Cervical Cancer Screening Program for Asian American Women

Overseen By Wenyue Lu

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Cervical cancer, Hysterectomy, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a self-sampling kit for HPV testing can increase cervical cancer screening rates among underserved Korean, Vietnamese, and Chinese women. Participants will receive community-based education and assistance with the screening process, with some also receiving a self-sampling kit to collect a cervical sample at home. Women who identify as Korean, Vietnamese, or Chinese and haven't undergone cervical cancer screening in the last three years may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance screening access and health outcomes for these communities.

Do I have to stop taking my current medications to join the trial?

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

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 HPV self-sampling kit is safe for cervical cancer screening?

Research shows that collecting one's own sample for HPV testing is generally safe and easy. Studies indicate that self-sampling encourages more participation in cervical cancer screening by overcoming common obstacles.

For example, the FDA approved HPV tests that allow individuals to collect their own vaginal samples. This approval confirms that self-sampling is both safe and effective. Additionally, research found that many people find self-sampling kits acceptable, especially those who might not get screened otherwise.

Overall, evidence supports that self-sampling kits for HPV testing are safe. They offer a convenient and comfortable option for cervical cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a culturally tailored approach to cervical cancer screening for Asian American women, potentially increasing screening uptake in this underserved group. Unlike the standard Pap smear or HPV testing at a clinic, the trial offers HPV self-sampling kits, allowing women to collect samples at home, which can be more convenient and less intimidating. Additionally, the community-based education and navigation support aims to address cultural and language barriers, making the screening process more accessible and comfortable. This trial could pave the way for more personalized and effective screening strategies, enhancing early detection and prevention efforts in the community.

What evidence suggests that this trial's treatments could be effective for increasing cervical cancer screening rates in Asian American women?

Studies have shown that allowing women to collect their own samples for HPV (human papillomavirus) testing at home greatly increases the number of women screened for cervical cancer. In this trial, one group of participants will receive an HPV Self-Sampling kit, which research indicates more than doubles participation in screenings. This method is both effective and affordable, especially for women who don't get screened regularly. By making participation easier, self-sampling helps identify potential problems earlier. Overall, self-sampling is a promising way to increase screening and improve early detection of cervical cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Carolyn Y Fang, PhD

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for Korean or Vietnamese American women aged 30-65 who are overdue for cervical cancer screening and have not had a recent cytology-based screen or HPV test. It's not open to those with previous cervical abnormalities, those who've had their cervix removed, anyone with compromised immunity like HIV, or if they can't consent.

Inclusion Criteria

I haven't had a cervical cancer screening in the recommended time frame.

Only women who are of Asian race and identify themselves as Korean or Vietnamese are eligible to participate.

I am between 30 and 65 years old.

Exclusion Criteria

Have a compromised immune system (e.g., known HIV)

I have been diagnosed with cervical cancer or a cervical abnormality before.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance. The experimental group also receives a self-sampling kit for HPV testing.

6 months

Educational sessions and navigation assistance provided

Follow-up

Participants are monitored for participation in screening and cost-effectiveness of the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Community-Based Education
• HPV Self-Sampling
• Navigation to Screening

Trial Overview The study tests whether adding a self-sampling kit for HPV testing to an educational program and navigation assistance increases cervical cancer screening rates in the target group compared to just education and assistance.

How Is the Trial Designed?

Group I: HPV Self-Sampling Experimental Treatment 3 Interventions

Previously tested evidence-based intervention (i.e. culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided). Participants will also receive a self-sampling kit.

Group II: Evidence-Based Intervention Active Control 2 Interventions

Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Published Research Related to This Trial

The SUCCESS trial is testing innovative approaches to increase cervical cancer screening among underserved minority women, including HPV self-sampling and patient navigation, with a total of 600 participants aged 30-65 who have not been screened in the last 3 years.

If effective, HPV self-sampling could significantly improve access to cervical cancer screening in these communities, addressing barriers related to health insurance, cost, and cultural norms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial. Carrasquillo, O., McCann, S., Amofah, A., et al.[2021]

Cervical cancer screening rates among Asian American women are among the lowest compared to other ethnic/racial groups, contributing to significant disparities in cervical cancer incidence and mortality.

Community-based interventions that address knowledge gaps, cultural beliefs, and access barriers, such as using lay health workers and providing tailored educational materials, have shown promise in significantly increasing screening rates among Asian American women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to Cervical Cancer Screening Among Asian American Women. Fang, CY., Ma, GX., Tan, Y.[2021]

The culturally customized educational program 'Esperanza y Vida' successfully recruited 159 participants across three different locations, aiming to increase cancer awareness and screening among US Latinas, who face higher rates of late-stage breast and cervical cancers.

The program demonstrated that educational and screening interventions can be tailored to fit the unique characteristics of different Latino populations, suggesting that similar outreach efforts could effectively enhance cancer screening practices in various regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-site implementation of health education programs for Latinas. Sudarsan, NR., Jandorf, L., Erwin, DO.[2021]

A study involving 52 young adults (ages 18-29) from Korean, Vietnamese, and Filipino backgrounds revealed that many participants were unaware of cervical cancer, HPV, and Pap tests, highlighting a significant knowledge gap.

Low cervical cancer screening rates among Korean and Vietnamese females were linked to moral beliefs and lack of awareness, indicating a need for culturally tailored educational materials to improve understanding and increase screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young Asian Americans' knowledge and perceptions of cervical cancer and the human papillomavirus. Gor, BJ., Chilton, JA., Camingue, PT., et al.[2022]

A community-based intervention combining cervical cancer education and patient navigation significantly increased screening rates among Chinese American women, with 70% of participants in the intervention group getting screened compared to only 11.1% in the control group over a 12-month period.

Factors such as older age and greater perceived severity of cervical cancer were associated with higher screening rates, while poorer English fluency and lack of health insurance were barriers to obtaining screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. Wang, X., Fang, C., Tan, Y., et al.[2022]

A culturally tailored intervention significantly increased HPV-related knowledge, social support, self-efficacy, and comfort with self-sampling tests among 156 low-income Asian American women, demonstrating its effectiveness in this population.

This study is the first to promote HPV self-sampling tests specifically among Asian American women, highlighting the importance of community-based approaches in addressing health disparities in cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. Ma, GX., Zhu, L., Zhai, S., et al.[2023]

A one-time interactive, multimedia education program significantly improved cervical cancer knowledge and attitudes among low-income Latina women who had not been screened in the past 2 years, compared to a control group.

Despite the positive changes in knowledge and attitudes, the intervention did not lead to a significant increase in actual cervical cancer screening behavior, as both groups had similar rates of obtaining or making appointments for pap tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Cervical Cancer Education Intervention for Latinas Delivered Through Interactive, Multimedia Kiosks. Valdez, A., Napoles, AM., Stewart, SL., et al.[2021]

A community intervention program aimed at increasing breast and cervical cancer screening among Korean American women led to a significant improvement in mammogram rates after 18 months, but did not significantly affect Pap smears, breast self-examinations, or clinical breast examinations.

The lack of significant changes in some screening practices was likely due to incomplete implementation of the program, highlighting the importance of effective execution in community health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim assessment of a community intervention to improve breast and cervical cancer screening among Korean American women. Wismer, BA., Moskowitz, JM., Min, K., et al.[2019]

A multicomponent intervention that included culturally relevant cancer education and navigation services significantly increased cervical cancer screening rates among Korean American women, with an odds ratio of 25.9 compared to a control group.

The study involved 705 women recruited from 22 churches, and 12 months after the intervention, data from 588 participants showed that the program effectively addressed access barriers to screening in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Fang, CY., Ma, GX., Handorf, EA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5900042/

Self-Sampling for Human Papillomavirus Testing It was concluded that HPV self-sampling significantly improves the participation of women in cervical cancer screening (65). A more recent meta-analysis of 16 ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839517

Cost-Effectiveness of HPV Self-Testing Options for Cervical ... This economic evaluation examines the cost-effectiveness of mailed human papillomavirus (HPV) self-sampling kits among members of a US ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524653/

Cost-effectiveness of human papillomavirus (HPV) self ... Our findings show that employing HPV self-collection was both affordable and effective in increasing cervical cancer screening uptake among underscreened, ...

4. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(23)00076-2/fulltext

Effect of HPV self-collection kits on cervical cancer ... Mailed HPV self-collected samples have the potential for even greater effects if the US Food and Drug Administration approve them for primary ...

5. mdanderson.org mdanderson.org/newsroom/mailed-self-collection-hpv-tests-boost-cervical-cancer-screening.h00-159777234.html

Mailed self-collection HPV tests boost cervical cancer ... Mail-in self-collection tests for human papillomavirus (HPV) more than doubled cervical cancer screening participation among never- and under-screened US women.

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2835169

Self-Collection for Cervical Cancer Screening in a Safety ... This randomized clinical trial compares the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone ...

7. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting

HPV Tests with Self-Collection in a Health Setting Approved The expanded approval of two HPV tests allows the patient to collect a vaginal sample themselves in a health care setting rather than during ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0749379723004415

Self-Sampling for Human Papillomavirus Testing This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a ...

9. journals.lww.com journals.lww.com/jlgtd/fulltext/2025/04000/self_collected_vaginal_specimens_for_hpv_testing_.6.aspx

Self-Collected Vaginal Specimens for HPV Testing:... Human papillomavirus testing of self-collected vaginal specimens expands cervical cancer screening options and has potential to increase access for currently ...