Home Screening for Chlamydia Surveillance

This study has been completed.

First Received: September 12, 2005 Last Updated: December 12, 2007 History of Changes

Sponsors and Collaborators:	University of Pittsburgh Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177437

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Home Screening for Chlamydia Surveillance

Resource links provided by NLM:

MedlinePlus related topics: Chlamydia Infections Gonorrhea

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 National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Feb 14.

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

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases
Chlamydia Infections

Gonorrhea
Genital Diseases, Male
Neisseriaceae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Genital Diseases, Female
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Chlamydiaceae Infections
Sexually Transmitted Diseases
Chlamydia Infections

Gonorrhea
Genital Diseases, Male
Infection
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 10, 2009