Washington State Community Expedited Partner Treatment (EPT) Trial

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665690
• Other study ID #: 29923-J
• Secondary ID: 5R01AI068107
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2012
• Last updated: August 15, 2012
• Start date: July 2007
• Est. completion date: August 2011

Study information

• Verified date: August 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United State: IRB
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33222
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis
• Gonorrhea
• Neisseria Gonorrhoeae

Intervention

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.

Locations

Country	Name	City	State
United States	Washington State Department of Health	Olympia	Washington
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Allergy and Infectious Diseases (NIAID), Washington State, Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test positivity for Chlamydia trachomatis among women age 15-25	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.	October 2006 - December 2010	No
Primary	Gonorrhea incidence in women	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.	October 2007-December 2010	No
Secondary	Rates of recurrent gonorrhea	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	October 2007-Dec 2010	No
Secondary	Recurrent chlamydial infection	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	October 2006 - December 2010	No
Secondary	Reported adverse drug reactions	Adverse drug reactions reported to study staff following ingestion of medication supplied at patient delivered partner therapy. Outcome ascertained through passive surveillance.	July 2007-December 2010	Yes
Secondary	Use of patient delivered partner therapy (PDPT) by medical providers	Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men	July 2007 - December 2010	No