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

Study Overview
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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.

Official Title
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Texas State HPV Self-Collection Pilot Study

Conditions
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Healthy Subject

Intervention / Treatment
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* Other: Educational Intervention
* Procedure: HPV Self-Collection
* Other: Questionnaire Administration


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (questionnaire, health education, self-collection)<br>Participants complete questionnaires, take part in a health education session, and receive HPV self-collection kit. | Other: Educational Intervention<br>* Take part in health education session<br>* Other names: Intervention, Educational;Procedure: HPV Self-Collection<br>* Receive HPV self-collection kit<br>* Other names: Human Papillomavirus Self-Collection;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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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 |