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OpenTrials
Completed

NCT Number: NCT00643019

Project Sexual Awareness for Everyone (SAFE)

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.

Completed

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Key information

Conditions

Sexually Transmitted Disease Behavioral Modification Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Public Health Secondary Prevention Sexually Transmitted Diseases Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas Health Sciences Center San Antonio

San Antonio, Texas, 78229-3900, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-English speaking,
  • viral sexually transmitted infection

Treatment and study plan

SAFE Behavioral Intervention

Behavioral

Group cognitive behavioral intervention sessions

Control

Other

Individual Sexually Transmitted Infection Risk Reduction Counseling

Primary outcomes

  1. Re-infection with a non-viral sexually transmitted infection

    Time frame: 1 year

Secondary outcomes

  1. Changes in risky sexual behavior

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Preventing Recurrent Sexually Transmitted Infections in Minority Women

Acronym: SAFE

Important dates

Study start
1993
Primary completion
1994
Study completion
2012
First posted
Mar 25, 2008
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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