SEPA III: The Effectiveness Trial

NCT ID: NCT02405481

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wait List Control

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

SEPA III

Intervention Type BEHAVIORAL

Interventions

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SEPA III

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Nilda Peragallo Montano

Dean and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilda Peragallo Montano, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20120037

Identifier Type: -

Identifier Source: org_study_id

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