Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2 (SEMM2)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Breast Cancer; Cervical Cancer

Treatments: Behavioral: Navigation to clinic; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06082882

PP190061 (Other Grant/Funding Number)

HSC-SPH-19-0775

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8,000 estimated patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8,000 participants in 3 patient groups

In-Person Delivered Breast and Cervical Cancer Behavioral Intervention

Experimental group

Description:

Community health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Treatment:

Behavioral: Education

Behavioral: Navigation to clinic

Telephone Delivered Breast and Cervical Cancer Behavioral Intervention

Experimental group

Description:

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Treatment:

Behavioral: Education

Behavioral: Navigation to clinic

Zoom Delivered Breast and Cervical Cancer Behavioral Intervention

Experimental group

Description:

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Treatment:

Behavioral: Education

Behavioral: Navigation to clinic