Project Sexual Awareness for Everyone (SAFE)

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Public Health; Behavioral Modification; Secondary Prevention; Sexually Transmitted Disease

Treatments: Behavioral: SAFE Behavioral Intervention; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00643019

U01AI040029 (U.S. NIH Grant/Contract)

HSC2004415H

Details and patient eligibility

About

This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.

Full description

Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.

Enrollment: 800 estimated patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mexican American,
• 14 - 45 years old,
• English Speaking,
• non-viral sexually transmitted infection

Exclusion criteria

• Non-English speaking,
• viral sexually transmitted infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

SAFE Intervention

Experimental group

Description:

Behavioral Intervention

Treatment:

Behavioral: SAFE Behavioral Intervention

Control

Other group

Description:

Sexually Transmitted Infection Risk Reduction Counseling

Treatment:

Other: Control