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

SS
Overseen BySurendranath S. Shastri
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing HPV (human papillomavirus) self-collection kits, along with education and support, can improve cervical cancer screening rates among Hispanic and African American women in Houston, Texas. Participants will complete questionnaires, attend a health education session, and use the self-collection kit at home. The trial seeks Hispanic or African American women who live at least half the time in the participating housing developments, have a working phone, and can read and speak English or Spanish. As an unphased trial, it offers participants the chance to contribute to important research that may enhance the accessibility and effectiveness of cervical cancer screening.

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 HPV self-collection is safe for cervical cancer screening?

A previous study found that people can safely and accurately collect their own samples for HPV (human papillomavirus) testing, which screens for cervical cancer. This method allows individuals to take samples themselves, potentially increasing screening rates. Research has shown that this self-collection method is well-accepted and now approved for use in healthcare settings, making it a reliable choice for many.

Additionally, Project Self, which uses HPV self-collection kits along with education and support, safely increased cervical cancer screening rates. These kits are mailed to participants, providing a safe and easy way for those who might not visit a clinic to get tested.

Overall, evidence suggests that both self-collection for HPV testing and Project Self are safe and effective ways to increase cervical cancer screening.12345

Why are researchers excited about this trial?

Researchers are excited about Project Self because it offers a new approach to cervical cancer prevention by empowering women to take charge of their own health. Unlike traditional methods requiring a visit to a healthcare provider for a Pap smear or HPV test, this method allows women to self-collect samples at home using an HPV self-collection kit. Additionally, the inclusion of a health education session helps participants better understand cervical cancer risks and prevention, which is crucial for underserved communities. This approach not only increases accessibility and convenience but also aims to improve screening rates among Hispanic and African American women, who often face barriers to traditional screening methods.

What evidence suggests that Project Self could improve cervical cancer screening rates?

Research shows that HPV self-collection kits, which participants in this trial will receive, can significantly increase cervical cancer screening rates. These kits are affordable and help reach women who might not otherwise get screened. Studies have found that mailing these self-collection tests more than doubles the number of under-screened women in the U.S. who participate in cervical cancer screening. The samples women collect themselves are reliable, with a high accuracy rate of about 94.6% for detecting HPV. This method simplifies screening by allowing women to collect samples independently, removing many common obstacles to testing.56789

Who Is on the Research Team?

SS

Surendranath S Shastri

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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
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Exclusion Criteria

Self-reported as pregnant
Another household member is enrolled in this protocol.
I have had a hysterectomy.
See 1 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Screening (questionnaire, health education, self-collection)Experimental Treatment3 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]
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.
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]
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.
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]

Citations

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 ...
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, ...
Effect of HPV self-collection kits on cervical cancer ...Mailed HPV self-collection testing has potential to increase uptake of cervical cancer screening among under-screened women. Mailed at-home HPV ...
Self-Collected Vaginal Specimens for HPV Testing:...DISCUSSION. Use of self-collected vaginal specimens for primary HPV screening is an effective approach to expand access to cervical cancer screening.
Self-Sampling for Human Papillomavirus TestingSelf-sampling may result in more individuals willing to participate in cervical cancer screening, because it removes many of the barriers that prevent women
Self-Collected Vaginal Specimens for HPV TestingClinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk ...
Self-collection for HPV Testing to Improve Cervical Cancer ...This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or ...
HPV Tests with Self-Collection in a Health Setting ApprovedThe expanded approval of two HPV tests allows the patient to collect a vaginal sample themselves in a health care setting rather than during ...
Clinical Validation of a Vaginal Cervical Cancer Screening ...This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...
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