Abstract
BACKGROUND
Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England.
OBJECTIVES
The study (Santé) had two main objectives - (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care.
DESIGN
The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen.
SETTING
SH clinics in England.
PARTICIPANTS
Young people (aged 16-25 years), and men who have sex with men.
INTERVENTION
A three-part intervention package - (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients.
MAIN OUTCOME MEASURES
The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial).
RESULTS
We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%).
LIMITATIONS
Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT.
CONCLUSION
We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN16738765.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 12. See the NIHR Journals Library website for further project information.
Plain language summary
Reducing sexually transmitted infections (STIs) is a public health priority. Those most likely to be diagnosed with a STI are young people (aged 16–25 years) and men who have sex with men. Studies in other countries have shown that interventions aimed at changing sexual behaviour (e.g. increasing condom use) can reduce the chance of getting new STIs in patients attending sexual health (SH) clinics. However, it is not clear if these interventions will work in English sexual health clinics, or if they could be implemented within existing resources. This study aimed to find out if effective interventions could be adapted to an English setting and tested this in a randomised trial. The scientific literature was searched for potential interventions and 33 trials were found. Effective methods included videos, digital web-based interventions, self-testing kits and talking sessions (e.g. counselling). Patients and providers were asked which interventions were acceptable and preferences for digital and one-to-one talking interventions were found. Providers suggested that these were feasible to deliver. Data routinely collected from patients (e.g. number of partners) were used to select patients at a higher risk of having a STI, a computerised risk score calculation was developed, and the highest risk group was directed to a one-to-one counselling intervention. There were no appropriate digital interventions available; therefore, a stand-in web page was created to signpost users to appropriate SH resources. This was offered to all patients. The intervention package was piloted in two SH settings rather than the planned four because of a lack of clinic staff time and space. It was planned to follow up a subset of patients from all eight clinics 6 weeks after their visit to collect information on STI diagnoses. Patients were recruited from six clinics, but only 16% of patients completed the survey and returned a sample. It was not possible to conclude definitively whether or not a randomised trial is feasible because of challenges in implementation and recruitment.
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