NCT02405481

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

March 24, 2015

Last Update Submit

May 17, 2018

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Condom Use

    1 year

Study Arms (2)

Wait List Control

NO INTERVENTION

SEPA III Intervention

EXPERIMENTAL

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.

Behavioral: SEPA III

Interventions

SEPA IIIBEHAVIORAL
SEPA III Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hispanic Women,
  • to 50 years old,
  • Sexually active in the past three months

You may not qualify if:

  • Non-Hispanic,
  • younger than 18,
  • older than 50,
  • not sexually active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

  • Nilda Peragallo Montano, DrPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean and Professor

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 1, 2015

Study Start

June 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

US(1)