Project Sexual Awareness for Everyone (SAFE)

Phase 3

Completed

• Conditions: Public Health; Sexually Transmitted Disease; Behavioral Modification; Secondary Prevention
• Interventions: Behavioral: SAFE Behavioral Intervention; Other: Control

• Registration Number: NCT00643019
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 1993-01
• Primary Completion: 1994-01
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

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

Exclusion Criteria

• Non-English speaking,
• viral sexually transmitted infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAFE Intervention	SAFE Behavioral Intervention	Behavioral Intervention
Control	Control	Sexually Transmitted Infection Risk Reduction Counseling

Primary Outcome Measures

Name	Time	Method
Re-infection with a non-viral sexually transmitted infection	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in risky sexual behavior	2 years

Trial Locations

Locations (1)

University of Texas Health Sciences Center San Antonio; 🇺🇸 San Antonio, Texas, United States