Can Expedited Partner Therapy Improve Outcomes of Partner Notification? A Feasibility Study and Exploratory Trial

Lead Research Organisation: Queen Mary, University of London
Department Name: Unlisted

Abstract

Rates of sexually transmitted infections (STIs) in the UK continue to rise each year. Reported infections with chlamydia, a bacterial infection which is often present without any symptoms and can lead to infertility and chronic pelvic pain, have increased by 139% since 1996. Successful control of STIs relies on reducing 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 in controlling STIs, as currently practised in the UK, is doubtful and many sexual health (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. Many sexual contacts are reluctant to come forward and new methods need to be tested. In the USA ?Expedited partner therapy? (ExPT), strategies which reduce the time taken for sexual partners to be treated, are becoming increasingly established, but these have never been evaluated in the UK. A key part of these new methods is patient delivered therapy, in which the patient is given additional antibiotics to give to their partner(s). This means that their partners do not necessarily need to attend clinic. Some studies have already shown that UK patients would find this option highly acceptable.

Our study will use patient, GUM clinic staff and community groups to develop two models of expedited partner therapy to test in two GUM clinics in the UK. We will obtain preliminary evidence of the effectiveness of ExPT as compared with routine partner notification practice and find out for whom ExPT is best suited. We will also determine costs associated with the ExPT strategies. If the approach we propose is successful, it could enhance provision of care to partners of individuals with STIs, particularly those less likely to access existing services, and thus reduce sexual health inequalities. The net result would be a decrease in STIs in the community and fewer re-infections. Together this would reduce complications of STIs, such as infertility and pelvic inflammatory disease and their costly health consequences.

Technical Summary

The effectiveness of partner notification (PN) in controlling STIs in the UK is doubtful. GUM clinics struggle to reach national standards, whilst reported cases of bacterial STIs continue to increase. ?Expedited partner therapy?, which aims to reduce time to treatment for sexual partners and includes patient delivered therapy, is becoming increasingly established in USA. In the UK, despite evidence that clinic users find ExPT desirable, patient referral is the mainstay of PN. We propose to determine acceptability and feasibility of two models of ExPT for index patients with C.trachomatis and/or non gonoccocal urethritis in UK clinics and obtain preliminary data on effectiveness of ExPT as compared with routine PN.
Specific objectives:
1. to develop through qualitative research, consumer and stakeholder consultation, a feasible, replicable intervention for delivering ExPT in UK GUM clinics
2. to determine the acceptability and feasibility of ExPT to clinic attenders, their sexual contacts and staff
3. to obtain preliminary evidence of effectiveness of ExPT compared with routine PN by undertaking an exploratory trial in two contrasting GUM services
4. to obtain cost data for ExPT 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 RCT comparing the outcomes of ExPT with standard PN.
Study design: feasibility study followed by an exploratory trial.
The feasibility study will analyse qualitative interviews with clinic users to develop candidate models for ExPT and assess acceptability of components of the models through focus groups with clinic users, community group representatives, and professional standards organisations and clinic staff to finalise two candidate models for evaluation.
In an exploratory trial we will undertake enhanced clinic data collection for PN during a baseline period of standard PN. During a four month intervention phase, health advisers in two clinics will offer eligible patients choice of two ExPT models or standard PN. We will recruit 200 patients and their partners into the study. We will undertake baseline clinical attitudinal and preference assessment and follow up participants by telephone six weeks after diagnosis to determine acceptability, process and PN outcomes and access data from the clinic PN database.
The primary quantitative outcome measure for the exploratory trial is the proportion of index patients having at least one partner treated six weeks after the initial diagnosis.
We will compare outcomes from participants choosing ExPT with those choosing standard PN.

Publications

10 25 50
 
Description All Party Parliamentary Group
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description BASHH Public Health debate
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description HPA National conference: Partner notification session
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description NCSP National working group presentation
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description NCSP Partner Notification for Chlamydia in Community Settings. Recommendations on process and outcome standards in English practice.
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in other policy documents
Impact As above - I am involved in on going discussions in an advisory capacity,
 
Description The National Collaborating Centre for Infectious Diseases (NCCID) Canada
Geographic Reach North America 
Policy Influence Type Participation in a national consultation
Impact Consultation with all Public health leads on partner notification within Canada's territories.
 
Description Program Grants for applied research RP-PG-0707-10208 The Men's Sexual health UK (MESHUK) Program: improving the sexual health of men in the UK
Amount £2,000,000 (GBP)
Funding ID RP-PG-0707-10208 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2009 
End 01/2015
 
Title APT PN Models 
Description We developed 2 novel partner notification interventions known as Accelerated partner Therapy ( APT) 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2010 
Provided To Others? Yes  
Impact APT models are now being evaluated in primary care. 
 
Title APT Partner Notification database 
Description Dtabase for collection of partner notification data from indexes and contacts 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact We will base our new APT webtool for primary care (funded by NIHR program grant) on this database. 
 
Description HTA Partner Notification in Primary Care Trial 
Organisation University of Sussex
Department Brighton and Sussex Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution Significant intellectual input
Impact Three poster presentations at National and International conferences
Start Year 2010
 
Description National Chlamydia Screening Programme 
Organisation Public Health England
Department National Chlamydia Screening Programme NCSP
Country United Kingdom 
Sector Public 
PI Contribution Contibuted to NCSP consultation document: Partner Notification for Chlamydia in Community Settings. Recommendations on process and outcome standards in English practice. Document explicitly states that outcome of APT trial may influence their final recommendations. Invitated speaker NCSP National Conference November 2009, to present trial data
Collaborator Contribution The Director of NCSP is a collaborator on our APT RCT in primary care (NIHR funded). This came about as a direct result of her interest in the MRC funded APT trial.
Impact NCSP consultation document: Partner Notification for Chlamydia in Community Settings. Recommendations on process and outcome standards in English practice.
Start Year 2007
 
Description eSTI2 
Organisation St George's University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution lead for developing regulatory pathways for novel diagnostic & clinical pathways for remote STI testing & treatment
Impact project starts 1.2.2011
Start Year 2010
 
Description Primary Care Trusts 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Policymakers/politicians
Results and Impact Presented our results to 3 Primary Care Trusts and other genitourinary medicine (GUM) clinics interested in Accelerated Partner Therapy. Between 5-30 attended at each meeting.

Each Primary Care trust has expressed an interest in working with us in our subsequent study of Accelerated Partner Therapy in Primary Care. The GUM clinics are using our knowledge and experience gained in setting up and running the APT exploratory trial.
Year(s) Of Engagement Activity 2009