Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A
Completed NCT03294395 - New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea Phase 3
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03896776 - A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0) N/A
Completed NCT03718806 - Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin Phase 1
Completed NCT04010539 - A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Phase 3
Completed NCT00262106 - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection Phase 3
Completed NCT00187902 - Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM N/A
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT04553068 - Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection Phase 3
Active, not recruiting NCT03959527 - Zoliflodacin in Uncomplicated Gonorrhoea Phase 3
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Terminated NCT00120770 - Cellulose Sulfate (CS) Gel and HIV in Nigeria Phase 3
Completed NCT02391233 - Multimedia WORTH With Black Drug-Involved Women on Probation N/A
Recruiting NCT05766904 - Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections Phase 3
Completed NCT04297436 - Gonococcal Vaccine Study in Key Populations in Kenya N/A
Completed NCT03098329 - Check it: A New Approach to Controlling Chlamydia Transmission in Young People N/A
Completed NCT02122094 - Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities N/A