Cervical Cancer Prevention for Black Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Health is Wealth: A Cervical Health Program


Participation Criteria
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Eligibility Criteria
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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

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: Black women cervical cancer screening<br>Participants in this group with receive the Health is Wealth intervention. | Behavioral: Health is Wealth: A Cervical Health Program<br>* Health is Wealth: A Cervical Health Program will be introduced in a one-time 2-hour educational session, participants will be given HPV self-sampling kits, and instructional sheet that visually depicts the steps for self-sampling. The program will be culturally tailored to increase self-efficacy and knowledge while simultaneously addressing perceived health beliefs associated with cervical cancer and barriers associated with cervical cancer screening and HPV self-sampling. Content will be delivered in a group format (about 10-15 participants) by lecture, demonstration, and interactive exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of HPV self-sampling | HPV self-sampling kit return | Baseline | 
| Change in Cervical cancer Knowledge | Cervical cancer awareness will be assessed with Likert style questions (strongly disagree-1 to strongly agree-5) from the cervical cancer awareness toolkit. Awareness of warning signs and risk factors will be assessed with a prompted checklist. This instrument has been found to be valid and reliable in multiple populations. | 6 months (Baseline, immediately post-test, 6 month follow up) | 
| Change in HPV knowledge | Participants will complete 16 items assessing knowledge of HPV, 6 items about HPV testing, and 7 items about the vaccination. Response options included True, False, and Don't know, with scoring allocating one point for each correct response, and zero points for incorrect or Don't know responses, summed across items, for a potential range of 0-29. This instrument has been found to be valid and reliable in multiple populations. | 6 months (Baseline, immediately post-test, 6 month follow up) | 
| Change in Self-efficacy | Self-efficacy will be assessed with 10 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct. This is a well validated and reliable instrument. | 6 months (Baseline, immediately post-test, 6 month follow up) | 
| Change in perceived barriers to screening | Barriers will be assessed with 14 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct | 6 months (Baseline, immediately post-test, 6 month follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in benefits | Benefits will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct | 6 months (Baseline, immediately post-test, 6 month follow up) | 
| Change in susceptibility | Susceptibility will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct | 6 months (Baseline, immediately post-test, 6 month follow up) | 
| Change in seriousness | Seriousness will be assessed with 7 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct. | 6 months (Baseline, immediately post-test, 6 month follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer screening, HPV self-sampling, African American, Sub-Saharan African immigrants