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

Conditions

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

  • United States
    • 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
Behavioral: SAFE Behavioral Intervention
Group cognitive behavioral intervention sessions
Other: Control
Sexually Transmitted Infection Risk Reduction Counseling
Other: Control
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.

Sponsor

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

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.

General Publications

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

Keywords

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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