Home Screening for Chlamydia Surveillance

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177437
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 403
• Location: 1
• Duration (Months): 75
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chlamydia Trachomatis; Gonorrhea	Behavioral: home testing kit	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Home Screening for Chlamydia Surveillance
• Study Start Date: Jun 1, 1999
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. chlamydia and gonorrhea tests completed []

2. chlamydia and gonorrhea infections detected []

Secondary Outcome Measures

1. pelvic inflammatory disease cases detected []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 29 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Exclusion Criteria: currently pregnant, homeless

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00177437
• Other Study ID Numbers: 0404024
• First Posted: Sep 15, 2005
• Last Update Posted: Dec 13, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Chlamydia Infections; Gonorrhea

Study Results

No Results Posted as of Dec 13, 2007