Project Sexual Awareness for Everyone (SAFE)

This study is ongoing, but not recruiting participants.

First Received: March 21, 2008 Last Updated: May 1, 2008 History of Changes

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00643019

Purpose

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.

Condition	Intervention	Phase
Sexually Transmitted Disease Secondary Prevention Behavioral Modification Public Health	Behavioral: SAFE Behavioral Intervention Other: Control	Phase III

MedlinePlus related topics: Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preventing Recurrent Sexually Transmitted Infections in Minority Women

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Re-infection with a non-viral sexually transmitted infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in risky sexual behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	January 1993
Estimated Study Completion Date:	August 2008
Primary Completion Date:	January 1994 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SAFE Intervention: Experimental Behavioral Intervention	Behavioral: SAFE Behavioral Intervention Group cognitive behavioral intervention sessions
Control Sexually Transmitted Infection Risk Reduction Counseling	Other: Control Individual Sexually Transmitted Infection Risk Reduction Counseling

Detailed Description:

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

Eligibility

Ages Eligible for Study:	14 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-English speaking,
viral sexually transmitted infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643019

Locations

United States, Texas
University of Texas Health Sciences Center San Antonio
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator:

Rochelle N Shain, PhD

University of Texas Health Sciences Center San Antonio

More Information

No publications provided

Responsible Party:	University of Texas Health Sciences Center San Antonio ( Rochelle N Shain PhD, Joel Baseman PhD )
Study ID Numbers:	HSC2004415H, U01 AI40029
Study First Received:	March 21, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00643019 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

Sexually Transmitted Infections
Secondary Prevention
Cognitive Behavioral Intervention

Study placed in the following topic categories:

Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases

Neoplasm Metastasis
Genital Diseases, Male
Recurrence

Additional relevant MeSH terms:

Genital Diseases, Female
Virus Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes

Sexually Transmitted Diseases
Neoplasm Metastasis
Genital Diseases, Male
Infection

ClinicalTrials.gov processed this record on May 07, 2009