Different approaches to partner notification in primary care | Not Recruiting
Different approaches to partner notification in primary care

Trial Source

Health Conditions
  • Sexually transmitted infections (STIs)
Not Recruiting
Recruitment Status
ISRCTN24160819
Primary Trial ID Number
Summary
Increasing numbers of patients are diagnosed with sexually transmitted infections (STIs) in their GP surgery. We want to find out the best way to arrange treatment for the sexual partners of individuals who are diagnosed with STIs in their GP practice (partner notification). Treatment of partners is important for two reasons; to protect the original patient from re-infection, and to prevent the further spread of infection. We will compare three different approaches: 1. Patient referral 2. Contract referral 3. Provider referral GP practices will be randomly split into three groups, and will manage all their patients according to ONE approach. We will measure how well these three approaches work, by comparing how many partners get treated and how many of the original patients are still infected in each group. In addition, we will do an economic study of the cost-effectiveness of each approach, and compare them. We are testing the following null hypothesis: Provider referral and contract referral offer no advantage over patient referral in partner notification for curable sexually transmitted infections in the primary care setting. More details can be found at: http://www.hta.ac.uk/1759
Primary Outcome Measures
  • 1. Number of main partners per index patient treated for chlamydia and/or gonorrhoea/nonspecific urethritis/pelvic inflammatory disease
  • 2. Proportion of index patients testing negative for the relevant STI at 3 months
Secondary Outcome Measures
  • 1. Number of partners per index patient presenting for treatment
  • 2. Proportion of index patients having at least one partner treated
  • 3. Number of main, casual and ex-partners per index patient tested for the relevant STI
  • 4. Number of main, casual and ex-partners testing positive for the relevant STI
  • 5. Number of index patients tested for HIV by 3 months
  • 6. Number of current partners tested for HIV by 3 months
  • 7. Time to definitive treatment of index patient for the relevant STI
  • 8. Time to definitive treatment of current partner for the relevant STI
  • 9. Uptake by index patients of "contract" and "provider" referral for one or more partners, within the relevant randomised groups
  • 10. Patient-related factors impacting on partner notification or STI disclosure to main, casual and ex-partners
  • An important secondary aim is to identify what patient-related or psychological factors impact on disclosure.
Research Question
  • Increasing numbers of patients are diagnosed with sexually transmitted infections (STIs) in their GP surgery. We want to find out the best way to arrange treatment for the sexual partners of individuals who are diagnosed with STIs in their GP practice (partner notification). Treatment of partners is important for two reasons; to protect the original patient from re-infection, and to prevent the further spread of infection. We will compare three different approaches: 1. Patient referral 2. Contract referral 3. Provider referral GP practices will be randomly split into three groups, and will manage all their patients according to ONE approach. We will measure how well these three approaches work, by comparing how many partners get treated and how many of the original patients are still infected in each group. In addition, we will do an economic study of the cost-effectiveness of each approach, and compare them. We are testing the following null hypothesis: Provider referral and contract referral offer no advantage over patient referral in partner notification for curable sexually transmitted infections in the primary care setting. More details can be found at: http://www.hta.ac.uk/1759
Design Type
Sorry, this information is not available
Ethics Approval
Brighton West Research Ethics Committee approved on the 14th October 2009 (ref: 09/H111/49)
Publications
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25619445
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
3300
Participant Inclusion Criteria
  • Practices:
  • 1. Practices from the MRC General Practice Research Framework (GPRF), the South East Primary Care Research Network (PCRN-SE) or the Primary Care Research Network Greater London (PCRN-GL)
  • 2. Registered populations of 5000 or more
  • 3. A maximum of six practices considering themselves as "student health centres" will be recruited, and no more than four regarding themselves as running "locally enhanced services for sexual health"
  • Individuals:
  • 1. Belonging to the target population above
  • 2. Over the age of 16 years (either sex) at the time of first attendance for this problem, or of screening for chlamydia (NB patients will be eligible if they refuse to communicate with partners, given the objectives of the study)
Participant Exclusion Criteria
  • Patients:
  • 1. Learning difficulties
  • 2. Unable to read trial materials after discussion with clinical staff
  • 3. No means of communication acceptable to the patient for him/herself
Interventions
We will compare three different interventions in partner treatment: 1. Patient referral: patients are given information about their infection, and asked to tell their partner about the problem and the need to be treated 2. Contract referral: in addition to point 1 above, patients will be asked to agree to a specialist health adviser (contact tracing expert) to inform partner(s) if this has not been done after an agreed period of time (usually two days) 3. Provider referral: in addition to point 1 above, patients will be asked to agree to a specialist health adviser contacting one or more of their partner(s) at the time of diagnosis Treatment is a communication process without a defined duration. Follow up will be 10 - 12 weeks.
Design Details
Sorry, this information is not available
Study Design
Interventional multicentre cluster randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
The relative clinical and cost-effectiveness of three contrasting approaches to partner notification for curable sexually transmitted infections (STIs): a cluster randomised trial in primary care
Secondary Trial Identifying Number
HTA 07/43/01
Website
Sorry, this information is not available
Study Funded By
NIHR Health Technology Assessment Programme - HTA (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Sussex (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 May 2010

Recruitment End Date

30 Apr 2013

Trial End Date

30 Apr 2013

Date added to Registry

18 Mar 2010

Last Updated

27 Jan 2015