Intervention Development Protocol for a novel, co-produced, sexually transmitted infection partner notification intervention for men who have sex with men

Introduction The number of bacterial sexually transmitted infections diagnosed among men who have sex with men (MSM) continues to rise annually. Innovative public health interventions are needed to address this. Partner notification (PN), is important in reducing STI transmission by identifying, testing and treating the sex partners of people with STIs. Outcomes of PN in MSM are sub-optimal; some MSM with STIs report high numbers of “one-off” sex partners (where sex occurs on one occasion only) who appear to contribute disproportionately to community transmission but are poorly reached by current PN interventions. Aims/Objectives This paper describes the protocol for development of a novel, co-produced, multi-level, PN intervention for MSM with “one-off” partners. The process described will ensure the intervention is evidence-based, theoretically informed and acceptable to users, service providers, commissioners and those with community interest. Methods and Analysis Our three-phase approach draws on the revised Medical Research Council (MRC) guidance for developing and evaluating complex interventions. First, we combine evidence synthesis with stakeholder engagement to understand the barriers and enablers to PN to co-produce preliminary intervention ideas. Next, we further develop our intervention ideas and adapt our emerging programme theory by collecting detailed data through focus groups and interviews with purposively sampled stakeholders. Data analysis using the theoretical domains framework and the behaviour change wheel will detail the relationship between putative causal mechanisms and optimal intervention components involved in enhancing PN amongst MSM. Finally, we refine our programme theory, map and clarify our intervention and its intersecting components. We will share our intervention with a panel of expert clinicians, third sector organisations and a lay audience of MSM to detail a co-produced PN intervention. Outcome Co-produced intervention and programme theory suitable for testing in a future feasibility study. Ethics and dissemination This protocol received ethical approval from Glasgow Caledonian University HLS/NCH/19/059. Findings will be published with open access licenses. SUMMARY Partner notification for men who have sex with men is suboptimal this paper describes a protocol to develop a co-produced multi-level partner notification intervention. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Protocol ### Funding Statement funded by the National Institute for Health Research (NIHR) (Reference Number RP-PG-0614-20009) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This protocol received ethical approval from Glasgow Caledonian University HLS/NCH/19/059. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes This is a protocol data collection has not yet concluded and data that support the findings of this study will be available from the corresponding author, [Paul Flowers], upon reasonable request.