Evaluation of dual Point-Of-Care Tests for HIV/Syphilis for MSM V2
Research type
Research Study
Full title
Clinic based evaluation of SD BIOLINE HIV/Syphilis Duo (Alere) and DPP® HIV-Syphilis Assay (Chembio) for the screening of HIV and syphilis in men who have sex with men in in the STI screening facilities of Brighton and Hove, United Kingdom (UK).
IRAS ID
244187
Contact name
Nigel Sherriff
Contact email
Sponsor organisation
University of Brighton
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
To diagnose HIV and Syphilis, blood is usually drawn from the vein and then separate tests conducted for each infection in a suitable laboratory. Results from these ‘gold-standard’ tests can take between 2-5 days to confirm (or not) a diagnosis. This can be an anxious wait for the patient and there is a risk of transmission to other sexual partners in the interim period. Moreover, the technical procedure to conduct these tests in the laboratory can be demanding and require equipment not widely available in resource-limited settings (e.g. low/middle-income countries). Recently, tests have been developed that are capable of detecting HIV and syphilis infections simultaneously using blood pricked from the finger rather than taken from the vein. Results of these tests can be delivered to the patient within 20-30 minutes. Such point-of-care tests (POCT) or rapid tests are commercially available and have shown encouraging performance compared to laboratory-based studies; but there is very limited data on their accuracy in non-laboratory settings. According to the World Health Organization (WHO), evaluation of these new dual POCTs in clinic-based settings and their acceptability to patients and health professionals is therefore a high priority. \n\nConsequently, the Reproductive Health and Research Department of the WHO have established a global study called ProSPeRo: the global Project on Sexually Transmitted Infection Point-of-care Testing. The overall objective of ProSPeRo study is to provide advice to WHO Member States and other public health institutions on the performance of commercially available STI diagnostic tests that can be used at the point-of-care. This present clinic-based evaluation represents the UK arm of the ProSPeRo study and will evaluate two dual POCTs for the screening of HIV/syphilis in men who have sex with men in the screening facilities of the Sexual Health and Contraception Service (SHAC), based in Brighton, UK.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1058
Date of REC Opinion
30 Jul 2018
REC opinion
Further Information Favourable Opinion