

Take part in health education session

Intervention Type OTHER

HPV Self-Collection

Receive HPV self-collection kit

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational At-home HPV Self Collection HPV Self Collection Human Papillomavirus Self-Collection

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surendranath S Shastri

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38723214 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-04860

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-0182

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0182

Identifier Type: -

Identifier Source: org_study_id

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