Washington State Community Expedited Partner Treatment (EPT) Trial

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01665690

Collaborator

Washington State, Department of Health (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

33,222

Enrollment

Locations

Arms

Duration (Months)

16611

Patients Per Site

338.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gonorrhea Neisseria Gonorrhoeae Chlamydia Trachomatis	Other: Patient delivered partner therapy Behavioral: Targeted public health partner services	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

33222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention period 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.	Other: Patient delivered partner therapy The study will provide communities with access to free PDPT for heterosexuals with gonorrhea or chlamydial infection. PDPT will be packaged to meet the requirements of the WA State Board of Pharmacy and will include 1gram of azithromycin, information about STD, condoms, and information about enclosed medication in English and Spanish. PDPT packs for gonorrhea will also include 400mg of cefixime. Behavioral: Targeted public health partner services During intervention periods, communities will receive public health partner services (PS) provided by Disease Intervention Specialists (DIS). Diagnosing clinicians will triage their patients to receive PS based on defined criteria associated with not ensuring partners' treatment. PS will include an offer to notify partners for each index case. When DIS notify partners they will offer them the opportunity to obtain free medication at a local pharmacy, at a clinic (as available) or through the mail. DIS will also offer to refer partners for complete evaluations insofar as such care is available in local communities.
No Intervention: Control Period 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.

Arm

Intervention/Treatment

Experimental: Intervention period

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.

Other: Patient delivered partner therapy

The study will provide communities with access to free PDPT for heterosexuals with gonorrhea or chlamydial infection. PDPT will be packaged to meet the requirements of the WA State Board of Pharmacy and will include 1gram of azithromycin, information about STD, condoms, and information about enclosed medication in English and Spanish. PDPT packs for gonorrhea will also include 400mg of cefixime.

Behavioral: Targeted public health partner services

During intervention periods, communities will receive public health partner services (PS) provided by Disease Intervention Specialists (DIS). Diagnosing clinicians will triage their patients to receive PS based on defined criteria associated with not ensuring partners' treatment. PS will include an offer to notify partners for each index case. When DIS notify partners they will offer them the opportunity to obtain free medication at a local pharmacy, at a clinic (as available) or through the mail. DIS will also offer to refer partners for complete evaluations insofar as such care is available in local communities.

No Intervention: Control Period

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

With reference to the above question about sampling, we will measure PDPT use in a probability sample of persons with STD. Chlamydial prevalence will be measured in a sentinel population. Gonorrhea incidence will be based on public health surveillance.