Gonorrhea Clinical Trial
Official title:
A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia
Verified date | August 2012 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United State: IRB |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Washington State Department of Health | Olympia | Washington |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Allergy and Infectious Diseases (NIAID), Washington State, Department of Health |
United States,
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
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 |
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