Clinical trial NCT04927494: Cervical Cancer Prevention for Black Adults
Official title: Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer screening
HPV self-sampling
African American
Sub-Saharan African immigrants
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this study is to develop and pilot test an intervention, entitled Health is Wealth: A Cervical Health Program, designed to promote screening and reduce perceived barriers to Cervical Cancer (CC) screening.

Aim 1: Examine general awareness and cultural factors (fatalism, religiosity/spirituality, temporal orientation, medical mistrust, and acculturation) related to cancer control and prevention among African Americans (AA) and Sub Saharan African (SAI) Immigrants.

Aim 2: Examine the socioecological barriers and facilitators to CC screening and self-sampling to inform tailoring of an evidenced based cervical health program to promote CC screening.

Aim 3: Assess feasibility, acceptability, and preliminary efficacy in a pilot test of the Health is Wealth: A Cervical Health Program among 30 AA and 30 SAI women using quasi-experimental design.

This study will take place in 2 phases.

Detailed description: In phase 1, the investigators will conduct a cross-sectional survey with 150 Black men and women to examine factors impacting cervical cancer screening. Also, as part of phase 1, Aim 2 employs focus groups and a quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. In phase 2, Aim 3 will assess feasibility, acceptability, and preliminary efficacy of the Health is Wealth: A Cervical Health Program intervention among 30 African American and 30 Sub-Saharan African immigrant women.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Black woman (African American or Sub-Saharan African Immigrant)
* No pap smear within the last three years or no pap smear/HPV co-test within past five years
* Able to speak and write in English
* Reside in Kentucky

Exclusion Criteria:

* Do not self-identify as Black woman (African American or Sub-Saharan African Immigrant)
* History of hysterectomy
* History of cervical cancer
* Being pregnant
* Unable to speak and write in English
* Do not reside in Kentucky

Primary outcomes:
measure: Completion of HPV self-sampling
timeFrame: Baseline
measure: Change in Cervical cancer Knowledge
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
measure: Change in HPV knowledge
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
measure: Change in Self-efficacy
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
measure: Change in perceived barriers to screening
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
Secondary outcomes:
measure: Change in benefits
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
measure: Change in susceptibility
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
measure: Change in seriousness
timeFrame: 6 months (Baseline, immediately post-test, 6 month follow up)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Adebola Adegboyega, PhD
role: PRINCIPAL_INVESTIGATOR
References: