Project Sexual Awareness for Everyone (SAFE)

Preventing Recurrent Sexually Transmitted Infections in Minority Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643019

Acronym

SAFE

Enrollment

800

Registered

2008-03-25

Start date

1993-01-31

Completion date

2012-12-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Modification, Public Health, Secondary Prevention, Sexually Transmitted Disease

Keywords

Sexually Transmitted Infections, Secondary Prevention, Cognitive Behavioral Intervention

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.

Interventions

BEHAVIORALSAFE Behavioral Intervention

Group cognitive behavioral intervention sessions

OTHERControl

Individual Sexually Transmitted Infection Risk Reduction Counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Non-English speaking, * viral sexually transmitted infection

Design outcomes

Primary

Measure	Time frame
Re-infection with a non-viral sexually transmitted infection	1 year

Secondary

Measure	Time frame
Changes in risky sexual behavior	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026