Clinical trial NCT06082505: Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Breast Cancer
Keywords: Cervical cancer prevention
Breast cancer detection
HPV vaccination
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2023-10-13
Enrollment: 8262
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of women 40 years and older who complete mammogram screening
timeFrame: Between baseline and end of study (about 9 months)
measure: Number of women 21-65 years old who complete Pap test screening
timeFrame: Between baseline and end of study (about 9 months)
measure: Number of women 21-26 years old who initiate their HPV vaccination series.
timeFrame: between baseline and end of study (about 9 months)
Secondary outcomes:
measure: Number of participants who received the second dose of HPV vaccine
timeFrame: between baseline and end of study (about 9 months)
measure: Number of participants who received the third dose of HPV vaccine
timeFrame: between baseline and end of study (about 9 months)
measure: Number of participants who received a clinical breast exam
timeFrame: between baseline and end of study (about 9 months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lara Savas, PhD
role: PRINCIPAL_INVESTIGATOR
References: