Washington State Community Expedited Partner Treatment (EPT) Trial

NCT ID: NCT01665690

Last Updated: 2012-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Gonorrhea Neisseria Gonorrhoeae Chlamydia Trachomatis

Keywords

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patient delivered partner therapy expedited partner therapy partner notification gonorrhea chlamydia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient delivered partner therapy

Intervention Type OTHER

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.

Targeted public health partner services

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* MSM
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington State, Department of Health

OTHER_GOV

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Matthew Golden

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Golden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Washington State Department of Health

Olympia, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Golden MR, Hughes JP, Brewer DD, Holmes KK, Whittington WL, Hogben M, Malinski C, Golding A, Handsfield HH. Evaluation of a population-based program of expedited partner therapy for gonorrhea and chlamydial infection. Sex Transm Dis. 2007 Aug;34(8):598-603. doi: 10.1097/01.olq.0000258319.54316.06.

Reference Type BACKGROUND
PMID: 17413683 (View on PubMed)

Golden MR, Kerani RP, Stenger M, Hughes JP, Aubin M, Malinski C, Holmes KK. Uptake and population-level impact of expedited partner therapy (EPT) on Chlamydia trachomatis and Neisseria gonorrhoeae: the Washington State community-level randomized trial of EPT. PLoS Med. 2015 Jan 15;12(1):e1001777. doi: 10.1371/journal.pmed.1001777. eCollection 2015 Jan.

Reference Type DERIVED
PMID: 25590331 (View on PubMed)

Other Identifiers

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5R01AI068107

Identifier Type: NIH

Identifier Source: secondary_id

View Link

29923-J

Identifier Type: -

Identifier Source: org_study_id