Partner Notification for Chlamydia in Primary Care

January 16, 2018 updated by: University of Bristol

Partner Notification for Chlamydia in Primary Care: Randomised Controlled Trial and Economic Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS8 2PR
        • Chlamydia Screening Studies (ClaSS) project general practices
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • Chlamydia Screening Studies (ClaSS) project general practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of index cases with at least one sexual partner treated
Number of sexual partners per index case treated

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bristol

Investigators

  • Study Director: Nicola Low, MFPH, Chlamydia Screening Studies (ClaSS) project general practices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

May 31, 2005

First Submitted That Met QC Criteria

May 31, 2005

First Posted (Estimate)

June 1, 2005

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTA_97/32/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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