Project Sexual Awareness for Everyone (SAFE)

NCT ID: NCT00643019

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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

Conditions

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Sexually Transmitted Disease Secondary Prevention Behavioral Modification Public Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SAFE Intervention

Behavioral Intervention

Group Type EXPERIMENTAL

SAFE Behavioral Intervention

Intervention Type BEHAVIORAL

Group cognitive behavioral intervention sessions

Control

Sexually Transmitted Infection Risk Reduction Counseling

Group Type OTHER

Control

Intervention Type OTHER

Individual Sexually Transmitted Infection Risk Reduction Counseling

Interventions

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SAFE Behavioral Intervention

Group cognitive behavioral intervention sessions

Intervention Type BEHAVIORAL

Control

Individual Sexually Transmitted Infection Risk Reduction Counseling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-English speaking,
* viral sexually transmitted infection
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rochelle N Shain, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University of Texas Health Sciences Center San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18515527 (View on PubMed)

Other Identifiers

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U01AI040029

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC2004415H

Identifier Type: -

Identifier Source: org_study_id

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