Chlamydia InfectionsPhase 3NCT00112255
Partner Notification for Chlamydia in Primary Care
A Phase 3 study testing Practice nurse-led partner notification and Referral to specialist genitourinary clinic in people with Chlamydia Infections, run by University of Bristol at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chlamydia Infections
- What is being tested?
- Practice nurse-led partner notification and Referral to specialist genitourinary clinic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 214 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2001to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chlamydia trachomatis diagnosed through a population-based screening study
- Chlamydia test result received at patient's general practice
- Chlamydia cases diagnosed in general practice
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chlamydia Screening Studies (ClaSS) project general practices
Birmingham, West Midlands, B15 2TT
Chlamydia Screening Studies (ClaSS) project general practices
Bristol, Avon, BS8 2PR
About this study
Official title: 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.
Read the 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.
- Conditions
- Chlamydia Infections
- Being tested
- Practice nurse-led partner notification, Referral to specialist genitourinary clinic
- Keywords
- Chlamydia trachomatis, Chlamydia infections, Randomized controlled trials, Contact tracing, Family practice
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice nurse-led partner notificationBehavioural
Referral to specialist genitourinary clinicBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of index cases with at least one sexual partner treated
Number of sexual partners per index case treated
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2005 (estimated)
- Study startMar 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chlamydia InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Investigators
- Nicola Low, MFPH, Study director, Chlamydia Screening Studies (ClaSS) Project General Practices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112255
- Sponsor's protocol ID
- HTA_97/32/31
- Status last verified
- Jan 2018
- First submitted
- 31 May 2005
- Last updated
- 17 Jan 2018
- Results posted
- No
Publications
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.
PubMed 15459400Low 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.
PubMed 16356945
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partner Notification for Chlamydia in Primary Care: Randomised Controlled Trial and Economic Evaluation
- ClinicalTrials.gov ID
- NCT00112255
- Acronym / sponsor ID
- HTA_97/32/31
- Conditions
- Chlamydia Infections
- Keywords
- Chlamydia trachomatis, Chlamydia infections, Randomized controlled trials, Contact tracing, Family practice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- Dec 2002
- First posted
- 1 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Chlamydia trachomatis diagnosed through a population-based screening study
- Chlamydia test result received at patient's general practice
- Chlamydia cases diagnosed in general practice
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice nurse-led partner notification | Behavioural | – |
| Referral to specialist genitourinary clinic | Behavioural | – |
Primary outcome
Percentage of index cases with at least one sexual partner treated
Number of sexual partners per index case treated
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 15459400Low 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 publication: PubMed 16356945Low 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Low, MFPH study director
Chlamydia Screening Studies (ClaSS) Project General Practices
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Practice nurse-led partner notification and Referral to specialist genitourinary clinic in people with Chlamydia Infections, run by University of Bristol at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of index cases with at least one sexual partner treated. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112255, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.