Improving sexual health through partner notification: the LUSTRUM mixed-methods research Programme including RCT of accelerated partner therapy

Qualitative studies–developing a classification of sex partner types

Accelerated partner therapy barriers and facilitators and optimising accelerated partner therapy

Background

APT is a PN method whereby during the IP’s clinic attendance, HCPs assess SPs by telephone consultation, before sending out or giving the IP antibiotics and STI and HIV self-sampling kits to deliver to their SP(s). APT has shown promise in pilot trials. 20,21

Aim and objectives

Aim: to determine the effectiveness of APT in improving outcomes of PN for genital chlamydia in heterosexuals in a cluster crossover RCT.

Specific objectives are to determine:

1. The effect of APT on the proportion of IPs who test positive for chlamydia 12–16 weeks after the PN consultation (the gold standard outcome in PN trials).

2. The effect of APT on the proportion of SPs treated.

3. The effects of APT according to SP type.

4. The effect of APT on the proportion of SPs notified.

5. Whether APT is associated with faster treatment than standard PN.

Methods for data collection and analysis

Trial design: a cluster crossover RCT of APT offered as an additional PN method compared with standard PN alone. 9 The APT intervention was offered at the level of the sexual health clinic, with randomisation of each clinic to either intervention or control arm in the first phase of the trial.

The trial was accompanied by an economic evaluation, transmission dynamic modelling and a qualitative process evaluation.

Clusters were 17 sexual health clinics (publicly funded) in areas of Britain with contrasting patient demographics.

Participants were heterosexual women and men, aged ≥ 16 years with a positive test for C. trachomatis and/or clinical diagnosis of pelvic inflammatory disease (PID) or cervicitis (women) or non-gonococcal urethritis (NGU) or epididymo-orchitis (men) and reporting at least one contactable sexual partner in the past 6 months.

Recruitment: during the initial PN consultation with the IP, the HCP assessed eligibility for the study. As this was a low-risk health intervention, consent was provided at service level.

Intervention: APT offered as an additional PN method compared with standard PN alone (see the APT overview film22). The APT intervention was offered at the level of the sexual health clinic, with randomisation of each clinic to either intervention or control arm in the first phase of the trial (random permutation). Figure 2 shows an overview of the APT process.

FIGURE 2.

Diagram showing the steps of the APT process.

Control: standard PN, which was enhanced patient referral in which HCPs asked the IP to inform their SP(s) of the need for testing and treatment, supplemented by written or website information.

Trial periods: there was a 4-month run-in period (July–October 2018), consisting of rolling clinic set-up including training for HCPs and a period of at least 2 weeks of baseline data collection when HCPs used RELAY to record standard PN data. Then nine clinics entered intervention phase while eight entered control phase, according to the randomisation schedule. At the end of the first 6-month trial phase (November 2018 to April 2019), there was a 2-week washout period where clinics did not offer APT to patients and followed their standard PN procedures. Then clinics crossed over to the opposite arm (intervention or control) for phase two (for 6 months, May–November 2019). The total duration of the trial was 19 months, allowing for a 3-month follow-up period to enable outcome data collection to be completed for all patients in the second trial phase. Clinics which did not start phase one of the trial in November 2018 completed recruitment in November 2019 and trial phases were condensed.

The primary outcome was the proportion of IPs testing positive for C. trachomatis 12–24 weeks after the PN consultation. Secondary outcomes included the proportion of SPs treated; the proportion of SPs notified; cost effectiveness; model-predicted chlamydia prevalence; SP and HCP experiences of APT.

The primary outcome analysis was by intention to treat, fitting random-effects logistic regression models that account for clustering of IPs within clinics and trial periods. The statistician carried out analysis of the primary outcome blinded to allocation.

Trial registration: This trial is registered as ISRCTN 15996256.

Development of APT web tool: we adopted a user-centred approach to further develop the functionality and design of RELAY created and refined in previous studies. 20,21 Clinic HCPs entered clinical data and any data collected for research purposes directly onto RELAY during the PN consultation. RELAY supported the APT patient pathway, enabling rapid communication between the clinics and the supporting RHAs. A new function enabled a clinical summary to be downloaded and incorporated into the patients’ clinic electronic patient records.

We undertook an extensive pre-design (product testing) phase and rounds of iterative development with health professionals and sexual health clinic health advisers to ensure that the tool met their needs, current activity, and work habits.

We also ‘stress tested’ RELAY and performed a dummy data retrieval exercise, in which an independent company comprehensively tested the system for errors and its ability to extract all relevant data variables needed for the statistical analysis plan for the trial.

RELAY had been developed to exceed all contemporary NHS data storage and transfer standards and NHS information governance compliance with strict adherence to the Caldicott principles of confidentiality, as outlined in the Caldicott report 1997. 23 However, the process for research and development (R&D) and Information Governance approval in several of our trial sites was extremely arduous, created substantial delays in some cases and almost prevented participation in one site.

Ethical approval and the General Data Protection Regulation paradox: Ethical approval for the trial was provided by London – Chelsea Research Ethics Committee (18/LO/0773) and approved us to seek consent for trial participation from lead clinicians at participating clinics (service-level) rather than seeking individual informed consent from IPs other than for the process evaluation studies. Following Weijer et al. ,24 we believed that APT is a complex, ‘low-risk’ healthcare delivery intervention. APT is offered in addition to standard PN and operationalised as a supplement to usual care; thus, IPs have the choice of taking up APT or not. It is widely accepted that individual consent may not be essential in such trials,25 in which the situation is analogous to the introduction of changed processes in routine services. 26 This was important for the RCT as individual-level consent is thought to have contributed to low recruitment numbers in a previous study of APT. 21

However, the newly introduced General Data Protection Regulations (GDPR) required that individuals have the option to choose whether their data may be used for research. This presents a challenge when consent has been given by the clinical service and not by individual service users. We developed a pragmatic opt-out solution to this consent paradox. 27 Our approach supported the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients.

Selection of clinics: we selected 17 NHS (publicly funded, free to access) specialist sexual health clinics (clusters) across England and Scotland from those expressing interest. Selection was based on numbers of reported chlamydia diagnoses data in the Public Health England Genitourinary Medicine Clinical Activity Dataset for STI surveillance28 (England) and geographical diversity (Scotland) to create three strata: London, non-London metropolitan ‘cities’ and non-London urban ‘towns’. A full list of study sites is included in the published study protocol. 9

Training of clinic staff and site set-up and support: multidisciplinary members of the trial team (researchers, research heath advisers and clinicians) made a study initiation visit to each clinic prior to randomisation to train staff in intervention delivery, the use of RELAY and the novel classification of SP types needed for data collection. The training consisted of (1) a whole clinic presentation explaining an overview of the trial, (2) small group interactive APT training using observed and participatory role plays and use of the intervention manual, (3) training and quizzes on use of the new partner type classification and (4) one-to-one or small group training in use of RELAY.

In addition, we created a series of training videos which enabled those who were unable to attend, new staff who joined during the study period, staff from clinics which entered intervention phase second to learn/refresh their skills and knowledge. We have subsequently made all resources available on our website and YouTube channel.

The trial team liaised with and supported clinics extensively. Typically, this included a weekly telephone call with each site lead, refresher training either on site or remotely when clinics switched from control phase to intervention phase and ad hoc as requested by the clinics or if recruitment appeared to slow.

Stable data collection: we introduced RELAY into each clinic 1 month before the start of the trial. Clinic health advisers used RELAY as their routine method of recording PN consultations and outcomes of existing methods of PN and clinical data on SPs using the new SP classification.

Limitations

Overall enrolment and follow-up were lower than expected20,21 and statistical power was lower than assumed. APT uptake itself was not a part of the power calculations, but we expected more IPs to choose it. We were unable to determine whether APT was associated with faster treatment because only small number of IPs knew when, as opposed to whether, their SPs had been treated.

The pragmatic trial design was intended to ensure that the effectiveness of APT would be evaluated under real-life clinical conditions. However, trial procedures meant that APT required additional data collection regardless of whether the patient accepted the APT intervention. This, together with wider operational factors (see Stream A phase 3: process evaluation), meant that it was seldom offered routinely. 29

Key findings

Figure 3 provides an overview of the trial.

FIGURE 3.

Flow diagram of enrolment by clinic randomisation status and period. a, Administrative service data on all chlamydia diagnoses within trial period in non-MSM patients aged ≥ 16 years not attending as PN contact; b, All potentially eligible SPs treated prior to clinic consultation of IP.

All clinics completed both periods. One thousand five hundred and thirty-six and 1724 IPs provided data in intervention and control phases. In intervention and control phases, 666 (43.4%) and 800 (46.4%) IPs were tested for C. trachomatis; 31 (4.7%) and 53 (6.6%) were positive, adjusted odds ratio (aOR) 0.66 [95% confidence interval (CI) 0.41 to 1.04; p = 0.07]. In total, 4807 SPs were reported, of whom 1636 (34.0%) were committed/established partners. Characteristics of index cases and partners were balanced. Overall, 293/1536 (19.1%) of IPs chose APT for a total of 305 partners, of whom 248 accepted. The proportion of IPs with one or more SPs notified was 1123/1150 (97.7%) in the intervention phase and 1185/1218 (97.3%) in the control phase (aOR 1.18, 95% CI 0.70 to 2.00; p = 0.54), while the proportion of all partners notified was 95% in both phases (aOR 0.80, 95% CI 0.49 to 1.29; p = 0.35). The proportion with ≥ 1 SP treated was 775/881 (88.0%) in intervention and 760/898 (84.6%) in the control phase, aOR 1.27 (95% CI 0.96 to 1.68; p = 0.10).

One thousand five hundred and thirty-six IPs with 2218 partners were enrolled in APT intervention phases, but APT could not be offered by the clinic in 81/2218 of these. The IP selected APT for 305/2137 (14.3%) partners when available. Of these, 166/305 (54.4%) were committed/established, 85/305 (27.9%) were new, 45/305 (14.8%) were occasional and 9/305 (3.0%) were one-off partners. Common index reasons for declining APT included: preference for face-to-face conversation 400/1832 (21.8%), partner already in clinic 388/1832 (21.2%), unwilling to engage with partner 206/1832 (11.2%), preferring partner to attend clinic 202/1832 (11.0%), partner overseas 150/1832 (8.2%). Of 241 partners sent APT packs, 120/241 (49.8%) returned chlamydia and gonorrhoea testing samples, of which 78/119 (65.5%) were positive for chlamydia (no result obtained for one returned sample), but only 60/241 (24.9%) HIV and syphilis samples (all negative). Of 106 IPs offered APT, which was accepted ≥ 1 partners, and tested for chlamydia at 12–24 weeks, only 2 (1.9%) were positive. This contrasts with 6.6% (53/800) in the control arm and 5.2% (29/560) in IPs not selecting APT or whose partners refused. There were seven adverse events reported (see Report Supplementary Material 1), all deemed to be of low severity and managed through discussion with the Trial Steering Group and Trial Management Group.

Tables 1–8 show the trial data and outcomes.

Conclusions

APT is a safe, feasible and effective way of clinically managing SPs of people with chlamydia as part of a menu of contact tracing and management options. While APT uptake was low among patients assessed for eligibility, it was associated with a small reduction in chlamydia positivity in IPs at 4 months and a higher number of partners treated. In almost all instances where APT was accepted, this was for established/committed relationships, while one-off partnerships made up only 1 in 30 APT decisions, although these amounted to 1 in 5 partnerships in the intervention period.

More work is needed to increase engagement of the SPs with self-sampling for STIs including syphilis and HIV so that opportunities for screening are not lost. The trial was not powered to evaluate differences in APT uptake according to ethnicity or age, but data from the trial indicate that this may be lower in ethnic minority groups.

Accelerated partner therapy processes could be adapted for use in other groups such as MSM, trans and transgender people, but they are only feasible for infections routinely treated by oral medication. The first-line therapies for both gonorrhoea and syphilis are currently parenteral in many countries. 30 More broadly, we need to consider the partners who will not be reached by APT (one-off partners with whom future sex is not anticipated). Although not a risk to the IP, they are likely to make an important contribution to community transmission. New interventions are needed to directly target this group.

Interrelation with other parts of the Programme

Earlier intervention optimisation and associated studies provided the trial with a new classification of SP types used in collection of outcome data, an optimised APT intervention within a fully manualised intervention and HCP training package, RELAY, a bespoke data collection and clinical management webtool, to manage IPs and SPs during the trial. Trial data informed the health economics evaluation and the mathematical model (Stream B). New knowledge gained from the prospective logic model and its retrospective application to assist interpretation of trial and Programme findings caused us to move away from basing our novel PN intervention for MSM with one-off sexual partners on APT. The finding that APT appealed to people in relationships with a greater degree of emotional connection but much less so within one-off or short duration partnerships paved the way for a different approach in Stream C.

Aim and objectives

To conduct a qualitative process evaluation to understand IPs’, SPs’ and HCPs’ experiences of APT, the trial and its key contexts.

Specific objectives were:

• to use programme theory to detail assumptions and expectations about how APT would work within SHSs and the wider context before data collection and analysis

• to use qualitative analyses from multiple stakeholders to explore the relative role of the context, issues of intervention fidelity and the actual contribution of varied putative intervention mechanisms in shaping intervention outcomes, both intended and unintended.

Limitations

Limitations relate to the inherent biases within the sampling (e.g. self-selected). Furthermore, if we had been able to collect data within both trial arms (rather than via single retrospective recall), it may have been possible to delineate trial burden from intervention more clearly.

Key findings

We developed initial programme theory and an accompanying logic model to describe how APT was imagined to work and we detailed various intervention mechanisms using behavioural and implementation science. 29 Preliminary work showed that APT was anticipated to primarily change key interactions and SHS organisation to accommodate accelerated and safe remote care to lead to reductions in IP reinfection. We theorised these mechanisms at various levels, drawing on behaviour change perspectives, implementation science and systems perspectives.

Subsequently, using the deductive thematic analysis, we used programme theory to create an evidence-based, theoretically informed overview of how APT worked dynamically within the context of the trial and within British SHSs. This is visualised in the colour-coded overview logic model (see Figure 4). We found APT training and resources (especially RELAY) transformed key interactions as anticipated. Overall intervention fidelity was good, and APT was well-liked by those who delivered and received it. Equally putative intervention mechanisms worked mostly as expected, although those concerned with local implementation sometimes worked counter to expectations because of contextual interdependencies. The trial struggled to be implemented at scale across all sites. Considerable external pressures drove all services to constantly adapt to achieve efficiencies. In some services, APT was perceived as time-consuming and without palpable impact. This seemed to be because APT did not visibly reduce patients ‘in the waiting room’. As such, the ‘invisibility’ of the effectiveness of APT curtailed the establishment of positive feedback loops driving normalisation within services.

FIGURE 4.

An overview of findings from the qualitative process evaluation shown through a colour-coded logic model of APT.

Text in light blue shows where our initial programme theory was supported through process evaluation data. Text in dark blue shows mixed findings in relation to supporting our initial programme theory. Text in red shows where our initial programme theory was not supported through process evaluation data.

Index patients and SPs who used APT primarily did so within established relationships. APT was particularly beneficial when one partner experienced barriers to attending face-to-face sexual health care (such as STI stigma, work constraints). Despite including a consultation with an appropriate HCP, APT necessitates a shift in responsibilities away from staff within services and onto patients and their partners. This worked well for some who felt more empowered and in control of their care, but others struggled with the burden of information and new processes. For example, some SPs took the treatment immediately but waited until treatment was completed to use the self-sampling kits as a ‘test of cure’ and others reported difficulties in doing finger-prick blood sampling. There was also confusion about the rationale for testing for STIs other than chlamydia despite provision of verbal and written explanations. The intended support to mitigate some of these aspects of APT was disrupted by NHS data communication constraints, which prevented HCPs from sending direct links to short YouTube videos we had created to assist engagement with APT processes. Overall, we found a mixed picture of a well-liked, intuitive, coherent intervention struggling to gain traction within already pressured services.

Interrelation with other parts of the Programme

These analyses helped us understand and contextualise the RCT findings and were informative for the intervention development work with MSM (Stream C). Notably, findings illustrated the key pressures that SHSs were experiencing at the time of the RCT and the apparent systemic deprioritisation of PN activities. As a result, this led to the team reconsidering their approach to intervention development with MSM and the decision to avoid an intervention which relied upon the work and activities of SHSs alone. Drawing upon concepts from systems science, we decided to conceptualise a future PN intervention for MSM in a more distributed way, including the activities of wider stakeholders such as MSM themselves, community-based organisations and those who provide dating apps/dating sites to facilitate sexual mixing. In this way, with a range of agents distributed across the system driving poor PN amongst MSM, it was feasible to avoid intervention components which risked placing undue burden on SHSs.

Background

Economic evaluations are typically conducted to inform decisions on the best intervention among a given set of alternatives. 31 Most infections are asymptomatic leading to a delay in detection and treatment and onward transmission. Untreated chlamydia can cause reproductive health complications. 32 Chlamydia imposes a considerable economic burden on healthcare systems mostly attributed to complications of non-treatment and re-infections. 33 In Britain, the economic burden of chlamydia to the NHS is approximately £100 million per annum. 33

We conducted a cost-consequence analysis (CCA) alongside the trial. We considered a CCA as an appropriate method because the predetermined trial outcome of ‘cases of reinfection avoided for the index patient’ is deemed as an intermediate outcome for health economics since the full impact of infection, for both the individual and the population, given the infectious nature of the disease, cannot be fully assessed based on this outcome. The longer-term impact and the related cost effectiveness of the APT intervention are evaluated using appropriate methods34 as part of the LUSTRUM Programme and are reported elsewhere.

Aim and objectives

To compare the costs and outcomes of APT versus standard PN for avoiding reinfections in IPs with chlamydia.

Methods for data collection and analysis

The CCA adopted the perspective of the NHS; hence, only direct healthcare costs were considered. We collected data on costs and resource use prospectively during the trial – from the initial consultation up until 24 weeks post intervention. We drew unit costs primarily from the trial and the Personal Social Services Research Unit (PSSRU) costs35 and we applied weighted averages to these costs where appropriate. All costs were reported in 2019–20 British pounds. We inflated Sterling values and cost estimates from previous years using the NHS cost Inflation Index (NHSCII). 35

Resource use data were recorded on RELAY by various cadres of HCPs. The key categories of resource use data for the IPs were:

1. Initial consultations: this included data on HCPs’ pay grade (bands) and the length of the consultation. A precise measurement of the initial consultation duration within the trial was not feasible; hence, assumptions were made based on clinical advice and estimates from a convenience sample of the trial HCPs. All estimates included time for trial-related tasks but did not include any telephone consultations with the SPs.

2. Two week follow-up calls: to determine IP reported PN outcomes, follow-up calls were made 2 weeks after initial consultations by two RHAs. Cost estimates included the average wage/hour 6 length of call and additional time for administrative tasks.

3. Retesting: to provide the primary outcome, IPs were retested for chlamydia at 12–24 weeks. This was either self-testing (using a self-sampling kit posted to them) or testing in the clinic. The costs of the retest pack were obtained from the trial. For retest in a clinic, we assumed standard practice for staff band and test duration. 36

4. Text message: we used text messaging service costs for a large London hospital trust as a proxy. 37

The key categories of resource use data for the SPs who accepted APT were:

1. Telephone Consultation: trial data provided the average duration of a telephone consultation. The cost of a phone call was sourced from a National UK telephone Company (BT). In estimating costs, additional time used by the HCP for patient-related administrative work was included.

2. The content of APT packs: we estimated the costs of the APT packs based on information collected during the trial. A breakdown of these costs is provided.

For SPs during the control phase, we sought data on the number of contactable SPs, clinic attendance for consultations and tests, and test outcome when available and made assumptions if data were not available.

A CCA is typically the first step in an economic evaluation in which costs and outcomes are assessed in a disaggregated manner to see if any intervention shows clear dominance. The result of the CCA analysis is presented as the total costs for PN. We conducted a further analysis of the SPs. We did not apply discounting to either the costs or outcomes due to the short duration of the trial. The reporting is in line with the consolidated health economic evaluation reporting standards (CHEERS) statement. 38 We performed statistical analyses using STATA 15.0^®39 or Excel Spreadsheet.

We conducted one-way deterministic sensitivity analyses (see Appendix, Table 11) to assess the impact of changes to the base-case assumptions and included variations in:

1. pay band/grade of the staff for the initial consultation

2. duration of the initial consultation

3. follow-up calls.

Limitations

The CCA benefited from the robustness of the main analyses as shown by the sensitivity analyses. We were unable to use data from RELAY on the duration of initial consultations due to wide variations in data quality between sites. However, we made assumptions based on trial evidence and hence were able to conduct analyses with practical values.

A CCA provides a breakdown of costs and outcomes only – it can sometimes be used to inform decision-making, if the decision-maker can make judgements on the ranges of cost and outcome presented. 40,41 However, in this case, we caution against any such interpretation.

This is because the CCA is based on an intermediate outcome only, and the full impact of the intervention on the transmission of the STIs across the population and its impact on sequelae associated with the disease can only be assessed by modelling the impact on the transmission flow using a transmission dynamic model. 33,34

Key findings

We estimated the costs and outcomes of APT versus standard PN in avoiding reinfection based on negative tests at trial end. The primary outcome was available for 809 IPs in the control phase and 671 IPs in the intervention phase inclusive of 125 patients that selected APT for their SPs. Amongst these, 747 (92%) patients in the control phase and 513 (94%) patients without APT and 122 (98%) (with APT) in the intervention phase had a negative test result, an indication that re-infection was avoided. The total costs of PN for the IPs were estimated as £71.26 for the control phase, and as £91.23 and £74.83 for the intervention phase, with and without APT, respectively. The total cost of PN was £33.17 for SPs who utilised APT and £39.58 for the SPs in the control phase. The sensitivity analyses showed that for all scenarios explored, the results made no substantial difference to the base-case results.

The CCA provides preliminary results only, hence at this stage, no judgement can be made on the cost effectiveness of the intervention. The outcome (reinfections avoided) is an intermediate outcome since it is impossible to know how the outcome would impact on the final outcome and the ultimate sequelae caused by the infection.

The preliminary results show that the APT intervention was more costly than the standard PN (£91.23 vs. £75.21). The intervention with APT accepted avoided re-infections in 98% of patients, compared with 92% for standard PN. The findings suggest that APT could provide an effective addition to the current standard PN practice in Britain.

Interrelation with other parts of the Programme

The findings of the economic evaluation will provide costs and resource use input for the health economic analysis of Stream B which will evaluate the long-term effects of APT versus standard PN.

Aim and objectives

While the direct effects of standard PN and APT on the identification of new chlamydia infections are well-documented42 and can be observed in the RCT, the indirect population-level effects on incidence and prevalence of chlamydia are less clear. 43 In order to better understand and interpret the outcomes of the RCT, we estimated the expected proportions of chlamydia positivity in partners of people with diagnosed chlamydia (index cases) and quantified the effects of APT on chlamydia prevalence compared with standard PN in Britain.

Methods for data collection and analysis

We developed a novel deterministic, population-based chlamydia transmission model (see Figure 5). 44 A dedicated PN module allowed us to track the most recent partners of index cases and to identify the index–partner combinations that result in the largest effect of PN on reducing chlamydia prevalence. We considered a population aged 16–34 years and calibrated the model to sexual behaviour data between people of the opposite sex and chlamydia prevalence data reported by 3671 participants in Britain’s third (Natsal-3, 2010–12)3,45 using approximate Bayesian computation (ABC). In different scenarios, we calibrated the model to sex- and activity group-specific prevalence in the presence (current situation) and absence of control interventions. We simulated the effects of APT on chlamydia transmission by (1) increasing the number of treated partners by 5%, 10%, 15%, 20% and 25%, and (2) reducing the time to partner treatment by 1, 2 and 3 days compared to standard PN. We then calculated the relative reduction in prevalence 5 years after the implementation of APT.

FIGURE 5.

Schematic illustration of chlamydia transmission model.

Susceptible individuals S_ij can become symptomatically and asymptomatically infected (I_S,ij and I_A,ij). Infected individuals can then become notified (P_S,ij and P_A,ij) by their partners. All infected individuals can receive treatment to become susceptible again, or acquire temporary immunity (R_ij) through spontaneous clearance of the infection. Movement of individuals into and out of the population is omitted in the scheme. Subscripts i and j denote sex and sexual activity groups, respectively. A more detailed description of the model structure is given in Althaus et al. 44

Limitations

First, we considered notification of the index case’s most recent partner only. This was a necessary simplification of our modelling framework. As the average number of notified partners is typically below one, we expect that including notification of additional partners in our model would not substantially affect our results. Second, we did not consider reinfection of index cases by untreated partners. This aspect was investigated in a separate study (study 2 of Stream B). Finally, the model does not include data from the RCT as the studies were run in parallel.

Key findings

We found that chlamydia positivity is highest in partners of symptomatic index cases with low sexual activity, whereas the infected partners are typically asymptomatic and highly sexually active. Conducting PN for this particular index–partner combination will thus be most effective for preventing further transmission. Increasing the number of treated partners from current levels in Britain [0.51, 95% credible interval (CrI) 0.21 to 0.80] by 25% would reduce chlamydia prevalence by 18% (95% CrI 5% to 44%) in both women and men within 5 years (see Figure 5). In contrast, reducing the time to partner treatment alone had a minor effect on reducing prevalence. Together, these results suggest that PN typically identifies sexual partners that are likely to further transmit chlamydia, and that APT in particular has the potential to further reduce prevalence through an increase in PN uptake.

Interrelation with other parts of the Programme

First, the results of this study on chlamydia positivity in partners of index cases help to better interpret the outcomes of the RCT. Second, simulated data from the model were used as input parameters for modelling reinfection with chlamydia (study 2 in Stream B) and the cost-effectiveness analysis (study 3 in Stream B).

The projected effect of APT on chlamydia prevalence after 5 years is shown in Figure 6.

FIGURE 6.

Projected effect of APT on chlamydia prevalence after 5 years.

APT is modelled as an increase in the number of treated partners (left) or a reduction in the time to partner treatment (right). Changes in prevalence are given for females (red) and males (blue). Note the difference in scales of the axes between the left and right panels.

Aim and objectives

The expected effects of APT on the reinfection of treated index cases by untreated partners with chlamydia remain unclear. We did not consider reinfection of treated index cases in the transmission model (study 1 of Stream B). Here, we analysed data from the RCT using another mathematical model and quantified the effects of offering APT on the probability of successful partner treatment.

Methods for data collection and analysis

We extended a previously developed mathematical model42 to compute the probability of chlamydia reinfection of index cases by their untreated partners with chlamydia. We fitted the model to data from the RCT and estimated the probability of successful treatment of the partner of index cases in a Bayesian framework.

Limitations

The model does not distinguish between reinfection in women and men and considers reinfection by a single partner only. Furthermore, the remaining uncertainty in some key parameters together with the relatively small numbers in the primary outcome of the RCT result in considerable uncertainty of the modelling results.

Key findings

We estimated the median probability of reinfection at 16.2% (50% CrI 12.7 to 20.0%) without partner treatment and 2.3% (50% CrI 1.7% to 3.6%) when partner treatment is 100% successful. The observed rates of reinfection in the RCT correspond to a median probability of successful partner treatment of 63% (50% CrI 47% to 75%) during the control period and 77% (50% CrI 64% to 87%) during the intervention period, where APT was offered in addition to standard PN. Hence, the study suggests that the observed reduction in reinfection with chlamydia when offering APT is consistent with a higher probability of successful partner treatment.

Interrelation with other parts of the Programme

The results of this modelling study help to better interpret the effect of offering APT on the primary outcome of the RCT (Stream A).

Aims and objectives

We estimated the cost effectiveness of APT compared with standard PN in terms of MOA and QALYs gained to assess the long-term impact of APT on chlamydia and its sequelae at the population level.

Methods of data collection and analysis

We developed a static spreadsheet-based model using output from the chlamydia PN model (Stream B phase 1) to estimate the impact of APT on healthcare costs and numerous health outcomes: mild and severe PID, ectopic pregnancy, tubal factor infertility, chronic pelvic pain, epididymitis and QALYs in a population of 100,000 adults aged 16–34. 46 Estimates of resource use and unit costs were drawn from the Stream A within-trial CCA and suitable published secondary sources. Probability values relating to the complication were drawn from suitable published secondary sources. Utility values informing QALYs were obtained from a primary study (for female complications) and published literature (for epididymitis). Our base-case analysis assumed that APT increased the number of partners treated from current levels by 25%.

We calculated incremental cost-effectiveness ratios (ICERs) for APT versus standard PN in terms of cost per MOA and cost per QALY gained. We then conducted extensive deterministic sensitivity analyses and a probabilistic sensitivity analysis to assess parameter uncertainty. Lastly, we conducted scenario analyses whereby the increase in the number of partners treated by APT was lowered to 15%, 10% and 5%, respectively.

Limitations

Firstly, the analysis did not consider the effect that repeat or persistent chlamydia/PID would have on tubal damage. Secondly, only an IP’s most recent partner was considered in the analysis. Thirdly, due to a lack of availability, robust utility values were not used for epididymitis. Lastly, the analysis made no comparisons for different forms of APT (e.g. APT Pharmacy,20 which was considered by a previous CCA36).

Key findings

The base-case results, which assume that APT increases the number of partners treated by 25%, showed that APT is less costly and more effective in terms of MOA and QALYs than standard PN, hence is cost-saving. Deterministic sensitivity analyses found that APT remained either cost-saving or cost-effective, the latter with ICERs that were very low and well within acceptable thresholds. APT remained cost-effective when the increase in the number of partners treated by APT was lowered to 15% and 5%, respectively; however, it was more costly than standard PN.

Interrelation with other parts of the Programme

The health economic analysis of Stream B models the long-term effects of APT versus standard PN and thereby complements the trial and CCA from Stream A that measure the short-term effects. It additionally draws estimates of resource use and unit costs from the Stream A CCA. The cost-effectiveness model relies on simulated data about the long-term effects of standard PN and APT from the dynamic transmission model (Stream B phase 1). 44

Aim and objectives

We conducted a systematic review of economic studies of PN interventions for STIs in MSM. PN often involves testing and treatment of SPs; hence, to ensure a comprehensive inclusion of all PN-related interventions, we also explored studies associated with testing and treatment strategies.

Methods for data collection and analysis

We undertook a systematic review according to the guidelines of the UK‘s Centre for Reviews and Dissemination (CRD)47 and reported this following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. 48 A search strategy was developed using the population, intervention, comparison and outcomes (PICO) framework. 49 A scoping search was carried out on Google Scholar and MEDLINE. This was followed by a search on six electronic databases including MEDLINE, EMBASE, Web of Science, NHS Economic Evaluation Database (NHS EED), HIMC and cumulative index to nursing and allied health literature (CINAHL), up to June 2020. The reference lists of potentially key papers were hand-searched to identify additional papers. Search results were entered into the endnote database manager,50 to exclude irrelevant studies and code relevant studies.

Inclusion and exclusion criteria: formal economic evaluation and cost-analysis studies were included if participants were MSM who had any STI and/or HIV and the intervention was related to PN, testing or treatment. Studies were excluded if they were editorials, reviews or reports on the use of technology for interventions not related to PN, such as health promotion and education.

Study selection: a two-stage process was used to screen studies for inclusion using published methods. 51,52 Studies were categorised independently by two reviewers. A formal quality appraisal was not conducted because the review’s objectives required a description of all economic evidence but not a methodological assessment.

Data extraction and synthesis: a bespoke data extraction form was developed based on the study objectives and subsequent planned analysis. Data were extracted and checked for consistency by two reviewers. Relevant information was tabulated to facilitate comparison across studies and evidence was summarised using a narrative synthesis.

Limitations

The systematic review benefited from a comprehensive search using best practices. The review provides useful information on the cost of PN for STIs/HIV in MSM that could potentially be used as model inputs for any future model-based analyses. We had anticipated that evidence from this review would be used to develop a preliminary decision-analytic model to explore the cost effectiveness of alternate pathways developed in the Programme. However, this was possible because we did not identify any consistent pathways to evaluate. Furthermore, we identified no studies focusing on the costs and outcomes associated with digital technologies for PN.

Key findings

The systematic review selected 26 studies out of a possible 1909. Overall, 11 studies included PN strategies in the assessment, while 15 studies focused on testing and/or treatment, 16 papers focused on MSM, but only 3 of these were on PN, indicating a paucity of PN studies in this population. The review did not identify any PN studies on MSM for curable STIs, including chlamydia. However, two studies on HIV that reported on PN in this population were identified. Few studies reported on patients’ characteristics and settings.

The studies (22) were mostly formal economic evaluations, with only four cost analyses. The majority of the economic evaluations were cost-utility analyses with outcomes reported as QALYs which were derived from studies on heterosexual people due to a lack of data on MSM. These may not be directly relevant to MSM given the different patterns of SPs reported by these two groups. Few studies reported cost components or types of resource use to identify the costs none of these cost studies was relevant to digital PN. The studies mostly derived their data from secondary sources and only six used data from primary sources. Information on partner types or digital PN was not available within the selected studies. There was also little information on using a digital tool for PN, with just one paper53 reporting the use of an online PN tool. The lack of evidence on efficient approaches for MSM supports the need for new interventions with parallel economic evaluation.

Interrelation with other parts of the Programme

The dearth of appropriate economic evidence highlighted by this review supports a call for future research in this area to embed economic evaluation and associated appropriate data collection so that the process evaluation as outlined in Stream C can be used to develop models to explore a novel PN approach for MSM with STIs and aid decision-making.

Aim and objectives

The original aim was to investigate the effects of improved PN interventions in MSM with gonorrhoea on identifying sexual partners that are infected with Neisseria gonorrhoea, HIV or both. In recent years, the research questions with respect to PN in MSM have changed due to the introduction of HIV PrEP which has become an accepted biomedical HIV prevention intervention. 54 We aimed to develop a gonorrhoea/HIV co-infection model for MSM.

Furthermore, we summarise the recent modelling literature on PN and PrEP in MSM to identify future research questions.

Methods of data collection and analysis

We attempted to extend the modelling framework from Stream B (phase 1) to include gonorrhoea/HIV co-infection and fit it to incidence and prevalence of gonorrhoea and HIV. We searched the literature for novel mathematical modelling studies on bacterial STIs, HIV, PN and PrEP.

Limitations

The development of the gonorrhoea/HIV co-infection model did not extend beyond an experimental phase. First, fitting the model to data about both infections, using the same method as in Stream B (phase 1), did not result in convergence of posterior parameter distributions. Second, the PN module could not be easily extended to co-infections within the time frame of the project. The existing literature on modelling PN in MSM focuses on expedited partner therapy (EPT)55–57 as carried out in the USA, in which an IP is given additional (oral) antibiotics to deliver to SPs. The findings are thus not generalisable because current treatment for gonorrhoea in many countries is parenteral due to the concerns about the efficacy of oral cefixime treatment.

Key findings

We identified several challenges when attempting to fit the compartmental gonorrhoea/HIV co-infection model to data. The issues we experienced with parameter identifiability need to be addressed in future modelling studies that aim to provide quantitative estimates of interventions in MSM. However, the results from existing modelling studies shed light on the potential effects of PN and PrEP in MSM. First, a network-based model of HIV/gonorrhoea/chlamydia found that PrEP in combination with HIV/STI screening recommendations could result in a significant decline of gonorrhoea and chlamydia in MSM. 58 Second, an agent-based simulation model of HIV/HIV/gonorrhoea/chlamydia Neisseria gonorrhoea/Chlamydia trachomatis illustrated that targeted delivery of PrEP to people diagnosed with gonorrhoea and chlamydia could increase the effectiveness of PrEP and reduce incidence of all STIs. 59 Finally, a network-based model highlighted the potential of EPT in MSM to reduce gonorrhoea and chlamydia infections but raised concerns about a possible increase in antimicrobial resistance and missed opportunities for HIV prevention. In summary, the recent modelling studies underline the importance of PrEP for prevention of HIV as well as bacterial STIs. Future modelling studies should consider PN interventions in presence of PrEP.

Interrelation with other parts of the Programme

The reported findings inform the development of appropriate PN interventions for MSM.

Aim and objectives

To enhance patient choice and improve public health by developing acceptable, theoretically informed, evidence-based, PN interventions (tailored according to SP type)

(1) To optimise APT for MSM; (2) to examine psychosocial aspects of PN amongst MSM; (3) to respond directly to emerging insights from the wider research Programme (i.e. the need to tailor PN interventions by SP type) and develop a novel, multilevel, multistakeholder intervention that focuses on improving PN with ‘one-off’ partners – a relationship type known to be particularly challenging for effective PN; to detail intervention content ready for evaluability assessment within further research.

Methods of data collection and analysis

Following new guidance relating to intervention development for complex interventions,2,60,61 we moved away from our initial intention to use exploratory social science (e.g., the use of interpretative phenomenological analysis and cross-sectional surveys). Instead, we used a range of methodological approaches, including stakeholder workshops, in-depth qualitative data through focus groups and in-depth interviews, consultation with PN experts and the application of theories and conceptual tools from behavioural and systems science.

1. Optimising APT amongst MSM: a full account of our methodological and analytic approach and findings generated is presented under Stream A phase 2. Briefly, 14 MSM took part in the wider Programme of work optimising APT. 13

2. We incorporated study of the psychosocial aspects of PN amongst MSM into the wider process of intervention development outlined below in (3). This meant that in addition to exploring these psychosocial aspects we also focused closely on the development of intervention ideas outlined through stakeholder engagement (see details below).

3. In relation to our intervention development work, directed by what we were learning from the wider Programme about the importance of partner type in shaping PN choices,10 we engaged in a multistaged, programmatic approach to intervention development. 62

Partner notification for MSM and their one-off partners is challenging. Findings from earlier parts of the Programme suggested that APT best suits IPs (including MSM) and their more emotionally connected SPs. In order to address the particular challenges of PN solutions for one-off partners, we drew upon ideas from systems science63 to explore novel ways of understanding and responding to the drivers of these poor PN outcomes.

Systems science invites us to consider the complexity of upstream and interdependent drivers of health outcomes and to engage with distal and distributed levers of change. For (3) this meant not assuming that the best place for intervening was within a SHS or through engaging MSM individually in behaviour change. Instead, it meant exploring the wider system which drives PN to understand and detail potential ‘hot spots’ where the simultaneous implementation of diverse future intervention elements across the whole system could make the biggest difference by changing the system itself.

Stage 1: we conducted a stakeholder event with 45 diverse participants from across Britain including MSM, public health experts, service commissioners, multidisciplinary sexual HCPs, non-governmental organisations (NGOs), academics and dating app providers (dating apps are often used by MSM to find one-off SPs). We focused on exploring the diverse and multilevelled social, cultural and healthcare system-level context shaping poor PN outcomes for one-off partners amongst MSM (see Table 9). We were careful not to prematurely privilege any profession (e.g. health advisors), community (e.g. HIV positive men), service (e.g. NGO STI testing sites) or stakeholder (e.g. dating app providers) as particularly responsible for delivering future intervention content.

We recorded detailed notes and visualisations and analysed them thematically to develop an initial set of ideas for potentially useful future intervention content.

Stage 2: taking the initial ideas for intervention content generated in Stage 1, we collected and analysed much more detailed data to (1) gauge the acceptability of these ideas, (2) further specify and optimise them drawing on participants’ expertise and insights and (3) using tools from behavioural science, to specify potential intervention content at a highly granular level in relation to content, theory, mechanism of action and BCTs.

Given our whole-system focus, it was important to encompass multiple and diverse perspectives on these initial intervention ideas each addressing different hot spots within the system. We aimed to recruit diverse MSMs, diverse HCPs and those involved within the dating app industry.

However, the COVID-19 pandemic impacted on our recruitment plans. We changed our approach to encompass online, in addition to in-person, data collection and completed five focus groups with MSM. Three took place in person (Glasgow, London and Leeds) and two online (n = 28). We systematically explored the psychosocial aspects of PN amongst MSM; intervention ideas relating to interactions between MSM; interactions between MSM with HCPs and SHSs; and MSM’s perspectives on intervention ideas relating to dating app functionality and dating app provider responsibilities.

Despite our best efforts, we only managed to recruit three dating app providers with whom we conducted one-to-one telephone interviews. We systematically explored intervention ideas relating to dating app functionality and dating app provider responsibilities, the potential of dating app provider partnerships with HCPs and public health teams, intervention ideas relating to interactions between MSM; and finally, interactions between MSM with HCPs and SHSs. Our planned focus groups with HCPs were unable to take place due to the national suspension of a range of research activities during the COVID-19 pandemic.

We analysed data from Stage 2 initially using deductive thematic analysis63 and subsequently using the BCW64 to suggest granular intervention content. In this way, Stage 1 had oriented us to where to intervene within the wider system, and Phase 2 showed us exactly how we might do so.

Stage 3: COVID-19 restrictions on HCP participation in research precluded our final planned stakeholder event.

Instead, we held four smaller virtual stakeholder engagement events involving a broad range of participants from NGOs (n = 6) and PN experts drawn from the wider LUSTRUM team (n = 5 including health advisors, nurses, and doctors). Participants appraised the detailed intervention suggestions outlined within Stage 2 and using the APEASE criteria,19 discussed potential for implementation across the whole system. The outline of our systemic intervention is illustrated in Figure 7.

FIGURE 7.

The agreed focal points to be operationalised within future interventions.

Light blue elements – consensus of intervention content to be included within future interventions. Orange elements – some support for intervention content in this area within future interventions. White elements – intervention content developed in Stage 1 and 2 but rejected in Stage 3. Light blue arrows – factors associated with facilitating effective contract tracing.

Orange arrows – factors associated with constraining effective contact tracing.

Limitations

We did not collect quantitative data; however, recent European work on PN had been conducted through European MSM Internet Survey (EMIS),65 and this was incorporated into the initial stakeholder event. The COVID-19 pandemic meant that it was not possible to include HCPs within Stage 2 of the intervention development process and although we could compensate in part by asking MSM about their interactions with HCPs, and through our inclusion of HCP experts in the final round of stakeholder engagement, the lack of systematic data and analysis of HCP perspectives on PN with one-off partners remains a limitation.

Key findings

Although we had envisaged that we would focus on optimising APT for the specific needs and preferences of MSM, and that a modified form of APT would be our developed MSM intervention, Programme findings about the importance of tailoring PN interventions to different partner types meant that in addition to optimising APT for MSM (and their more emotionally connected partners), we also developed recommendations for a multilevel, multi-stakeholder intervention targeting MSM with one-off partners, for whom PN is known to be particularly challenging.

Key areas for a multilevel, multistakeholder intervention that could simultaneously address various aspects of the system that drives poor PN outcomes amongst MSM included acknowledging everyone has a part to play; modifying the cultural and social context of MSM communities; improving skills, practice and service organisation of HCPs and their services to better accommodate PN for one-off partners; working with dating app providers to explore possible digital PN options through dating apps, or stand-alone online PN platforms.

Close partnership working between MSM, NGOs, HCPs and dating app providers across the system was perceived to be important. A series of coterminous and interdependent intervention components together may change the whole system that drives poor PN outcomes (i.e., push the system to ‘a tipping point’).

Multiple reinforcing positive feedback loops may be possible that cascade change effectively without over-burdening any particular part of the system (e.g. HCPs).

Key intervention elements included a coordinated and co-produced mass and social media intervention that changes the norms and beliefs of MSM to challenge STI-related stigma and other barriers to notification; NGO’s leading funded peer-led work reducing stigma and persuading MSM to actively participate in notification to protect others and their communities, stressing the value and importance of PN (e.g. using key opinion leaders in MSM communities online and off); HCPs and their services to prime MSM to prepare for a PN interaction at the point of diagnosis (e.g. by thinking through the types of sexual partner they have had and their contact details and the kinds of notification that is appropriate), changing national audits and monitoring systems to directly address one-off partner PN outcomes, bespoke training to HCPs and NGO staff on issues for one-off partners and the social and cultural context of MSM ensuring they demonstrate cultural competency and reinforce the importance of PN; dating app providers promoting appropriate PN messaging and being active collaborators throughout. More detailed intervention elements include public health messages and materials to educate MSM on PN, virtual or real-world training opportunities for MSM modelling how to contact partners after a diagnosis (e.g. suggestions for wording of how to tell a one-off partner), how to respond to being notified of increased risk (suggestions for wording), targeted, punchy messaging about contact tracing and management for one-off partners. Stakeholders suggested an intervention could be branded with 4T’s: ‘Test, Treat, Trace, Tell’ with messaging branded by reputable organisations endorsing notification. Intervention content should also be co-produced with and being visibly inclusive of a diverse range of MSM.

Interrelation with other parts of the Programme

These elements are closely related to Stream A, ‘optimisation of APT’ and build very clearly on the results of the main trial and the findings relating to the importance of partner type in the choices of PN approach. They also touch upon the problems of implementing APT outlined within the process evaluation and have oriented future solutions to PN outside SHSs rather than adding to the existing service burden. 66

Which groups of people were represented in our research, and how did we involve them?

The LUSTRUM Programme was funded and designed to improve the sexual health of people most impacted by STIs and HIV by preventing transmission and reducing undiagnosed infections. National data show that young heterosexual people and MSM are most likely to be diagnosed with STIs. In line with the data, the LUSTRUM Programme involved people who identify as either a young heterosexual person or a MSM. We were aware that these two groups are very broad, so we identified people from different sexual health clinics and community-based SHSs throughout England and Scotland. By including people from London, metropolitan ‘cities’ and non-London urban ‘towns’, we gained representation from broad geographic areas and different levels of social poverty. In addition to broad geographic representation amongst the people who took part in our studies (participants), we achieved representation from men, women, people who identify as heterosexual, MSM, plus a wide range of ages, with the average being 24 and ethnicities (including White British/Irish/other, black/Black British, mixed ethnicity and other ethnicities) within these. We also worked with 25 people with mild learning disabilities, 56 members of the public and patients and 30 HCPs to help us improve APT so that it was suitable for as many different types of people as possible.

The focus of the Programme was on groups that national data show experience an unequal burden of Chlamydia infection. In the future, we would continue to review the most up-to-date data, about groups most affected by STIs, with particular attention to those not included in this Programme following any changes in the epidemiology of STIs. This is so that we can explore and address any PN and management needs of other groups that could benefit from innovations in PN.

Inclusion and accessibility of participant and public engagement materials

Throughout the Programme, we aimed to include public perspectives in the design, delivery and dissemination of the research with varied audiences. We did this to increase the likelihood of our research being relevant, acceptable, effective and impactful. We considered the needs of current and future users of sexual health care and those of the HCPs that deliver SHSs. To do this, we created a virtual patient and public involvement and engagement (PPIE) panel and consulted regularly with wider stakeholders, including people with recent experience of STI testing and diagnosis.

All public-facing, text-based and image-based documents were reviewed by representatives from our PPIE panel before being published or shared more widely. This included recruitment materials, website text, explanations of the trial design and programme branding. Their suggestions and questions helped us improve the language, accessibility and understanding of our outputs (including the Plain language summary of this report).

Following a recommendation from a lay contributor, we produced explainer videos and instruction videos to support trial participants in taking their own STI samples. We worked with PPIE members to develop the video scripts and concepts. These videos presented information in a short, engaging and informative way. In each video, the main character was either from a racially marginalised community and/or had a lesser-heard regional accent. The public-facing explainer video received 670 views and, in total, all public-facing videos received over 4100 views. In our final video summarising the trial findings, we received feedback from a member of the public that an animation style may work better – we took this on board. In the animation video, we intentionally showed a range of genders, ethnicities, sexual orientations, partnership types and religions on screen to make the video more accessible to a wide audience. We also used simple, lay-friendly language.

Diversity and inclusion among the LUSTRUM research team and associates

The LUSTRUM Programme team is a diverse group. We ranged in age from early 20s to 60s and included a range of genders, ethnicities, sexual orientations, cultural identities. The team also had both personal and professional experiences of STI. Importantly many team members have intersectional identifies, broad life experiences and non-traditional career paths. The research has benefited enormously from the perspectives offered by our truly diverse team that is able and enthusiastic about engaging in challenging discussions concerning inequalities, wider determinants of health and reflecting critically on our research approaches.

The ‘whole systems’ and progressive nature of this research programme required a multidisciplinary research team which included clinicians, health psychologists, epidemiologists, social scientists, statisticians, public health professionals, economists and mathematical modellers. The team was geographically diverse, including members from urban metropolitan settings in London, Birmingham and Glasgow and rural areas such as Wessex and further afield, colleagues in Bern, Switzerland. This geographical diversity complemented the multidisciplinary team and helped us achieve true diversity of thought. We engaged in reflective meetings where we questioned underlying assumptions of different disciplines and health systems to help our understanding. This breadth of knowledge, networks and professional interests supported external multidisciplinary expert consultation, including within Stream C, where we explored diverse social, cultural and healthcare system levels.

Team members reflected different levels of seniority, across and within disciplines, which supported peer-to-peer learning, mentoring, reverse-mentoring and career development opportunities. For example, the key post-doctoral role holder on the LUSTRUM Programme has now secured a management role on a new programme grant, a research assistant from a minority ethnic background developed an interest in and is now pursuing an academic career and another team member is using her research knowledge in an industry-specific role. One of the HCPs that worked closely with the research team has also been inspired to explore career opportunities in research.

Development opportunities were also provided to those outside of the core staff group. In the first year of the programme, we provided research experience placements for medical students, the majority of whom were from non-white ethnic backgrounds. Further, over several years, we provided 3-month placements to three students on University College London (UCL) Behavioural Psychology Master’s programme.

Both the research team members, the programme of research and the service users and members of the public involved in this study have gained enormously from a considered approach to equity, equality, diversity and inclusion and are grateful for the opportunity that NIHR is providing for us to share our learnings and achievements. In future work, we would continue to consider the protected characteristics, as a baseline for our work, plus any other factors which may support/challenge engagement with and progression within research.

Aims

• To include public perspectives in research design, conduct and dissemination.

• To increase relevance, acceptability, effectiveness and impact of the programme.

• To address the needs of current and potential users of sexual health care and the HCPs that deliver them.

Approach and methods

Traditional PPIE approaches are less acceptable within sexual health research. Stigma can mean that people avoid discussing experiences of STI care in public fora and the transience of many STIs means that service users do not tend to form enduring links with clinical services. We adopted an innovative, virtual approach by maintaining and expanding ‘Barts Sexual Health Public Voice Research Group’, composed of 27 diverse lay people interested in/users of SHSs.

Communication was mostly by e-mail and our website. 67 Members fed back directly to the Programme Manager instead of through collective discussion, enabling sharing of opinions whilst preserving anonymity. A PPIE representative(s), prepared/debriefed by a researcher, attended all levels of Programme meetings as appropriate.

Key outcomes

• Better decision-making, informed by public views on research design and conduct.

• Improved language, accessibility and understanding of our outputs (including the Plain language summary of this report).

• Feedback on study documentation, including lay explanation of the trial design and programme branding.

• Advice on research outputs, including, the novel classification of SP types.

• Directly informed ethical considerations, underpinning our decision to pursue service level consent in the RCT.

• Co-development of a GDPR-compliant solution for permission for research data use and contribution to a related scientific manuscript. 27

• Joined expert workshop discussions with the BASHH and co-produced the first national recommendations for STI and BBV self-sampling packs and processes. 7

• Shared lay views at a national British HIV Association/BASHH conference panel discussion.

• Assisted production of a video summarising the RCT findings (over 200 views).

The PPIE Group and our lay representatives have also been invaluable in achieving the Programme’s research aims:

Using a dedicated YouTube channel,68 we increased engagement with a broader audience including:

• A video series of ‘explainer’ clips about APT (the public-facing video received three times the views of the professional-facing video).

• Videos demonstrating how to use STI self-sampling kits, initially intended for RCT use, were also used by the public (over 3000 views).

Patient and public involvement and engagement increased stakeholder engagement, using Twitter and highlighted driven traffic to our key outputs and created interest in dissemination events including conference presentations and scientific-lay webinars.

Discussion and reflections

Through our innovative virtual PPIE approach, we maximised the impact and relevance of the LUSTRUM Programme in academic, service delivery and non-research settings, within a stigmatised health area. In future, we will work with our PPIE group to explore ways of facilitating group-based discussion in a way that is acceptable to lay contributors so that the benefits of collective discussion can be realised. Furthermore, although we captured some demographic information from PPIE members, we would attempt to do this systematically, if acceptable, to better enable us to assess and fill any gaps in diversity of backgrounds and experiences.

Peer-reviewed papers

Mercer CH, Jones KG, Johnson AM, Lewis R, Mitchell KR, Gravningen K, et al. How can we objectively categorise partnership type? A novel classification of population survey data to inform epidemiological research and clinical practice. Sex Transm Infect. 2017;93(2):129–36. http://doi.org/10.1136/sextrans-2016-052646

Saunders J, Mapp F, Wayal S, Pothoulaki M, Estcourt CS. Response to van Aar et al. STIs in sex partners notified for chlamydia exposure: implications for expedited partner therapy. Sex Transm Infect. 2018;94:619–21. http://doi.org/10.1136/sextrans-2017-053364

Estcourt CS, Howarth AR, Copas A, Low N, Mapp F, Owusu MW, et al. Accelerated partner therapy (APT) partner notification for people with Chlamydia trachomatis: protocol for the Limiting Undetected Sexually Transmitted infections to RedUce Morbidity (LUSTRUM) APT cross-over cluster randomised controlled trial. BMJ Open. 2020;10(3):e034806. http://doi.org/10.1136/bmjopen-2019-034806

Middleton A, Pothoulaki M, Owusu MW, Flowers P, Mapp F, Vojt G, et al. How can we make self-sampling packs for sexually transmitted infections and bloodborne viruses more inclusive? A qualitative study with people with mild learning disabilities and low health literacy. Sex Transm Infect. 2021;97(4):276–81. http://doi.org/10.1136/sextrans-2020-054869

Estcourt CS, Flowers P, Cassell JA, Pothoulaki M, Vojt G, Mapp F, et al. Going beyond ‘regular and casual’: development of a classification of sexual partner types to enhance partner notification for STIs. Sex Transm Infect. 2022;98(2):108–14. http://doi.org/10.1136/sextrans-2020-054846

Estcourt CS, Stirrup O, Copas A, Low N, Mapp F, Saunders J, et al. Accelerated partner therapy contact tracing for people with chlamydia (LUSTRUM): a crossover cluster-randomised controlled trial. Lancet Public Health 2022;7(10):e853–65. https://doi.org/10.1016/S2468-2667(22)00204-3

Flowers P, Pothoulaki M, Vojt G, Mapp F, Owusu MW, Estcourt C, et al. Understanding the barriers and facilitators to using self-sampling packs for sexually transmitted infections and blood borne viruses: thematic analyses supporting intervention optimisation. Br J Health Psychol. 2022;28(1):156–73. https://doi.org/10.1111/bjhp.12617

Flowers P, Pothoulaki M, Vojt G, Mapp F, Owusu MW, Estcourt C, et al. Using the behaviour change wheel approach to optimise self-sampling packs for sexually transmitted infection and blood borne viruses. Br J Health Psychol. 2022;27(4):1382–97. https://doi.org/10.1111/bjhp.12607

Howarth AR, Estcourt CS, Ashcroft R, Cassell J. Building an opt-out model for service-level consent in the context of new data regulations. Public Health Ethics 2022;15:175–80. https://doi.org/10.1093/phe/phab030

Wayal S, Estcourt CS, Mercer CH, Saunders J, Low N, McKinnon T, Symonds M, Cassell JA. Optimising partner notification outcomes for bacterial sexually transmitted infections: a deliberative process and consensus, United Kingdom, 2019. Euro Surveill. 2022;27(3):2001895. https://doi.org/10.2807/1560-7917.ES.2022.27.3.2001895

Pre-prints

(Published on pre-print servers and submitted/planned submission to peer reviewed journals)

Vojt G, Smith M, Owusu MW, et al. How do Dating Apps reflect the social organisation of sexual relationships? A review of dating apps and their key features. SocArXiv; 2021. URL: https://osf.io/preprints/socarxiv/wf3vd/

Vojt G, Pothoulaki M, Laidlaw R, Flowers P. What do we know about types of intimate relationship and associated sexual partners – A scoping review of interdisciplinary literature. SocArXiv; 2020. URL: https://osf.io/preprints/socarxiv/fvmqw/

Pothoulaki M, Vojt G, Mapp F, Owusu MW, Mercer CH, Estcourt C, et al. The social organisation of sexual relationships: an exploratory qualitative study. SocArXiv; 2020. URL: https://osf.io/preprints/socarxiv/m4fgb/

Pothoulaki M, Vojt G, Mapp F, Owusu MW, Symonds M, Estcourt C, Flowers P. Accelerated partner therapy: optimising an inter-actional contact tracing intervention to reduce chlamydia reinfection. SocArXiv; 2021. https://doi.org/10.31235/osf.io/zf8y7

Flowers P, Mapp F, McQueen J, The LUSTRUM programme, Estcourt C. Accelerated partner therapy contact tracing intervention for people with chlamydia: the LUSTRUM process evaluation using programme theory. MedRxiv; 2021. https://doi.org/10.1101/2021.08.07.21261736

Althaus CL, Mercer CH, Cassell JA, Estcourt CS, Low N. Investigating the effects of accelerated partner therapy (APT) on chlamydia transmission in Britain: a mathematical modelling study. MedRxiv; 2020. https://doi.org/10.1101/2020.12.07.20245142

Althaus CL, Mercer CH, Cassell JA, Estcourt CS, Low N. Estimating the effects of accelerated partner therapy (APT) on reinfection of index cases with chlamydia: a mathematical modelling study. MedRxiv; 2021. https://doi.org/10.1101/2021.08.11.21261692

Williams EV, Ogwulu CBO, Estcourt CS, Howarth AR, Copas A, Low N, et al. . The cost-effectiveness of accelerated partner therapy (APT) compared to standard contact tracing for people with chlamydia: an economic evaluation based on the LUSTRUM population-based chlamydia transmission model. MedRxiv; 2021. https://doi.org/10.1101/2021.07.27.21261128

Okeke Ogwulu CB, Abdali Z, Williams EV, Estcourt CS, Howarth AR, Copas A, Mapp F, et al. Systematic review of Economic studies of Partner Notification and management interventions for sexually transmitted infections including HIV in men who have sex with men. MedRxiv; 2021. https://doi.org/10.1101/2021.06.08.21258534

McQueen JM, Woode Owusu M, Mapp F, Estcourt CS, Symonds M, Howarth AR, et al. Intervention Development Protocol for a novel, co-produced, sexually transmitted infection partner notification intervention for men who have sex with men. MedRxiv; 2020. https://doi.org/10.1101/2020.10.21.20209049

Flowers P, Gerressu M, McLeod J, McQueen J, Vojt G, Symonds M, et al. . How can we increase notification of exposure to STIs between gay and bisexual men? Intervention development using stakeholder engagement, qualitative methods and behavioural science. MedRxiv; 2021. https://doi.org/10.1101/2021.05.27.21257903

Flowers P, Lasoye S, McQueen J, Woode Owusu M, Symonds M, Estcourt C. Developing a co-produced, systems-informed, sexually transmitted infection contact tracing intervention for gay and bisexual men who have sex with men and their ‘one-off’ sexual partners. MedRxiv; 2021. https://doi.org/10.1101/2021.07.07.21260064