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.
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.
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.
