Back to resultsHome Screening for Chlamydia Surveillance
Primary Purpose
Chlamydia Trachomatis, Gonorrhea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
home testing kit
Sponsored by
About this trial
This is an interventional prevention trial for Chlamydia Trachomatis
Eligibility Criteria
Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active - Exclusion Criteria: currently pregnant, homeless -
Sites / Locations
- University of Pittsburgh
Outcomes
Primary Outcome Measures
chlamydia and gonorrhea tests completed
chlamydia and gonorrhea infections detected
Secondary Outcome Measures
pelvic inflammatory disease cases detected
Full Information
NCT ID
NCT00177437
First Posted
September 12, 2005
Last Updated
December 12, 2007
Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00177437
Brief Title
Home Screening for Chlamydia Surveillance
Official Title
Home Screening for Chlamydia Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
5. Study Description
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.
Detailed Description
This is a phase III randomized controlled trial. We enrolled 403 young women from a variety of clinical settings and neighborhoods in the Pittsburgh, PA region. Women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). Participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. The final study end points were number of tests completed, number of screening tests completed, number of STDs detected, and incident cases of pelvic inflammatory disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis, Gonorrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
403 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
home testing kit
Primary Outcome Measure Information:
Title
chlamydia and gonorrhea tests completed
Title
chlamydia and gonorrhea infections detected
Secondary Outcome Measure Information:
Title
pelvic inflammatory disease cases detected
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active -
Exclusion Criteria: currently pregnant, homeless
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta B Ness, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17301105
Citation
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.
Results Reference
derived
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Home Screening for Chlamydia Surveillance
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