- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405481
SEPA III: The Effectiveness Trial (SEPA III)
May 17, 2018 updated by: Nilda Peragallo Montano, University of Miami
The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel.
The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.
Study Overview
Study Type
Interventional
Enrollment (Actual)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Hispanic Women,
- 18 to 50 years old,
- Sexually active in the past three months
Exclusion Criteria:
- Non-Hispanic,
- younger than 18,
- older than 50,
- not sexually active
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait List Control
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Experimental: SEPA III Intervention
SEPA brings together two important theoretical perspectives that will be effective and sustainable for HIV/AIDS prevention among Hispanic women in an inner city environment.
The content and learning strategies of SEPA are based on the social cognitive theory and of HIV/AIDS prevention that prior research has shown to be the most effective in increasing HIV/AIDS prevention behaviors, modified to take into account the special needs of Hispanic women related to gender inequality and cultural values and practices.
SEPA's conceptual framework integrates the Social Cognitive Model of behavioral change with Freire's Pedagogy of the Oppressed that guides the delivery and contextual tailoring.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Condom Use
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nilda Peragallo Montano, DrPH, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 24, 2015
First Submitted That Met QC Criteria
March 31, 2015
First Posted (Estimate)
April 1, 2015
Study Record Updates
Last Update Posted (Actual)
May 22, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 20120037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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