- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00643019
Project Sexual Awareness for Everyone (SAFE) (SAFE)
April 14, 2015 updated by: The University of Texas Health Science Center at San Antonio
Preventing Recurrent Sexually Transmitted Infections in Minority Women
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229-3900
- University of Texas Health Sciences Center San Antonio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAFE Intervention
Behavioral Intervention
|
Group cognitive behavioral intervention sessions
|
Other: Control
Sexually Transmitted Infection Risk Reduction Counseling
|
Individual Sexually Transmitted Infection Risk Reduction Counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Re-infection with a non-viral sexually transmitted infection
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in risky sexual behavior
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rochelle N Shain, PhD, The University of Texas Health Science Center at San Antonio
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1993
Primary Completion (Actual)
January 1, 1994
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 21, 2008
First Submitted That Met QC Criteria
March 24, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC2004415H
- U01AI040029 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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