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Project Sexual Awareness for Everyone (SAFE) (SAFE)

Primary Purpose

Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SAFE Behavioral Intervention
Control
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Disease focused on measuring Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking,
  • viral sexually transmitted infection

Sites / Locations

  • University of Texas Health Sciences Center San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SAFE Intervention

Control

Arm Description

Behavioral Intervention

Sexually Transmitted Infection Risk Reduction Counseling

Outcomes

Primary Outcome Measures

Re-infection with a non-viral sexually transmitted infection

Secondary Outcome Measures

Changes in risky sexual behavior

Full Information

First Posted
March 21, 2008
Last Updated
April 14, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT00643019
Brief Title
Project Sexual Awareness for Everyone (SAFE)
Acronym
SAFE
Official Title
Preventing Recurrent Sexually Transmitted Infections in Minority Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
January 1994 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Disease, Secondary Prevention, Behavioral Modification, Public Health
Keywords
Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAFE Intervention
Arm Type
Experimental
Arm Description
Behavioral Intervention
Arm Title
Control
Arm Type
Other
Arm Description
Sexually Transmitted Infection Risk Reduction Counseling
Intervention Type
Behavioral
Intervention Name(s)
SAFE Behavioral Intervention
Intervention Description
Group cognitive behavioral intervention sessions
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Individual Sexually Transmitted Infection Risk Reduction Counseling
Primary Outcome Measure Information:
Title
Re-infection with a non-viral sexually transmitted infection
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in risky sexual behavior
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rochelle N Shain, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Sciences Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18515527
Citation
Thurman AR, Holden AE, Shain RN, Perdue S, Piper JM. Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1417-25. doi: 10.1097/AOG.0b013e318177143a.
Results Reference
derived

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Project Sexual Awareness for Everyone (SAFE)

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