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Feasibility of a trial of risk reduction in sexual health clinics

Sexual risk reduction interventions for patients attending sexual health clinics; feasibility to conduct an effectiveness trial (Sante project)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16738765
Enrollment
16000
Registered
2015-08-05
Start date
2015-07-09
Completion date
Unknown
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Infectious diseases and microbiology, Public health

Interventions

Current interventions as of 08/02/2017: The plan is to carry out 5 interlinked activities during the formative work, and then a pilot feasibility study. The formative work consists of:

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Service providers: 1. Any of service manager and professional members of the multidisciplinary team (doctors, nurses, health advisors, psychologists) 2. Working at sexual health services including: Genito-urinary medicine (GUM), contraceptive and sexual health (CASH) or Brook clinic Patients: 1. Attendance at a GUM, CASH or Brook clinic 2. 16 years or older Target Gender: Male & Female ; Lower Age Limit 16 years

Exclusion criteria

Exclusion criteria: Service providers: 1. In post for less than 3 months Patients: 1. Younger than 16 years 2. Lacking capacity to give informed consent 3. Unable to speak English

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 08/02/2017: Acceptability of the intervention package to users and HCP as measured by: 1. Proportion of service users who attend the clinic that are scored by triage tool 2. Proportion of those who score high who are offered the intervention 3. Proportion of those who are offered the intervention who take up the intervention 4. Proportion who take up the intervention who complete the intervention 5. Reasons for not completing the intervention from service users 6. Acceptability of the intervention from the provider perspective The primary outcome measures will be measured using mixed-methods throughout the period of the pilot intervention. The process data will be collected during the service users attendance at the sexual health clinic, and recorded in the electronic patient record. Qualitative data will be collected from both service users and service providers throughout the pilot period. Previous primary outcome measures: Feasibility of delivering targeted interventions in sexual health settings; Timepoint(s): December 2016

Secondary

MeasureTime frame
Added 08/02/2017: Feasibility and resources required within the clinic, measured by: 1. The total time spent by service users within the clinical service, compared to normal 2. Total number of service users seen and STIs diagnosed, compared to normal 3. Average consultation time, compared to normal 4. Number of patients seen by health advisors, compared to normal 5. Extra HCP time required for the intervention These outcome measures will be measured throughout the pilot period, from data routinely collected by the clinic’s electronic patient record system. Feasibility of active follow-up in an RCT, measured by: 1. Proportion of service users who consented to the follow-up 2. Proportion of service users who were contactable at 3 months 3. Proportion of service users for whom there was a follow-up STI screen These outcome measures will be measured at the point of patient recruitment in the clinic and at a 6-week follow-up contact.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026