Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1 (SEMM1)

The University of Texas System (UT)

Status: Completed

Conditions: Breast Cancer; Cervical Cancer

Treatments: Behavioral: Education; Behavioral: Navigation to clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT06082505

HSC-SPH-16-0159

PP160047 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8,262 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8,262 participants in 2 patient groups

In-Person Delivered Breast and Cervical Cancer Behavioral Intervention

Experimental group

Description:

Community health worker deliver behavioral education and referrals to low-cost services. Deliver 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: Navigation to clinic

Behavioral: Education

Telephone Delivered Breast and Cervical Cancer Behavioral Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Navigation to clinic

Behavioral: Education