NCT00177437

Brief Summary

This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 1999

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 12, 2007

Conditions

Chlamydia TrachomatisGonorrhea

Outcome Measures

Primary Outcomes (2)

  • chlamydia and gonorrhea tests completed

  • chlamydia and gonorrhea infections detected

Secondary Outcomes (1)

  • pelvic inflammatory disease cases detected

Interventions

home testing kitBEHAVIORAL

Eligibility Criteria

Age15 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Cook RL, Ostergaard L, Hillier SL, Murray PJ, Chang CC, Comer DM, Ness RB; DAISY study team. Home screening for sexually transmitted diseases in high-risk young women: randomised controlled trial. Sex Transm Infect. 2007 Jul;83(4):286-91. doi: 10.1136/sti.2006.023762. Epub 2007 Feb 14.

    PMID: 17301105DERIVED

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Roberta B Ness, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 1999

Study Completion

September 1, 2005

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

US(1)