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Completed

NCT Number: NCT06082505

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

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.

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Key information

Conditions

Cervical Cancer Breast Cancer Breast Diseases Breast Neoplasms 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

21 year and older

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 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).

Who can participate

Healthy volunteers accepted: Yes

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

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

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 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).

Navigation to clinic

Behavioral

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.

Primary outcomes

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

    Time frame: Between 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.

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

    Time frame: Between 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.

  3. Number of women 21-26 years old who initiate their HPV vaccination series.

    Time frame: 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 outcomes

  1. Number of participants who received the second dose of HPV vaccine

    Time frame: between 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.

  2. Number of participants who received the third dose of HPV vaccine

    Time frame: between 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.

  3. Number of participants who received a clinical breast exam

    Time frame: between 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.

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: SEMM1

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2023
Registry last updated
Dec 1, 2023

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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