Washington State Community Expedited Partner Treatment (EPT) Trial

This study has been completed.
Sponsor:
Collaborators:
Washington State, Department of Health
Information provided by (Responsible Party):
Matthew Golden, University of Washington
ClinicalTrials.gov Identifier:
NCT01665690
First received: August 13, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Gonorrhea
Neisseria Gonorrhoeae
Chlamydia Trachomatis
Other: Patient delivered partner therapy
Behavioral: Targeted public health partner services
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Test positivity for Chlamydia trachomatis among women age 15-25 [ Time Frame: October 2006 - December 2010 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: October 2007-Dec 2010 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men


Enrollment: 33222
Study Start Date: July 2007
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Inclusion Criteria:

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

Exclusion Criteria:

  • MSM
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665690

Locations
United States, Washington
Washington State Department of Health
Olympia, Washington, United States, 98504-7890
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Washington State, Department of Health
Investigators
Principal Investigator: Matthew Golden, MD University of Washington
  More Information

Publications:
Responsible Party: Matthew Golden, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01665690     History of Changes
Other Study ID Numbers: 29923-J, 5R01AI068107
Study First Received: August 13, 2012
Last Updated: August 15, 2012
Health Authority: United State: IRB

Keywords provided by University of Washington:
patient delivered partner therapy
expedited partner therapy
partner notification
gonorrhea
chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 01, 2014