GonorrheaPhase 4NCT01665690
Washington State Community Expedited Partner Treatment (EPT) Trial
A Phase 4 study testing Patient delivered partner therapy and Targeted public health partner services in people with Gonorrhea and Neisseria Gonorrhoeae, run by University of Washington at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Gonorrhea, Neisseria Gonorrhoeae, Chlamydia Trachomatis
- What is being tested?
- Patient delivered partner therapy and Targeted public health partner services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,222 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All non-MSM with gonorrhea or chlamydial infection will be eligible for the study intervention.
Who cannot join
- MSM
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington State Department of Health
Olympia, Washington, 98504-7890
University of Washington
Seattle, Washington, 98104
About this study
Official title: 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.
- Conditions
- Gonorrhea, Neisseria Gonorrhoeae, Chlamydia Trachomatis
- Being tested
- Patient delivered partner therapy, Targeted public health partner services
- Keywords
- patient delivered partner therapy, expedited partner therapy, partner notification, gonorrhea, chlamydia
- Medical subject headings
- Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient delivered partner therapyOther
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.
Targeted public health partner servicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention period | Experimental | 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. Receives: Other: Patient delivered partner therapy; Behavioral: Targeted public health partner services |
| Control Period | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: October 2006 - December 2010
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.
Measured: October 2007-December 2010
Secondary outcomes (4)
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
Measured: October 2007-Dec 2010
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
Measured: October 2006 - December 2010
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.
Measured: July 2007-December 2010
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
Measured: July 2007 - December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State, Department of Health, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Matthew Golden, University of Washington
- Investigators
- Matthew Golden, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665690
- Sponsor's protocol ID
- 29923-J
- Other IDs
- 5R01AI068107
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17413683Golden 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.
PubMed 25590331
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia
- ClinicalTrials.gov ID
- NCT01665690
- Acronym / sponsor ID
- 29923-J
- Conditions
- Gonorrhea, Neisseria Gonorrhoeae, Chlamydia Trachomatis
- Keywords
- patient delivered partner therapy, expedited partner therapy, partner notification, gonorrhea, chlamydia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33,222 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Washington State, Department of Health, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention period | Experimental | Other: Patient delivered partner therapy, Behavioral: Targeted public health partner servicesThe 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. |
| Control Period | No intervention | –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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All non-MSM with gonorrhea or chlamydial infection will be eligible for the study intervention.
Key exclusion criteria (1 listed)
- MSM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient delivered partner therapyThe 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. | Other | Intervention period |
| Targeted public health partner servicesDuring 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. | Behavioural | Intervention period |
Primary outcome
Test positivity for Chlamydia trachomatis among women age 15-25
Time frame: October 2006 - December 2010
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
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.
4 secondary outcomes
Rates of recurrent gonorrhea
Time frame: October 2007-Dec 2010
Recurrent chlamydial infection
Time frame: October 2006 - December 2010
Reported adverse drug reactions
Time frame: July 2007-December 2010
Use of patient delivered partner therapy (PDPT) by medical providers
Time frame: July 2007 - December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Background: PubMed 17413683Golden 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.
- Derived from this study: PubMed 25590331Golden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Golden, MD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patient delivered partner therapy and Targeted public health partner services in people with Gonorrhea and Neisseria Gonorrhoeae, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test positivity for Chlamydia trachomatis among women age 15-25 (time frame: October 2006 - December 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.