Healthy Subject
Conditions
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.
Interventions
OTHEREducational Intervention
Take part in health education session
PROCEDUREHPV Self-Collection
Receive HPV self-collection kit
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant consent rate | Up to 1 month | — |
| Human papillomavirus (HPV) self-collection uptake rate | Up 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical screening associated knowledge, attitudes and practices score | Up 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 years | Up to 1 month | — |
| HPV positive proportion | Up to 1 month | — |
Countries
United States
Outcome results
None listed