SEPA III: The Effectiveness Trial

University of Miami

Status: Completed

Conditions: HIV Prevention

Treatments: Behavioral: SEPA III

Study type: Interventional

Funder types: Other

Identifiers

NCT02405481

20120037

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Wait List Control

No Intervention group

SEPA III Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: SEPA III