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NCT Number: NCT06082882

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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).

Navigation to clinic

Behavioral

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.

Primary outcomes

  1. Number of women 40 and older who complete mammogram screening

    Time frame: Between 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

  2. Number of women 21-65 years who complete Pap test screening

    Time frame: Between 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.

  3. Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine

    Time frame: Between 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 outcomes

  1. Number of women 18-26 years who receive dose 2 of HPV vaccine

    Time frame: between 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.

  2. Number of women 18-26 years who receive dose 3 of HPV vaccine

    Time frame: between 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Cancer Prevention Research Institute of Texas

Registry information

Official study title

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.

Acronym: SEMM2

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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