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Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1

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
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082505
Acronym
SEMM1
Enrollment
8262
Registered
2023-10-13
Start date
2016-11-01
Completion date
2019-05-29
Last updated
2023-12-01

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 prevention, Breast cancer detection, HPV vaccination

Brief summary

The purpose is to evaluate implementation of a community-based prevention project aimed at increasing 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 Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).

Interventions

BEHAVIORALEducation

Education will be delivered in person in a group education setting or individually by phone. Group education will include 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).

Continue telephone based navigation tailored to participants' barriers using the 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
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Self identifies as Hispanic or Latina * Lives in Texas * Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older * Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older * HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series * Age limit for breast cancer screening group: 40 years and older * Age limit for cervical cancer screening group (Pap test): 21 years and older * Age limit for HPV vaccination group: 21-26 years

Exclusion criteria

* Current pregnancy * Current or prior cancer diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Number of women 40 years and older who complete mammogram screeningBetween baseline and end of study (about 9 months)Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-65 years old who complete Pap test screeningBetween baseline and end of study (about 9 months)Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
Number of women 21-26 years old who initiate their HPV vaccination series.between baseline and end of study (about 9 months)Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.

Secondary

MeasureTime frameDescription
Number of participants who received the second dose of HPV vaccinebetween baseline and end of study (about 9 months)Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Number of participants who received the third dose of HPV vaccinebetween baseline and end of study (about 9 months)Among women that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Number of participants who received a clinical breast exambetween baseline and end of study (about 9 months)Among women that have not had a mammogram in the past two years, 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