"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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Health is Wealth: A Cervical Health Program treatment?

The effectiveness of cervical cancer prevention programs is supported by research showing that increasing access to screening and education, especially in underserved populations, can save lives and improve health outcomes. Programs like the National Breast and Cervical Cancer Early Detection Program and community health worker models have been effective in increasing screening rates and awareness, which are key components of cervical cancer prevention. ^{1 2 3 4 5}

How does the 'Health is Wealth' treatment for cervical cancer prevention differ from other treatments?

The 'Health is Wealth' program is unique because it focuses on community-based cervical cancer prevention, allowing communities to manage screening while healthcare systems concentrate on evaluating and managing positive cases. This approach differs from traditional methods by integrating screening, diagnosis, treatment, and education in familiar community settings, such as churches, making it more accessible and potentially increasing adherence. ^{1 2 6 7 8}

Research Team

Adebola Adegboyega, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The development and evaluation of a community based model for cervical cancer screening based on self-sampling. [2022]

2. Netherlands 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Culturally Sensitive Approach to Cervical Cancer Prevention in the Latina Population Using the Promotora Model. [2021]

4. Argentina pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A single-visit cervical carcinoma prevention program offered at an inner city church: A pilot project. [2006]

7. Brazil pubmed.ncbi.nlm.nih.gov

Cervical cancer screening coverage in a high-incidence region. [2019]

8. Thailand pubmed.ncbi.nlm.nih.gov

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