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Partner Notification for Chlamydia in Primary Care

Primary Purpose

Chlamydia Infections

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Practice nurse-led partner notification
Referral to specialist genitourinary clinic
Sponsored by
University of Bristol
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chlamydia Infections focused on measuring Chlamydia trachomatis, Chlamydia infections, Randomized controlled trials, Contact tracing, Family practice

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chlamydia Screening Studies (ClaSS) project general practices
  • Chlamydia Screening Studies (ClaSS) project general practices

Outcomes

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

Full Information

First Posted
May 31, 2005
Last Updated
January 16, 2018
Sponsor
University of Bristol
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1. Study Identification

Unique Protocol Identification Number
NCT00112255
Brief Title
Partner Notification for Chlamydia in Primary Care
Official Title
Partner Notification for Chlamydia in Primary Care: Randomised Controlled Trial and Economic Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bristol

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Infections
Keywords
Chlamydia trachomatis, Chlamydia infections, Randomized controlled trials, Contact tracing, Family practice

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Practice nurse-led partner notification
Intervention Type
Behavioral
Intervention Name(s)
Referral to specialist genitourinary clinic
Primary Outcome Measure Information:
Title
Percentage of index cases with at least one sexual partner treated
Title
Number of sexual partners per index case treated
Secondary Outcome Measure Information:
Title
Number of sexual partners per index case elicited during sexual history taking
Title
Positive chlamydia test result six weeks after treatment
Title
Adherence to advice to abstain from sexual intercourse until both partners completed treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Low, MFPH
Organizational Affiliation
Chlamydia Screening Studies (ClaSS) Project General Practices
Official's Role
Study Director
Facility Information:
Facility Name
Chlamydia Screening Studies (ClaSS) project general practices
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS8 2PR
Country
United Kingdom
Facility Name
Chlamydia Screening Studies (ClaSS) project general practices
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15459400
Citation
Low N, McCarthy A, Macleod J, Salisbury C, Horner PJ, Roberts TE, Campbell R, Herring A, Skidmore S, Sanford E, Sterne JA, Davey Smith G, Graham A, Huengsberg M, Ross J, Egger M. The chlamydia screening studies: rationale and design. Sex Transm Infect. 2004 Oct;80(5):342-8. doi: 10.1136/sti.2003.006197.
Results Reference
background
PubMed Identifier
16356945
Citation
Low N, McCarthy A, Roberts TE, Huengsberg M, Sanford E, Sterne JA, Macleod J, Salisbury C, Pye K, Holloway A, Morcom A, Patel R, Robinson SM, Horner P, Barton PM, Egger M. Partner notification of chlamydia infection in primary care: randomised controlled trial and analysis of resource use. BMJ. 2006 Jan 7;332(7532):14-9. doi: 10.1136/bmj.38678.405370.7C. Epub 2005 Dec 15.
Results Reference
result

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Partner Notification for Chlamydia in Primary Care

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