Project Self Education & Screening Kit for Cervical Cancer Prevention in Hispanic and African American Women

Overseen By Surendranath S. Shastri

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hysterectomy, Cancer, Pregnant, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.

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 treatment HPV Self-Collection, HPV Self-Testing, Self-Collected HPV Sampling, At-Home HPV Testing, Project Self for cervical cancer prevention?

Research shows that HPV self-sampling can help overcome barriers to cervical cancer screening, such as limited awareness and access to healthcare, especially among minority women. A study found that a majority of women felt confident in performing self-sampling, indicating its potential to increase screening rates in underserved populations. ^{1 2 3 4 5}

Is HPV self-sampling safe for humans?

HPV self-sampling, which involves collecting a sample at home to test for the virus that can cause cervical cancer, has been found to be culturally acceptable and feasible in studies, suggesting it is safe for use in humans. ^{2 4 6 7 8}

How does the Project Self treatment for cervical cancer prevention differ from other treatments?

Project Self is unique because it focuses on self-education and self-sampling for cervical cancer screening, particularly targeting Hispanic and African American women who are often underscreened. This approach empowers women to collect samples at home, potentially increasing screening rates among underserved populations. ^{2 3 9 10 11}

Research Team

Surendranath S Shastri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for Hispanic and African American women living in Houston, Texas who identify as such, have a valid home address in certain housing developments, a working phone number, and can speak and read English or Spanish. Women with household members already enrolled, those who've had a hysterectomy, have had cancer or are pregnant cannot participate.

Inclusion Criteria

I have a working phone.

I am an African American or Hispanic woman.

Valid home address reflective of residence in the participating housing development(s) at least 50% of the time

Exclusion Criteria

Self-reported as pregnant

Another household member is enrolled in this protocol.

I have had a hysterectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Self-Collection

Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in cervical screening knowledge, attitudes, and practices, and HPV self-collection uptake

1 month

1 visit (in-person or virtual)

Treatment Details

Interventions

• HPV Self-Collection
• Project Self

Trial Overview Project Self aims to boost cervical cancer screening rates among the target demographic by providing HPV self-collection kits along with educational materials, counseling services, and guidance through the process.

Participant Groups

Group I: Screening (questionnaire, health education, self-collection) Experimental Treatment 3 Interventions

Participants complete questionnaires, take part in a health education session, and receive HPV self-collection kit.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

At-home self-collection for hrHPV testing, facilitated by community lay navigators, was found to be culturally acceptable and feasible for underscreened women in Appalachian Virginia, indicating a promising approach to improve cervical cancer screening rates.

In this pilot study, 59 self-collection kits were returned, with a 16.6% rate of high-risk HPV detected, highlighting the potential of this method to reach women who lack regular healthcare access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. Mitchell, EM., Lothamer, H., Garcia, C., et al.[2022]

An educational intervention significantly improved women's knowledge about HPV and cervical cancer among 302 participants, indicating that tailored information can enhance understanding of health issues.

Despite the increase in knowledge, the intervention did not significantly affect women's confidence or acceptability of the Self-HPV method, suggesting that further research is needed to explore long-term impacts on screening behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon. Sossauer, G., Zbinden, M., Tebeu, PM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Cervical Cancer Education Intervention for Latinas Delivered Through Interactive, Multimedia Kiosks. [2021]

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

Exploring factors associated with preferences for human papillomavirus (HPV) self-sampling among racially- and ethnically-diverse women in Minnesota: A cross-sectional study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Increasing Cervical Cancer Screening Among US Hispanics/Latinas: A Qualitative Systematic Review. [2021]

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

Cervical cancer prevention: new tools and old barriers. [2022]

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

Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. [2022]

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

Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Parental acceptance and uptake of the HPV vaccine among African-Americans and Latinos in the United States: A literature review. [2022]

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

Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial. [2020]

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

Impact of an educational intervention on women's knowledge and acceptability of human papillomavirus self-sampling: a randomized controlled trial in Cameroon. [2021]

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

Prevalence of High-Risk Human Papillomavirus by RNA Assay in Home Self-Collected Samples Among Underscreened People in North Carolina. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized trial of mailed HPV self-sampling for cervical cancer screening among ethnic minority women in South Florida. [2023]