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Project Sexual Awareness for Everyone (SAFE) (SAFE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00643019
First received: March 21, 2008
Last updated: April 14, 2015
Last verified: April 2015
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Recurrent Sexually Transmitted Infections in Minority Women

Resource links provided by NLM:


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
Study Completion Date: December 2012
Primary Completion Date: January 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 
Study First Received: March 21, 2008
Last Updated: April 14, 2015
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

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

ClinicalTrials.gov processed this record on September 27, 2016