Home Screening for Chlamydia Surveillance

Gonorrhea Clinical Trial

Official title:

Home Screening for Chlamydia Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177437
• Other study ID #: 0404024
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 12, 2007
• Start date: June 1999
• Est. completion date: September 2005

Study information

• Verified date: December 2007
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 29 Years

Eligibility

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

Exclusion Criteria: currently pregnant, homeless

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis
• Gonorrhea

Intervention

Behavioral:
• home testing kit

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chlamydia and gonorrhea tests completed
Primary	chlamydia and gonorrhea infections detected
Secondary	pelvic inflammatory disease cases detected