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

M.D. Anderson Cancer Center40 enrolled

Overview

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.

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Healthy Subject

Interventions

Educational InterventionOTHER

Take part in health education session

HPV Self-CollectionPROCEDURE

Receive HPV self-collection kit

Questionnaire AdministrationOTHER

Complete questionnaires

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Participant consent rate

Time frame: 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.

Time frame: Up to 2 weeks after health education session

Secondary Outcomes

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.

Time frame: Up to 1 month

Participants' self-reported Pap smear screening rate in last 3 years

Time frame: Up to 1 month

HPV positive proportion

Time frame: Up to 1 month

Data from ClinicalTrials.gov

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