NCT00643019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 1993

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1993

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1994

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

March 21, 2008

Last Update Submit

April 14, 2015

Conditions

Sexually Transmitted DiseaseSecondary PreventionBehavioral ModificationPublic Health

Keywords

Sexually Transmitted InfectionsSecondary PreventionCognitive Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Re-infection with a non-viral sexually transmitted infection

    1 year

Secondary Outcomes (1)

  • Changes in risky sexual behavior

    2 years

Study Arms (2)

SAFE Intervention

EXPERIMENTAL

Behavioral Intervention

Behavioral: SAFE Behavioral Intervention

Control

OTHER

Sexually Transmitted Infection Risk Reduction Counseling

Other: Control

Interventions

SAFE Behavioral InterventionBEHAVIORAL

Group cognitive behavioral intervention sessions

SAFE Intervention
ControlOTHER

Individual Sexually Transmitted Infection Risk Reduction Counseling

Control

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Non-English speaking,
  • viral sexually transmitted infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Sciences Center San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (1)

  • 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.

    PMID: 18515527DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rochelle N Shain, PhD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

January 1, 1993

Primary Completion

January 1, 1994

Study Completion

December 1, 2012

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)