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OpenTrials
Completed

NCT Number: NCT04927494

Cervical Cancer Prevention for Black Adults

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health is Wealth: A Cervical Health Program

Behavioral

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.

Primary outcomes

  1. Number of Participants That Completed HPV Self-sampling

    Time frame: Baseline

    HPV self-sampling kit return

  2. Change in Cervical Cancer Knowledge

    Time frame: 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.

  3. Change in Human Papillomavirus (HPV) Knowledge

    Time frame: 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.

  4. Change in Self-Efficacy in Completing Pap Test

    Time frame: 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.

  5. Change in Perceived Barriers to Screening

    Time frame: 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.

Secondary outcomes

  1. Change in Perceived Benefits of Pap Test

    Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

    Perceived benefits of getting a pap test will be assessed with 4 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 4-20. A higher scores indicates greater perceived benefits of getting a pap test.

  2. Change in Perceived Susceptibility to Cervical Cancer

    Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

    Perceived susceptibility will be assessed with 4 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). Score ranges from 4-20. A higher scores indicates greater perceived susceptibility to cervical cancer.

  3. Change in Perceived Seriousness to Cervical Cancer

    Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

    Perceived seriousness will be assessed with 7 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 7-35. A higher score indicates a greater perceived seriousness of cervical cancer.

  4. Change in Perceived Cervical Cancer Risk Factors

    Time frame: 6 months (Baseline, immediately post-test (up to 1 week), 6 month follow up)

    Perceived cervical cancer risk will be assessed with 11 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 11-55. A higher scores indicates a greater knowledge of cervical cancer risk factors.

Sponsors and collaborators

Lead sponsor

Adebola Adegboyega

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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