Plain English Summary
Background and study aims
Rates of sexually transmitted infections (STIs) in the UK continue to rise each year. Successful control of STIs relies on reducing the spread of infection in the community. One way of doing this is to cut down the length of time an individual carries the infection before seeking treatment. Partner notification (PN) aims to do this by informing the infected person's sexual partners of the possibility of exposure, offering diagnosis and treatment, and providing advice about preventing future infection. However, the effectiveness of PN as it is currently practised in the UK is doubtful, and many sexual health/Genito Urinary Medicine (GUM) clinics struggle to reach national targets. We do not know the best ways of carrying out PN. The current system relies on the infected person informing their partners and advising them to attend a sexual health clinic or their GP for testing and treatment. This is known as patient referral. However, many sexual contacts are reluctant to come forward and new methods need to be tested. We believe that new methods of PN, which include assessment of the sexual partner by a healthcare professional but do not require clinic attendance, will be key to improving PN in the UK. We call these methods Accelerated Partner Therapy (APT). The aim of this study is to determine the acceptability and feasibility of two new models of APT for STI patients in UK clinics. We will also obtain evidence of the effectiveness of APT as compared with routine PN practice and find out for whom APT is best suited.
Who can participate?
Patients who are 16 and older and have tested positive for Chlamydia and/or Gonorrhoea (men and women), and men who have been diagnosed with non-gonococcal urethritis, and have at least one contactable partner.
What does the study involve?
Sexual health advisers in the participating clinics offer eligible patients a choice of three PN strategies:
1. APT Hotline (patient’s sex partner calls the APT hotline for a telephone consultation with a clinic health adviser/nurse practitioner)
2. APT Pharmacy (patient’s sex partner attends pharmacy for consultation)
3. Standard PN using patient referral (patient advises their sex partner to attend a sexual health clinic or their GP)
We then compare the outcomes for the APT interventions with standard PN. It is important to give the patient a choice because APT may be more effective if offered as part of a ‘menu’ of PN options, and so we can determine for whom APT is best suited. If APT is successful, it would also be offered as a choice alongside patient referral. Patients who test positive for Gonorrhoea are given antibiotics. Treatment packs include information sheets on the relevant antibiotics, including drug interactions and possible side effects. A study hotline number is also prominently displayed in each pack, which patients can use to obtain advice or support.
What are the possible benefits and risks of participating?
If the approach we propose is successful, it could enhance the provision of care to partners of patients with STIs, particularly those less likely to access existing services. The net result would be a decrease in STIs in the community and fewer re-infections. Together this would reduce the complications of STIs, such as infertility and pelvic inflammatory disease and their costly health consequences.
Where is the study run from?
Barts Sexual Health Centre in London and The Milne Centre in Bristol (UK).
When is the study starting and how long is it expected to run for?
November 2007 to July 2008
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Dr Lorna Sutcliffe (L.j.sutcliffe@qmul.ac.uk)
Dr Claudia Estcourt (c.s.estcourt@qmul.ac.uk)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lorna Sutcliffe
ORCID ID
Contact details
St Bartholomew's Hospital
Centre for Infectious Disease: Sexual Health & HIV
Barts & The London School of Medicine & Dentistry
Barts Sexual Health Centre
Kenton & Lucas Wing
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
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l.j.sutcliffe@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2564
Study information
Scientific title
Can Accelerated Partner Therapy (APT) improve outcomes of partner notification? A feasibility study and exploratory trial
Acronym
APT
Study hypothesis
We propose to develop two models of Accelerated partner Therapy (APT) and then to determine acceptability and feasibility of these two models of APT for index patients with chlamydia and/or gonorrhoea and/or non gonoccocal urethritis in the UK clinics and obtain preliminary data on effectiveness of APT as compared with routine PN.
Specific objectives:
1. To develop through qualitative research, consumer and stakeholder consultation, a feasible, replicable intervention for
delivering APT in UK GUM clinics
2. To determine the acceptability and feasibility of APT to clinic attenders, their sexual contacts and staff
3. To obtain preliminary evidence of effectiveness of APT compared with routine PN by undertaking an exploratory trial in two contrasting GUM services
4. To obtain cost data for APT strategies to use in preliminary economic evaluation based on restricted outcomes such as cost per partner treated
5. To develop a protocol for a formal randomised controlled trial (RCT) comparing the outcomes of APT with standard PN.
Interventions that involve changing health services are complex, so detailed development work is needed to define
appropriate study areas, study populations and potential interventions. This project comprises the first three stages of the UK Medical Research Council (MRC) Framework for Development of Randomised Controlled trials for Complex Interventions to Improve Health. The project will take place in two contrasting areas in England; Bristol, in the South West, which includes both rural and urban areas, and in inner city London.
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=2564
Ethics approval
East London Research Ethics Committee 1, 26/11/2010, ref: 06/Q0101/3
Study design
Non-randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Intervention
APT Hotline: Index diagnosed, treated & given APT PIN
1. Sex partner calls APT hotline for telephone consultation with clinic Health adviser/Nurse practitioner
2. Index takes or Sex partner collects APT Pack from clinic reception
3. Sex partner attends clinic for Human immunodeficiency virus (HIV) & test at later stage
4. Index & contact follow up call
APT Pharmacy, Index diagnosed, treated & given APT PIN
1. Sex partner attends pharmacy for consultation: trained pharmacist under Patient Group Directions (PGD) gives APT Pack
2. Sex partner attends clinic for HIV test at later stage
3. Index & contact follow up call
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Proportion of index patients having at least one partner treated 4-6 weeks after intial diagnosis
Secondary outcome measures
1. Proportion of regular partners treated
2. Number of contacts treated per index patient
Overall trial start date
01/11/2007
Overall trial end date
01/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Index patients who are 16 years and older
2. Have tested positive for Chlamydia and/or Gonorrhoea (men and women)
3. Men who have been diagnosed with non-gonococcal urethritis (NGU) and have at least one contactable partner
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 300; UK Sample Size: 300
Participant exclusion criteria
Will be determined by a suitabily qualified health professional are:
1. Pregnancy
2. Symptoms of complicated infection, allergy or contraindications to Azithromycin and or Cefixime
3. Inability to read English
4. An inability to understand instructions and give consent
5. Co-existent infection with syphilis and/or HIV as these cases require different investigation and management
Recruitment start date
01/11/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21795290