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

August 13, 2012
August 15, 2012
July 2007
December 2010   (final data collection date for primary outcome measure)
  • 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.
  • 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)
  • 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
Complete list of historical versions of study NCT01665690 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ascertined 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 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 ] [ 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
Not Provided
Not Provided
 
Washington State Community Expedited Partner Treatment (EPT) Trial
A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Gonorrhea
  • Neisseria Gonorrhoeae
  • Chlamydia Trachomatis
  • 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.
  • 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.
    Interventions:
    • Other: Patient delivered partner therapy
    • Behavioral: Targeted public health partner services
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33222
August 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01665690
29923-J, 5R01AI068107
No
Matthew Golden, University of Washington
University of Washington
  • Washington State, Department of Health
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Matthew Golden, MD University of Washington
University of Washington
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP