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NCT00112255 Clinical Trial

Partner Notification for Chlamydia in Primary Care

Chlamydia Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00112255
Other study ID # HTA_97/32/31
Secondary ID
Status Completed
Phase Phase 3
First received May 31, 2005
Last updated January 16, 2018
Start date March 2001
Est. completion date December 2002

Study information
Verified date January 2018
Source University of Bristol
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Practice nurse-led partner notification

• Referral to specialist genitourinary clinic

Locations
Country Name City State
United Kingdom Chlamydia Screening Studies (ClaSS) project general practices Birmingham West Midlands
United Kingdom Chlamydia Screening Studies (ClaSS) project general practices Bristol Avon

Sponsors (1)
Lead Sponsor Collaborator
University of Bristol

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of index cases with at least one sexual partner treated
Primary Number of sexual partners per index case treated
Secondary Number of sexual partners per index case elicited during sexual history taking
Secondary Positive chlamydia test result six weeks after treatment
Secondary Adherence to advice to abstain from sexual intercourse until both partners completed treatment
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