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Home Screening for Chlamydia Surveillance

This study has been completed.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177437
First received: September 12, 2005
Last updated: December 12, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Chlamydia Trachomatis
Gonorrhea
 Behavioral: home testing kit
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Home Screening for Chlamydia Surveillance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • chlamydia and gonorrhea tests completed
  • chlamydia and gonorrhea infections detected

Secondary Outcome Measures:
  • pelvic inflammatory disease cases detected

Estimated Enrollment: 403
Study Start Date: June 1999
Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active -

Exclusion Criteria: currently pregnant, homeless

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177437

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Roberta B Ness, MD, MPH University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00177437     History of Changes
Other Study ID Numbers: 0404024
Study First Received: September 12, 2005
Last Updated: December 12, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
 Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 16, 2013