Clinical trial NCT01665690: Washington State Community Expedited Partner Treatment (EPT) Trial
Official title: A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gonorrhea
Neisseria Gonorrhoeae
Chlamydia Trachomatis
Keywords: patient delivered partner therapy
expedited partner therapy
partner notification
gonorrhea
chlamydia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Washington State, Department of Health
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2012-08-15
Enrollment: 33222
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Test positivity for Chlamydia trachomatis among women age 15-25
timeFrame: October 2006 - December 2010
measure: Gonorrhea incidence in women
timeFrame: October 2007-December 2010
Secondary outcomes:
measure: Rates of recurrent gonorrhea
timeFrame: October 2007-Dec 2010
measure: Recurrent chlamydial infection
timeFrame: October 2006 - December 2010
measure: Reported adverse drug reactions
timeFrame: July 2007-December 2010
measure: Use of patient delivered partner therapy (PDPT) by medical providers
timeFrame: July 2007 - December 2010
Other outcomes:
Locations:
city: Olympia
country: United States
facility: Washington State Department of Health
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Matthew Golden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.