Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
- Conditions
- Breast CancerCervical Cancer
- Interventions
- Behavioral: EducationBehavioral: Navigation to clinic
- Registration Number
- NCT06082882
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 8000
- 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.
- Current pregnancy
- Have a current or prior cancer diagnosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description In-Person Delivered Breast and Cervical Cancer Behavioral Intervention Education 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. In-Person Delivered Breast and Cervical Cancer Behavioral Intervention Navigation to clinic 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. Telephone Delivered Breast and Cervical Cancer Behavioral Intervention Education 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. Telephone Delivered Breast and Cervical Cancer Behavioral Intervention Navigation to clinic 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. Zoom Delivered Breast and Cervical Cancer Behavioral Intervention Education 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. Zoom Delivered Breast and Cervical Cancer Behavioral Intervention Navigation to clinic 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.
- Primary Outcome Measures
Name Time Method Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine Between baseline and end of study (about 9 months) Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.
Number of women 40 and older who complete mammogram screening Between baseline and end of study (about 9 months) Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys
Number of women 21-65 years who complete Pap test screening Between baseline and end of study (about 9 months) Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.
- Secondary Outcome Measures
Name Time Method Number of women 18-26 years who receive dose 3 of HPV vaccine between baseline and end of study (about 9 months) Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
Number of women 18-26 years who receive dose 2 of HPV vaccine between baseline and end of study (about 9 months) Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States