Clinical Trial: Washington State Community Expedited Partner Treatment (EPT) Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia

Brief Summary: The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community level randomized trial designed to test the hypothesis that a public health program designed to increase the use of expedited partner therapy can decrease the prevalence of chlamydial infection in young women and the incidence of gonorrhea in Washington state. The study intervention will be modeled after and intervention previously evaluated in King County WA (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion of patient delivered partner therapy (PDPT) use by medical providers in accordance with Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be promoted through education and by making medication packs for PDPT available statewide. Medical providers will refer selected persons with gonorrhea or chlamydial infection for partner services based on defined criteria associated with failure to ensure partners' treatment. The intervention will be instituted in four waves separated by 6-9 months. Each wave will include approximately 6 local health jurisdictions. The order in which health jurisdictions initiate the intervention will be randomly assigned. The study's primary endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through clinics participating in the state's Infertility Prevention Project (IPP) and the incidence of gonorrhea among women as determined through public health reporting.

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome:

• Test positivity for Chlamydia trachomatis among women age 15-25 [ Time Frame: October 2006 - December 2010 ]
  The proportion of women age 15-25 testing positive for C. trachomatis in clinics participating in the WA State Infertility Prevention Project (IPP). Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.
• Gonorrhea incidence in women [ Time Frame: October 2007-December 2010 ]
  The incidence of gonorrhea in women in WA state local health jurisdictions as ascertained through public health reporting. Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.

Original Primary Outcome:

• Test positivity for Chlamydia trachomatis among women age 15-25 [ Time Frame: October 2006 - December 2010 ]
  The proportion of women age 15-25 testing positive for C. trachomatis in clinics participating in the WA State Infertility Prevention Project (IPP)
• Gonorrhea incidence in women [ Time Frame: October 2007-December 2010 ]
  The incidence of gonorrhea in women in WA state local health jurisdictions as ascertained through public health reporting

Current Secondary Outcome:

• Rates of recurrent gonorrhea [ Time Frame: October 2007-Dec 2010 ]
  Proportion of men and women with a second episode of gonorrhea occuring within 6 months of their initial diagnosis as ascertained through public health surveillance
• Recurrent chlamydial infection [ Time Frame: October 2006 - December 2010 ]
  Proportion of men and women with a second episode of chlamydial infection occuring within 6 months of their initial diagnosis as ascertained through public health surveillance
• Reported adverse drug reactions [ Time Frame: July 2007-December 2010 ]
  Adverse drug reactions reported to study staff following ingestion of medication supplied at patient delivered partner therapy. Outcome ascertained through passive surveillance.
• Use of patient delivered partner therapy (PDPT) by medical providers [ Time Frame: July 2007 - December 2010 ]
  Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men

Original Secondary Outcome:

• Rates of recurrent gonorrhea [ Time Frame: October 2007-Dec 2010 ]
  Proportion of men and women with a second episode of gonorrhea occuring within 6 months of their initial diagnosis as ascertined through public health surveillance
• Recurrent chlamydial infection [ Time Frame: October 2006 - December 2010 ]
  Proportion of men and women with a second episode of chlamdyial infection occuring within 6 months of their initial diagnosis as ascertined through public health surveillance
• Reported adverse drug reactions [ Time Frame: July 2007-December 2010 ]
  Adverse drug reactions reported to study staff following ingestion of medication supplied at patient delivered partner therapy. Outcome ascertained through passive surveillance.
• Use of patient delivered partner therapy (PDPT) by medical providers [ Time Frame: July 2007 - December 2010 ]
  Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men

Information By: University of Washington

Dates:
Date Received: August 13, 2012
Date Started: July 2007
Date Completion:
Last Updated: August 15, 2012
Last Verified: August 2012