Online Cancer Screening & HPV Vaccination Strategy for Cervical Cancer Prevention

Overseen By Lara Savas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Prior cancer diagnosis

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

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and HPV vaccination program for Latinas (SEMM).

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 Salud en Mis Manos for cervical cancer prevention?

Research shows that Salud en Mis Manos, a community health worker-delivered program, has been effective in increasing breast and cervical cancer screening among low-income Latinas. Additionally, educational interventions have been successful in increasing HPV vaccine uptake and cervical cancer prevention knowledge, which are key components of the Salud en Mis Manos strategy. ^{1 2 3 4 5}

Is the HPV vaccination and screening strategy safe for humans?

The HPV vaccination is generally considered safe, but there are concerns about serious adverse events that may be underreported. It is important to continue monitoring and evaluating the safety of these vaccines. ^{4 6 7 8 9}

How does the treatment 'Salud en Mis Manos' for cervical cancer prevention differ from other treatments?

The 'Salud en Mis Manos' treatment is unique because it combines online cancer screening and HPV vaccination strategies to prevent cervical cancer, focusing on increasing access and education, particularly in underserved regions. This approach is novel as it integrates technology and community-based interventions to overcome barriers like geographical and cultural challenges, which are not typically addressed by standard treatments. ^{1 10 11 12 13}

Research Team

Lara Savas, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Maria E Fernandez, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for Latinas aged 21-65 who haven't had a Pap test in the last 3 years, those aged 50-75 without a mammogram in the past 2 years, and those aged 21-26 who haven't started HPV vaccination. Participants must intend to use SEMM and be served by clinics with LHWs that cater to Latina populations in Texas.

Inclusion Criteria

Latinas who self-identify as Hispanic/Latina

Latinas who have at least one unmet breast or cervical cancer prevention need, following Electronic Clinical Quality Measures

Organization inclusion criteria: Clinic or community health center (CHC) with LHWs serving Latina populations

Exclusion Criteria

Organization exclusion criteria: Clinics/Community Health Centers not located in Texas

I am a Latina with a cancer diagnosis, affected by changes in cancer screening guidelines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the SEMM-DIA program to increase the reach, effectiveness, and implementation of breast and cervical cancer screening and HPV vaccination

8 months

Follow-up

Participants are monitored for the reach, effectiveness, and implementation of the SEMM-DIA program

8 months

Treatment Details

Interventions

• Salud en Mis Manos - Dissemination and Implementation Assistance
• Salud en Mis Manos- Usual Implementation Practice

Trial Overview The study is testing 'Salud en Mis Manos' (SEMM), an internet platform designed to improve breast/cervical cancer screening and HPV vaccination among Latinas. It compares usual implementation practices against SEMM with extra support strategies.

Participant Groups

Group I: Salud en Mis Manos - Dissemination and Implementation Assistance Experimental Treatment 1 Intervention

The multi-component and multi-faceted implementation strategy SEMM-DIA

Group II: Salud en Mis Manos - Usual Implementation Practice Active Control 1 Intervention

The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

References

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

A Pan American Health Organization strategy for cervical cancer prevention and control in Latin America and the Caribbean. [2008]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Using Implementation Mapping to increase uptake and use of Salud en Mis Manos: A breast and cervical cancer screening and HPV vaccination intervention for Latinas. [2023]

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

Results of a Health Education Message Intervention on HPV Knowledge and Receipt of Follow-up Care among Latinas Infected with High-risk Human Papillomavirus. [2021]

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

Increasing Cervical Cancer and Human Papillomavirus Prevention Knowledge and HPV Vaccine Uptake through Mother/Daughter Education. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Increasing cervical cancer screening for a multiethnic population of women in South Texas. [2021]

6. England pubmed.ncbi.nlm.nih.gov

High risk HPV infection prevalence and associated cofactors: a population-based study in female ISSSTE beneficiaries attending the HPV screening and early detection of cervical cancer program. [2020]

7. Chile pubmed.ncbi.nlm.nih.gov

[Cancer of cervix in Chile. Too much vaccine amid a neglected Papanicolau]. [2014]

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

Progress toward implementation of human papillomavirus vaccination--the Americas, 2006-2010. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of HPV Tests in Latin America: What We Learned; What Should We Have Learned, and What Can We Do Better? [2022]

10. England pubmed.ncbi.nlm.nih.gov

Control of cervical cancer in Peru: Current barriers and challenges for the future. [2020]

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

Cervical cancer screening programs in Latin America and the Caribbean. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Recommendations for cervical cancer prevention in Latin America and the Caribbean. [2008]

13. Switzerland pubmed.ncbi.nlm.nih.gov

HPV vaccination in Latin America: Coverage status, implementation challenges and strategies to overcome it. [2022]