Promoting Cervical Cancer Screening Among African American and Sub Saharan African Immigrants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Number of Participants That Completed HPV Self-sampling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Phase 1 focus group
Quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention.
干预措施: Health is Wealth: A Cervical Health Program (Behavioral)
Black women cervical cancer screening
Participants in this group with receive the Health is Wealth intervention.
干预措施: Health is Wealth: A Cervical Health Program (Behavioral)
Phase 1 survey
Cross-sectional survey with Black men and women to examine factors impacting cervical cancer screening.
干预措施: Health is Wealth: A Cervical Health Program (Behavioral)
结局指标
主要结局
Number of Participants That Completed HPV Self-sampling
时间窗: Baseline
HPV self-sampling kit return
Change in Cervical Cancer Knowledge
时间窗: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Cervical cancer awareness will be assessed with Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 points), agree (scores 4 points) and strongly agree (scores 5 points). Awareness of warning signs and risk factors will be assessed with an 11 question prompted checklist. This instrument has been found to be valid and reliable in multiple populations. Scores range from 11-55. A higher score indicates greater cervical cancer knowledge.
Change in Human Papillomavirus (HPV) Knowledge
时间窗: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
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. A higher score indicates greater knowledge on HPV.
Change in Self-Efficacy in Completing Pap Test
时间窗: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Self-efficacy will be assessed with 10 items measured on a five-point Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 point)s, agree (scores 4 points) and strongly agree (scores 5 points). Score ranges from 10-50. A higher score indicates a greater perceived ability to complete steps for a pap test. This is a well validated and reliable instrument.
Change in Perceived Barriers to Screening
时间窗: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)
Barriers to screening will be assessed with 14 items measured on a five-point Likert style scale response choices: strongly disagree (scores 1 point), disagree (scores 2 points), neutral (scores 3 points), agree (scores 4 points) and strongly agree (scores 5 points). Scores range from 14-70. A higher score indicates a greater perceived barrier to screening.
次要结局
- Change in Perceived Benefits of Pap Test(6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up))
- Change in Perceived Susceptibility to Cervical Cancer(6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up))
- Change in Perceived Seriousness to Cervical Cancer(6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up))
- Change in Perceived Cervical Cancer Risk Factors(6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up))
研究者
Adebola Adegboyega
Assistant Professor
University of Kentucky