Clinical trial NCT06082882: Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
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: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Keywords: Cervical cancer screening
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: 8000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of women 40 and older who complete mammogram screening
timeFrame: Between baseline and end of study (about 9 months)
measure: Number of women 21-65 years who complete Pap test screening
timeFrame: Between baseline and end of study (about 9 months)
measure: Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine
timeFrame: Between baseline and end of study (about 9 months)
Secondary outcomes:
measure: Number of women 18-26 years who receive dose 2 of HPV vaccine
timeFrame: between baseline and end of study (about 9 months)
measure: Number of women 18-26 years who receive dose 3 of HPV vaccine
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: