- What is the LUSTRUM programme?
- Which organisations are collaborating on LUSTRUM?
- Why conduct a Partner Notification (PN) trial?
- What is Accelerated Partner Therapy (APT)?
- What is the focus of Stream A?
- What is the focus of Stream B?
- What is the focus of Stream C?
- How many and which clinics will take part in the trial?
- How will clinics benefit from taking part in the trial?
- When will the APT trial start?
What is the LUSTRUM programme?
LUSTRUM is a five-year programme of mixed methods research led by Professor Claudia Estcourt, from Central & North West London NHS Trust and University College London and funded by the National Institute of Health Research (NIHR). LUSTRUM aims to improve the sexual health of heterosexual people and men who have sex with men (MSM). The programme aims to achieve this by preventing transmission of sexually transmitted infections (STIs) and reducing undiagnosed HIV.
The LUSTRUM programme is divided into three Streams:
- STREAM A - Partnership Typologies and RCT of Accelerated Partner Therapy (APT)
- STREAM B - Mathematical modelling of STI PN & HIV
- STREAM C - Development of PN interventions for MSM
LUSTRUM began in April 2016 and will end in March 2021.
For more information about the study methodologies please contact firstname.lastname@example.org
Which organisations are collaborating on LUSTRUM?
LUSTRUM is a collaborative programme of research led by Professor Claudia Estcourt, from Central & North West London NHS Trust and University College London. The research team is multidisciplinary, spanning clinical and academic sexual health & HIV medicine, health psychology, epidemiology, health services research, survey design expertise, public health, statistics, health economics, mathematical modelling, qualitative research, and data synthesis.
The following organisations are collaborating on this programme:
- Barts Health NHS Trust
- Brighton and Sussex Medical School
- Glasgow Caledonian University
- NHS Greater Glasgow & Clyde
- Public Health Scotland
- University of Bern
- University of Birmingham
- University College London
Why conduct a Partner Notification (PN) trial?
With some exceptions, many services involved in the 2012 BASHH National Audit struggled to reach BASHH standards for PN. Recent mathematical modeling work suggests that more effective PN could have a larger impact on population prevalence of chlamydia than increasing coverage of chlamydia screening (Althaus C et al 2012). However, the most effective means of achieving successful PN outcomes for bacterial STIs remains unclear. A recent Cochrane Review demonstrated that “enhancing” patient referral with written information, online resources, and/or patient delivered partner therapy was more effective than simple patient referral but there was insuffient data to recommend a single optimal strategy.
What is Accelerated Partner Therapy (APT)?
APT refers to PN strategies which reduce the time for sex partners to be treated and include assessment by an appropriately qualified health care professional (Estcourt CS et al 2012). APT is acceptable to patients (Sutcliffe L et al 2009) and is aimed at asymptomatic / minimally symptomatic sex partners and can include a urine/ vulvo-vaginal swab sampling kit to facilitate a second round of PN as appropriate. Research to date has made use of telephone assessment of sex partners by health advisers (APTHotline) and community pharmacists assessing sex partners under PGD within their pharmacies (APTPharmacy) (Estcourt CS et al 2012, Roberts TE et al 2012). Our proof of concept study, based in sexual health clinics, suggests that APT results in a higher proportion of sex partners treated than routine PN and importantly that those partners receive treatment more quickly than those receiving routine PN (Estcourt CS et al 2012, Roberts TE et al 2012). We are currently analysing data from our randomised controlled trial of APT for women diagnosed with chlamydia in community settings in England (Estcourt CS et al 2012, NIHR CRC portfolio10123). Very recently, extensive modeling work has shown that reducing time to treatment is particularly important in reducing re-infection (Low N et al 2014) and there has been voceiferous support for more research into APT in the context of a full scale trial (Low N et al 2014; Althaus C et al 2014).
What is the focus of Stream A?
Stream A focuses on exploring partnership typologies, optimising the intervention and conducting a cross-over cluster randomised trial of APT.
Stream A starts with Phase 1, a collection of brief preliminary studies underpinning the partnership typology; required for outcome measurement in the programme. It will deliver an evidence grounded consensus on clinically usable and measurable partnership types. This will underpin sub-group analysis within the RCT, the mathematical modelling of Stream B and the intervention development in Stream C.
Using the MRC framework for development of complex interventions we will build on our previous exploratory and pilot APT studies. Here, we will further refine the APT intervention within a new theoretical framework, grounded in health psychology to optimise the APT intervention for our chosen settings and patient groups. We will also draw on expedited partner therapy (EPT), the intervention from which APT was derived to be compliant with UK prescribing guidance.
During Phase 2, we will maximise the acceptability of the APT intervention to target groups and the health professionals involved with PN; refine our APT web-tool, and pilot the partnership typology from Phase 1 in clinical settings (see above).
During Phase 3, we will conduct a cross-over randomised controlled trial, clustered by clinic, of one APT intervention (health adviser led immediate telephone APT) compared with standard PN (enhanced patient referral). To complement the trial findings, we will develop a dynamic model of the epidemiology of C. trachomatis transmission, the APT intervention and its outcomes.
For information about Stream A, please contact email@example.com.
What is the focus of Stream B?
Stream B will explore whether improved PN for bacterial STIs in MSM can effect a reduction in undiagnosed HIV.
This work stream will use literature reviews, evidence synthesis and mathematical modelling to gain insights into events that empirical studies cannot observe directly.
Specifically, we will:
- develop dynamic transmission models that describe STI/HIV co-infection in MSM;
- determine the probabilities that the sexual partners of MSM with a bacterial STI are HIV infected and can be accessed by PN;
- determine the impact of improved PN and the groups of MSM that are most important to reach through STI diagnosis and PN so that Stream 4 can develop appropriate interventions.
What is the focus of Stream C?
Stream C focuses on the development of optimal PN interventions for MSM for bacterial STIs and HIV.
Capitalising on Streams A and B, and primary research, Stream C will specify an optimal PN intervention for MSM with acute bacterial STIs and HIV. We will undertake a suite of inter-related studies to propose an optimal PN intervention for MSM. Phase 1 details economic evidence synthesis concerning existing economic studies about PN and/or testing and treatment for STIs/HIV. Phase 2 details sequential mixed-method exploratory primary research concerning PN in general. This will involve retrospective semi-structured, one-to-one, interviews which focus on experiences of previous PN pathways, the inhibiting/facilitatory role of MSM sexual cultures in relation to PN, and culturally sensitive approaches to PN. A complementary quantitative study will examine the distribution and/or experience, acceptability and feasibility of PN approaches to STIs and HIV amongst MSM.
We will then synthesise and integrate all findings relating to APT and its likely implementation amongst MSM. A matrix of emergent findings from Stream A and B will be developed in order to manualise an optimised, culturally appropriate, tailored candidate APT intervention for MSM, exploiting the existing trial sites and associated staff expertise with APT (heterosexuals), and research methods.
How many and which clinics will take part in the trial?
Fourteen clinics (or clinical services) will be chosen to take part in the trial. Clinics will be randomised between initial intervention or control status before the trial begins, by random permutation and stratified by clinic type. We anticipate two strata, urban and rural, to reflect types of service configuration, and access to services.
Clinical championing is key to the success of this type of public health / health service research; potential clincial trial sites need to demosntarte that they are fully on board and commited to the trial of the APT intervention. Enthusiam will be far more important than research experience and we encourage any interested clinics to contact us using this form or via email.
How will clinics benefit from taking part in the trial?
LUSTRUM is a prestigious research trial. Participating will advance knowledge on new methods of PN and provide patients with new PN opportunities. We will of course provide necessary additional funding to allow for research data collection, time spent on the study over and above that which you would spend in routine care. The service will be acknowledged in all publications and presentations. We will ask participating clinics to nominate one clinician (from any health care discipline) as the trial lead and he/she will be a named author subject to appropriate contribution to the research and writing process.