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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help Latinas get screened for breast and cervical cancer and receive the HPV vaccine through an online platform. The goal is to determine if the new online strategy, "Salud en Mis Manos - Dissemination and Implementation Assistance," is more effective than current methods, known as "Salud en Mis Manos- Usual Implementation Practice," in reaching and assisting more people. Latinas who have not had recent cancer screenings or haven't started the HPV vaccine and have at least one unmet need regarding cancer prevention might be a good fit for participation. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could enhance cancer prevention for Latinas.

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 this implementation strategy is safe for increasing cancer screening and HPV vaccination?

Research shows that Salud en Mis Manos (SEMM) is a community health program designed to assist with breast and cervical cancer screenings and HPV vaccinations. It builds on the success of another program, Cultivando La Salud. Specific information on side effects or safety issues for SEMM-DIA, the new support system under evaluation, is not yet available.

Since SEMM-DIA is an educational and support program, it does not carry the same risks as a new medication. The main goal is to assess how effectively the program facilitates cancer screenings and HPV vaccinations, which are established medical practices known to be safe. Therefore, SEMM-DIA is expected to be safe and beneficial, focusing on improving access and understanding rather than introducing new medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies for preventing cervical cancer through online cancer screening and HPV vaccination. This approach, called Salud en Mis Manos (SEMM), is unique because it emphasizes both dissemination and implementation assistance, offering a comprehensive, multi-faceted strategy that differs from the usual practice. Unlike standard methods that might focus solely on vaccination or screening separately, SEMM-DIA combines these elements, potentially increasing effectiveness and accessibility. By integrating technology and community engagement, this strategy aims to improve cervical cancer prevention efforts, making it a promising development in public health.

What evidence suggests that this trial's strategies could be effective for cervical cancer prevention?

Research shows that the Salud en Mis Manos (SEMM) program has successfully increased cancer screenings and HPV vaccinations among Latinas. Community health workers provide culturally relevant health education and guidance, and the program has met or exceeded its goals in expanding cancer prevention and screening services. In this trial, participants will join one of two arms: the SEMM-DIA strategy, which enhances the existing program with online support, or the SEMM-Usual Implementation Practice, which includes all current SEMM materials. Existing evidence supports SEMM-DIA's potential to effectively increase cancer screenings and vaccinations, suggesting it could further improve efforts to prevent cervical cancer. ^{1 4 5 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10069633/

A breast and cervical cancer screening and HPV ... Salud en Mis Manos (SEMM), adapted from Cultivando La Salud, is a community health worker- (CHW-) delivered evidence-based intervention (EBI), shown to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05524480

Accelerating the Implementation of a Breast and Cervical ... The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which ...

3. sph.uth.edu sph.uth.edu/research/centers/chppr/prc/

SEMM-DIA - UTHealth School of Public Health SEMM-DIA is an implementation support system for Salud en Mis Manos (SEMM), an evidence-based breast and cervical education and navigation program for Latinas.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06082882

Salud en Mis Manos - Breast and Cervical Cancer ... This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing ...

5. sph.uth.edu sph.uth.edu/news/story/salud-en-mis-manos-program-surpasses-goals-expands-cancer-prevention-and-screening-services-for-underserved-latinas-across-texas

Salud en Mis Manos Program Surpasses Goals, Expands ... Evaluation results of the evidence-based program indicate that the SEMM program met or exceeded its goals by delivering culturally tailored ...

6. careacross.com careacross.com/clinical-trials/trial/NCT05524480

Accelerating the Implementation of a Breast and Cervical ... Summary: The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) ...

7. ctv.veeva.com ctv.veeva.com/study/accelerating-the-implementation-of-a-breast-and-cervical-cancer-screening-and-hpv-vaccination-interv

Accelerating the Implementation of a Breast and Cervical ... The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance ...