"Health is Wealth" Program for Cervical Cancer Prevention

Overseen By Adebola Adegboyega, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AdegboyegaA

Disqualifiers: Non-black, Hysterectomy, Cervical cancer, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to promote cervical cancer screening among Black women, specifically African American and Sub-Saharan African immigrants, by reducing barriers and increasing awareness. The "Health is Wealth: A Cervical Health Program" will examine cultural factors such as medical mistrust and religion that may affect screening. It will also evaluate the program's ease and effectiveness in encouraging women to get screened. Women who haven't had a pap smear in the last three years or a combined pap/HPV test in the last five years, and who live in Kentucky, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving cervical health in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Health is Wealth program is safe for cervical cancer prevention?

Research shows that the "Health is Wealth" Cervical Health Program encourages cervical cancer screening and improves access. This program involves no drugs or medical procedures, ensuring safety. Instead, it emphasizes education and awareness.

No reports of negative effects have emerged, as the program requires no medication or physical treatments. It centers on learning and understanding cervical health. Such programs are usually well-received because they aim to support and inform rather than provide medical treatment.

This study is in its early stages, often called a pilot, to assess its effectiveness and participant usefulness. With its focus on education, safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Health is Wealth" cervical health program because it focuses on enhancing cervical cancer screening specifically for Black women, addressing disparities in healthcare access and outcomes. Unlike standard treatments, which often involve medical procedures like Pap smears or HPV vaccines without tailored community engagement, this program emphasizes culturally sensitive education and support. By potentially increasing screening rates and early detection among a demographic that faces higher cervical cancer mortality rates, this program aims to save lives through prevention and awareness.

What evidence suggests that the Health is Wealth program is effective for cervical cancer prevention?

Research shows that cervical cancer screening is effective when conducted properly. The Health is Wealth program, provided to participants in this trial, encourages more women to undergo screening and simplifies the process. Studies have found that screening rates are low, particularly among women with lower incomes. This program seeks to address this by increasing screening among African American women and women from Sub-Saharan Africa. By improving access to screenings and reducing fears or mistrust, the program aims to detect cervical cancer early and enhance prevention. ^{1 2 6 7 8}

Who Is on the Research Team?

Adebola Adegboyega, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for Black women, either African American or Sub-Saharan African Immigrant, living in Kentucky who haven't had a pap smear in the last three years or a pap/HPV co-test in five. Participants must speak and write English but can't join if they've had a hysterectomy, cervical cancer history, are pregnant, or don't meet the residency and identity criteria.

Inclusion Criteria

Able to speak and write in English

I haven't had a pap smear in the last 3 years or a pap smear/HPV test in 5 years.

Self-identify as Black woman (African American or Sub-Saharan African Immigrant)

Exclusion Criteria

Being pregnant

Do not self-identify as Black woman (African American or Sub-Saharan African Immigrant)

I have had a hysterectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Survey and Focus Groups

Conduct a cross-sectional survey with 150 Black men and women to examine factors impacting cervical cancer screening and employ focus groups with 30 participants to guide development of a tailored intervention.

8 weeks

Phase 2: Intervention Pilot Test

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.

6 months

Baseline, immediately post-test, 6 month follow-up

Follow-up

Participants are monitored for changes in cervical cancer knowledge, HPV knowledge, self-efficacy, perceived barriers, benefits, susceptibility, and seriousness.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health is Wealth: A Cervical Health Program

Trial Overview

The study tests 'Health is Wealth: A Cervical Health Program' aimed at increasing cervical cancer screening rates. It explores cultural attitudes towards health and identifies barriers to screening. The program's feasibility and effectiveness will be pilot tested on 60 women using a quasi-experimental design over two phases.

How Is the Trial Designed?

Group I: Black women cervical cancer screening Experimental Treatment 1 Intervention

Participants in this group with receive the Health is Wealth intervention.

Who Is Running the Clinical Trial?

AdegboyegaA

Lead Sponsor

Trials

1

Recruited

60+

Adebola Adegboyega

Lead Sponsor

Trials

1

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 603 women aged 25 to 59 in Boa Vista, Brazil, the cervical cancer screening program showed a high adherence rate of 85.7% over the past three years, indicating effective coverage in a high-incidence area.

Factors such as higher household income and recent medical consultations were linked to lower rates of non-adherence, while a lack of knowledge about the disease and its prevention contributed to missed screenings, highlighting the need for better education and outreach for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer screening coverage in a high-incidence region. Navarro, C., Fonseca, AJ., Sibajev, A., et al.[2019]

The single-visit cervical carcinoma prevention program successfully provided screening, diagnosis, and treatment to underserved women, with 90 out of 98 participants being Spanish speakers and many lacking regular healthcare access.

Participants showed significant improvement in their knowledge about cervical carcinoma prevention, and all reported high satisfaction with the program, indicating its effectiveness in both education and care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-visit cervical carcinoma prevention program offered at an inner city church: A pilot project. Holschneider, CH., Felix, JC., Satmary, W., et al.[2006]

Cervical cancer screening through the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) currently saves 1,731 life years (LYs) and gains 1,608 quality-adjusted life years (QALYs) per 100,000 women screened, highlighting its effectiveness in improving health outcomes for low-income women.

Increasing the screening rate from 6.5% to between 10-25% of eligible women could potentially save an additional 6,626 to 34,896 LYs and gain 6,153 to 32,407 QALYs, demonstrating significant health benefits from broader access to screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the impact of increasing cervical cancer screening in the National Breast and Cervical Cancer Early Detection Program among low-income women in the USA. Pollack, LM., Ekwueme, DU., Hung, MC., et al.[2023]

A community-based model for cervical cancer prevention was successfully implemented, involving 8,382 women aged 35 to 59 from 130 rural communities, allowing local leaders to manage screening effectively.

The model achieved an impressive average callback rate of 84.3% for follow-up, indicating strong community engagement, and suggests that training local doctors could further enhance management of positive cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and evaluation of a community based model for cervical cancer screening based on self-sampling. Belinson, JL., Wang, G., Qu, X., et al.[2022]

Latina women with low socioeconomic status face higher risks of cervical cancer due to lower screening rates, which are linked to increased mortality in this group.

Community health workers, or promotoras de salud, using the AMIGAS education curriculum can effectively enhance access to cervical cancer screening and education, potentially saving lives by increasing awareness and utilization of Pap tests and HPV vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Culturally Sensitive Approach to Cervical Cancer Prevention in the Latina Population Using the Promotora Model. Cheun, ASA., Loomis, J.[2021]

Only 21% of countries worldwide provide all 9 interventions in the Essential Cancer Package for cervical cancer, with higher availability in Europe (45.3%) and high-income countries (54.3%).

Similarly, only 19.1% of countries offer all 5 interventions in the Primary Care Package, again showing better coverage in Europe (39.6%) and high-income countries (45.5%), highlighting a significant gap in cervical cancer prevention services globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce the impact of cervical cancer worldwide: Gaps and priority areas identified through the essential cancer and primary care packages: An analysis of effective interventions. Gatti, A., Haruyama, R., Elit, L., et al.[2021]

The study highlights significant gaps in the prevention of cervical and breast cancer in Buenos Aires, where health services often focus on isolated aspects of prevention rather than a comprehensive approach, limiting their effectiveness.

Interviews with various health service providers revealed that the fragmented healthcare system leads to social inequalities in access to preventive measures, resulting in inadequate education and awareness among women about cancer risks and treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of cervical and breast cancer in health services and non-governmental organizations in the city of Buenos Aires]. Ponce, M.[2019]

The cervical cancer prevention program significantly increased knowledge about cervical cancer among married women immigrants, with a notable difference in knowledge scores between the intervention group and the control group (F=12.55, p<0.001).

Participants in the intervention group also showed a significant improvement in cancer prevention behaviors after attending the program, indicating its effectiveness in promoting proactive health measures (t=2.646, p=0.010).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an educational program to prevent cervical cancer among immigrants in Korea. Choi, SY.[2019]

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