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

Not Applicable
Active, not recruiting
Conditions
Healthy Subject
Interventions
Other: Educational Intervention
Procedure: HPV Self-Collection
Other: Questionnaire Administration
Registration Number
NCT04614155
Lead Sponsor
M.D. Anderson Cancer Center
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
40
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Screening (questionnaire, health education, self-collection)Questionnaire AdministrationParticipants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.
Screening (questionnaire, health education, self-collection)Educational InterventionParticipants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.
Screening (questionnaire, health education, self-collection)HPV Self-CollectionParticipants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.
Primary Outcome Measures
NameTimeMethod
Human papillomavirus (HPV) self-collection uptake rateUp to 2 weeks after health education session

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.

Participant consent rateUp to 1 month
Secondary Outcome Measures
NameTimeMethod
HPV positive proportionUp to 1 month
Cervical screening associated knowledge, attitudes and practices scoreUp to 1 month

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.

Participants' self-reported Pap smear screening rate in last 3 yearsUp to 1 month

Trial Locations

Locations (1)

M D Anderson Cancer Center

🇺🇸

Houston, Texas, United States

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