Home Screening for Chlamydia Surveillance

Phase 3

Completed

• Conditions: Chlamydia Trachomatis; Gonorrhea

• Registration Number: NCT00177437
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 1999-06
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-12
• Last Update Posted: 2007-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 403

Inclusion Criteria

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

Exclusion Criteria

currently pregnant, homeless

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
chlamydia and gonorrhea tests completed
chlamydia and gonorrhea infections detected

Secondary Outcome Measures

Name	Time	Method
pelvic inflammatory disease cases detected

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States