Patient Impact of a diagnosis of Non-specific Genital Infection
Research type
Research Study
Full title
A Feasibility Study investigating the Quality of Life (QoL) and psychosocial impact of a diagnosis of Non-Specific Genital Infection (NSGI) in symptomatic male heterosexual attendees at an NHS Sexual Health Clinic.
IRAS ID
200885
Contact name
Tariq Sadiq
Contact email
Sponsor organisation
St George's University of London
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Heterosexual men with symptoms of urethral discharge or discomfort are routinely tested for only two sexually transmitted infections (STIs): Chlamydia and Gonorrhoea, even though multiple organisms may cause these symptoms. Non-specific genital infection (NSGI) is diagnosed when microscopy of a urethral sample suggests inflammation or infection but urine tests for Chlamydia and Gonorrhoea are negative. Patients diagnosed with NSGI are informed that they may have an STI and receive presumptive antibiotics. There are over 44,000 cases of NSGI diagnosed annually in symptomatic patients attending Genito-urinary Medicine (GUM) Clinics, 70% in heterosexual men.
Rapid multi-pathogen point-of-care STI tests are being developed which may allow fast, specific diagnosis and targeted treatment for symptomatic patients. Patient reported outcomes including their quality of life (QoL) are important in cost-benefit analyses of such novel diagnostics. There are currently no published data on the patient QoL and psychosocial impacts of NSGI diagnosis.This Study will investigate the QoL and psychosocial impacts of a diagnosis of NSGI in symptomatic heterosexual men who attend GUM Clinics, using validated questionnaires. We will compare the impact of a diagnosis of NSGI to that of Chlamydia or Gonorrhoea.
Symptomatic heterosexual men aged 16 or over attending an NHS GUM Clinic will be eligible. Recruits will complete validated QoL, self-esteem questionnaires and questions on relationship status before undergoing standard consultation and testing (baseline) and a similar questionnaire at 0-2 weeks after receiving all of their STI test results (follow-up 1), including questions on their reaction to their diagnosis. Questionnaires will be in Computer Assisted Self Interviewing (CASI) format which patients will access via a secure web-portal on a mobile device. A subset will complete a qualitative interview (follow-up 2) 2-4 weeks after baseline, evaluating their experience of being diagnosed with an infection and patient acceptability of the questionnaires.
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0955
Date of REC Opinion
29 Jul 2016
REC opinion
Further Information Favourable Opinion