Different approaches to partner notification in primary care
| ISRCTN | ISRCTN24160819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24160819 |
| Protocol serial number | HTA 07/43/01 |
| Sponsor | University of Sussex (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 22/02/2010
- Registration date
- 18/03/2010
- Last edited
- 10/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Increasing numbers of patients are diagnosed with sexually transmitted infections (STIs) in their GP surgery. This study is concerned with finding out the best way to enable treatment for the sexual partners of individuals diagnosed with STIs in their GP practice. This is called "partner notification". Treatment of partners is important for two reasons - to protect the original patient from reinfection, and to prevent the further spread of infection by infected partner(s). We will compare three different approaches to partner treatment: patient referral, contract referral and provider referral. Patient referral is where patients are simply given information and asked to tell their partner about the problem and the need to be treated. Contract referral is where, in addition to patient referral, patients will be asked to agree to a specialist health adviser (contact tracing expert) to inform their partner(s) if this has not been done after a period of time (say, a week). Provider referral is where, in addition to patient referral, patients will be offered the option of a specialist health adviser contacting their partner(s) at the time of diagnosis.
Who can participate?
Patients over the age of 16 diagnosed with sexually transmitted infections at participating GP practices
What does the study involve?
Participating GP practices are randomly allocated into three groups, and trained to manage all their patients according to one of the above approaches. We measure how well these three approaches to partner notification work by comparing how many partners get treated. We also measure how many of the original patients are still infected in each group, as this is also a good measure of partner notification. We also compare the cost effectiveness of the three approaches.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Brighton and Sussex Medical School (UK)
When is the study starting and how long is it expected to run for?
May 2010 to April 2013
Who is funding the study?
Health Technology Assessment (UK)
Who is the main contact?
Prof. Jackie Cassell
j.cassell@bsms.ac.uk
Contact information
Scientific
Brighton and Sussex Medical School
Chair in Primary Care Epidemiology
Division of Primary Care and Public Health
Room 320, Mayfied House
University of Brighton
Brighton
BN1 9PU
United Kingdom
| Phone | +44 (0)1273 641924 |
|---|---|
| j.cassell@bsms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multicentre cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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.nets.nihr.ac.uk/projects/hta/074301 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51843/PRO-07-43-01.pdf |
| Ethics approval(s) | Brighton West Research Ethics Committee, 14/10/2009, ref: 09/H111/49 |
| Health condition(s) or problem(s) studied | Sexually transmitted infections (STIs) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Number of main partners per index patient treated for chlamydia and/or gonorrhoea/nonspecific urethritis/pelvic inflammatory disease |
| Key secondary outcome measure(s) |
1. Number of partners per index patient presenting for treatment |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 3300 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BN1 9PU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/05/2016: Plain English summary added.
