Washington State Community Expedited Partner Treatment (EPT) Trial

Phase 4

Completed

• Conditions: Gonorrhea; Neisseria Gonorrhoeae; Chlamydia Trachomatis
• Interventions: Other: Patient delivered partner therapy; Behavioral: Targeted public health partner services

• Registration Number: NCT01665690
• Lead Sponsor: University of Washington

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 Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2010-12
• Study Completion: 2011-08
• Status Verified: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33222

Inclusion Criteria

• All non-MSM with gonorrhea or chlamydial infection will be eligible for the study intervention.

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Exclusion Criteria

• MSM

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention period	Patient delivered partner therapy	The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.
Intervention period	Targeted public health partner services	The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.

Primary Outcome Measures

Name	Time	Method
Gonorrhea incidence in women	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.
Test positivity for Chlamydia trachomatis among women age 15-25	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.

Secondary Outcome Measures

Name	Time	Method
Rates of recurrent gonorrhea	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	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	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	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

Trial Locations

Locations (2)

Washington State Department of Health; 🇺🇸 Olympia, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States