SEMM1: Salud en Mis Manos - Expansion 1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is an evaluation of the Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion program. We evaluate the effect of the program on increasing breast and cervical cancer screening and HPV vaccination, using a one-group pre-post study design (March 2017 - May 2019). We also describe the implementation of the program during a longer time period (November 2016 - May 2019).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: In-Person Delivered Breast and Cervical Cancer Behavioral Intervention 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. |
Behavioral: Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).
Behavioral: Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
|
| Experimental: Telephone Delivered Breast and Cervical Cancer Behavioral Intervention 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. |
Behavioral: Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).
Behavioral: Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
|
Outcome Measures
Primary Outcome Measures
- Number of women 40 years and older who complete mammogram screening [Between baseline and end of study (about 9 months)]
Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
- Number of women 21-65 years old who complete Pap test screening [Between baseline and end of study (about 9 months)]
Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.
- Number of women 21-26 years old who initiate their HPV vaccination series. [between baseline and end of study (about 9 months)]
Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.
Secondary Outcome Measures
- Number of participants who received the second dose of HPV vaccine [between baseline and end of study (about 9 months)]
Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
- Number of participants who received the third dose of HPV vaccine [between baseline and end of study (about 9 months)]
Among women that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.
- Number of participants who received a clinical breast exam [between baseline and end of study (about 9 months)]
Among women that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Self identifies as Hispanic or Latina
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Lives in Texas
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Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
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Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
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HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
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Age limit for breast cancer screening group: 40 years and older
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Age limit for cervical cancer screening group (Pap test): 21 years and older
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Age limit for HPV vaccination group: 21-26 years
Exclusion Criteria:
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Current pregnancy
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Current or prior cancer diagnosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Cancer Prevention Research Institute of Texas
Investigators
- Principal Investigator: Lara Savas, PhD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-SPH-16-0159
- PP160047