HPV Self-Testing for Cervical Cancer
(PRESTIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to make cervical cancer screening easier and more accessible by evaluating whether mailing HPV self-testing kits can boost participation among underserved minority women. It compares different methods: receiving a phone call, receiving the kit by mail, and receiving both the kit and a follow-up call for guidance. Women who haven't had a Pap test in over 3.5 years and are patients of Harris Health System in Houston, Texas, may be eligible. This trial could be ideal for those who find it difficult to attend in-person screenings regularly. As an unphased trial, this study offers a unique opportunity to contribute to innovative screening methods that could improve accessibility for many.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on cervical cancer screening, so it's best to ask the trial coordinators for more details.
What prior data suggests that the HPV self-sampling kit is safe for cervical cancer screening?
Research shows that mailed HPV self-sampling kits are generally safe for cervical cancer screening. Many women find it easy and acceptable to collect their own samples at home. This method has been tested with various groups, including women who might not regularly visit clinics for screening.
Studies have not reported any major safety issues or serious side effects. Most participants use the kits without problems, and the self-sampling process has no significant negative effects.
Adding patient navigation, where someone guides participants through the process, is also safe. This extra support introduces no new risks. Overall, the self-sampling approach is well-received and increases participation in screening without compromising safety.12345Why are researchers excited about this trial?
Researchers are excited about the HPV self-testing trial because it could revolutionize how cervical cancer screenings are conducted. Unlike traditional Pap smears that require a visit to the doctor, this method allows individuals to collect samples themselves at home with a mailed HPV self-sampling kit. This approach not only offers convenience and privacy but could also increase screening rates by reaching those who face barriers to accessing healthcare facilities. Additionally, the trial explores the benefit of patient navigation, where trained navigators provide personalized follow-up and education, potentially boosting participation and understanding of the testing process.
What evidence suggests that this trial's treatments could be effective for increasing cervical cancer screening participation?
Research has shown that mailing HPV self-sampling kits can greatly increase cervical cancer screening rates among women. In this trial, one group of participants will receive a mailed HPV self-sampling kit. Studies have found these kits to be cost-effective and beneficial for women overdue for their tests. Another group in this trial will receive both the mailed kit and patient navigation, which provides assistance in understanding the process. This combined approach has proven especially useful in health centers serving underserved communities. Overall, evidence suggests these methods can improve access to screening and encourage more women to participate.26789
Who Is on the Research Team?
Jane Montealegre
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for women who are patients at Harris Health System in Houston, Texas. They should have had at least two visits there in the past five years, no cervical cancer or hysterectomy history, and not had a Pap test in 3.5 years or a Pap/HPV co-test in 5.5 years. Participants must be enrolled in an accepted healthcare plan and not currently pregnant, without recent cervical dysplasia, and able to communicate in English or Spanish.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive one of three outreach interventions: telephone recall, telephone recall with mailed self-sample HPV testing kits, or telephone recall with mailed self-sample HPV testing kits and patient navigation
Follow-up
Participants are monitored for clinical follow-up and treatment of cervical precancer if necessary
What Are the Treatments Tested in This Trial?
Interventions
- Mailed HPV Self-Sampling Kit
- Patient Navigation
- Telephone Recall
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator