Project Sexual Awareness for Everyone (SAFE)

Public Health Clinical Trial

— SAFE  

Official title:

Preventing Recurrent Sexually Transmitted Infections in Minority Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643019
• Other study ID #: HSC2004415H
• Secondary ID: U01AI040029
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2008
• Last updated: April 14, 2015
• Start date: January 1993
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2012
• Est. primary completion date: January 1994
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavioral Modification
• Public Health
• Secondary Prevention
• Sexually Transmitted Disease
• Sexually Transmitted Diseases

Intervention

Behavioral:
• SAFE Behavioral Intervention
Group cognitive behavioral intervention sessions

Other:
• Control
Individual Sexually Transmitted Infection Risk Reduction Counseling

Locations

Country	Name	City	State
United States	University of Texas Health Sciences Center San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-infection with a non-viral sexually transmitted infection		1 year	No
Secondary	Changes in risky sexual behavior		2 years	No