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Project Sexual Awareness for Everyone (SAFE) (SAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00643019
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Disease Secondary Prevention Behavioral Modification Public Health Behavioral: SAFE Behavioral Intervention Other: Control Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
Study Start Date : January 1993
Primary Completion Date : January 1994
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SAFE Intervention
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


Outcome Measures

Primary Outcome Measures :
  1. Re-infection with a non-viral sexually transmitted infection [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes in risky sexual behavior [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 The University of Texas Health Science Center at San Antonio
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00643019     History of Changes
Other Study ID Numbers: HSC2004415H
U01AI040029 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by The University of Texas Health Science Center at San Antonio:
Sexually Transmitted Infections
Secondary Prevention
Cognitive Behavioral Intervention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female