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Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2

A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082882
Acronym
SEMM2
Enrollment
8000
Registered
2023-10-13
Start date
2020-02-20
Completion date
2025-08-31
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cervical Cancer

Keywords

Cervical cancer screening, Breast cancer detection, HPV vaccination

Brief summary

The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.

Detailed description

This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). The investigators also describe the implementation of the program during a longer time period (2020-.2024).

Interventions

BEHAVIORALEducation

Education will be delivered in person in a group education setting or individually by phone. Group education will include a \ 1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).

Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.

Sponsors

Cancer Prevention Research Institute of Texas
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* Primarily residing in the Gulf Coast & Lower Rio Grande Valley county areas (or other counties in Texas) * Women 40 years of age and older with no mammogram in the past 2 years * Women 21-65 years, with no Pap test in the past 3 years * Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.

Exclusion criteria

* Current pregnancy * Have a current or prior cancer diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Number of women 40 and older who complete mammogram screeningBetween baseline and end of study (about 9 months)Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Number of women 21-65 years who complete Pap test screeningBetween baseline and end of study (about 9 months)Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
Number of women 18-26 years who initiate (complete first dose) of the HPV vaccineBetween baseline and end of study (about 9 months)Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.

Secondary

MeasureTime frameDescription
Number of women 18-26 years who receive dose 2 of HPV vaccinebetween baseline and end of study (about 9 months)Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.
Number of women 18-26 years who receive dose 3 of HPV vaccinebetween baseline and end of study (about 9 months)Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026