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Partner Notification for Chlamydia in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112255
First Posted: June 1, 2005
Last Update Posted: May 10, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bristol
  Purpose
The purpose of this study was to compare the effectiveness of partner notification by general practice nurses with referral to a specialist clinic for people with genital chlamydia diagnosed in a community setting. We hypothesised that referral to a specialist would be more effective in ensuring treatment of the sexual partners of infected people than the simpler nurse-led strategy.

Condition Intervention Phase
Chlamydia Infections Behavioral: Practice nurse-led partner notification Behavioral: Referral to specialist genitourinary clinic Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Partner Notification for Chlamydia in Primary Care: Randomised Controlled Trial and Economic Evaluation

Resource links provided by NLM:


Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • Percentage of index cases with at least one sexual partner treated
  • Number of sexual partners per index case treated

Secondary Outcome Measures:
  • Number of sexual partners per index case elicited during sexual history taking
  • Positive chlamydia test result six weeks after treatment
  • Adherence to advice to abstain from sexual intercourse until both partners completed treatment

Estimated Enrollment: 214
Study Start Date: March 2001
Estimated Study Completion Date: December 2002
Detailed Description:

Partner notification (contact tracing) is essential to the control of sexually transmitted infections. Reports of new chlamydia infections have increased by 66% in the past five years. A National Chlamydia Screening Programme in England, and increasing primary care provision of sexual health care are part of the United Kingdom Government’s strategy for tackling increasing rates of sexually transmitted infections. New strategies for managing chlamydia in non-specialist settings are urgently required: genitourinary medicine clinics are failing to cope with their increasing workload; and 45% of cases detected in the chlamydia screening pilot studies were diagnosed in general practice.

Partner notification involves informing the sexual partners of someone with a sexually transmitted infection of the possibility of exposure, offering them diagnosis and treatment, and providing advice about preventing future infection. In the United Kingdom, this is usually done by specialist sexual health advisers in departments of genitourinary medicine. The effectiveness of partner notification in non-specialist settings in developed countries is not known. We conducted a randomised controlled trial to compare the effectiveness of practice nurse-led partner notification with referral to a genitourinary clinic for partner notification conducted by a specialist health adviser, and to compare the resources used by each strategy.

Comparisons: Partner notification at the time of receiving diagnosis and treatment by general practice nurses who received a one-day training course and ongoing support by telephone calls or visits from a specialist adviser in sexual health, compared with referral to a genitourinary medicine clinic for partner notification by a specialist adviser in sexual health.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chlamydia trachomatis diagnosed through a population-based screening study
  • Chlamydia test result received at patient's general practice
  • Chlamydia cases diagnosed in general practice

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112255


Locations
United Kingdom
Chlamydia Screening Studies (ClaSS) project general practices
Bristol, Avon, United Kingdom, BS8 2PR
Chlamydia Screening Studies (ClaSS) project general practices
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
University of Bristol
Investigators
Study Director: Nicola Low, MFPH Chlamydia Screening Studies (ClaSS) Project General Practices
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00112255     History of Changes
Other Study ID Numbers: HTA_97/32/31
First Submitted: May 31, 2005
First Posted: June 1, 2005
Last Update Posted: May 10, 2006
Last Verified: May 2005

Keywords provided by University of Bristol:
Chlamydia trachomatis
Chlamydia infections
Randomized controlled trials
Contact tracing
Family practice

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female