Sure Check HIV Self Test - lay user evaluation

• Research type

  Research Study

• Full title

  Sure Check HIV Self Test - lay user evaluation

• IRAS ID

  162422

• Contact name

  Richard Gilson

• Contact email

  r.gilson@ucl.ac.uk

• Sponsor organisation

  BioSure (UK) ltd

• Research summary

  We are conducting an evaluation study to assess the ability of members of the public (lay users) to perform the Sure Check HIV Self Test. This test is approved for use by trained professionals as a point-of-care assay for HIV antibodies.
  The study will recruit participants from among those attending a sexual health service requesting an HIV test. This population is expected to be similar to the target population for the device, those that wish to purchase a self-test for home use.
  The first part of the study will assess the ability of the participant to follow the instructions provided, complete the self-test procedure and obtain and interpret the result correctly. The outcome will be assessed by a researcher who will observe, but not assist, the participant.
  The second part of the study will assess the ability of the participant to interpret the results of 3 contrived devices which will mimic the real device, but enable different potential readouts to the interpreted (against an expert assessor). The devices to be interpreted will selected at random from a panel of 12 devices with differing result appearances.
  The study will enrol 400 participants providing 89% power (5% significance level) to demonstrate that the true result is at least 95%, compared to the expected 98%. If 10% decline to undertake part 2 of the study, 360 participants will provide 91% power to demonstrate the overall correct identification is at least 94%, assuming that 98% of tests can be correctly interpreted. The participants will undergo a standard point of care test for HIV in parallel with the study test (but will not be given the result until they have interpreted their own self-test.

• REC name

  London - Central Research Ethics Committee

• REC reference

  14/LO/1666

• Date of REC Opinion

  29 Sep 2014

• REC opinion

  Favourable Opinion