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Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users


Author
Saunders et al.

Publication year
2017

Country

Type of approach
Community-based

Type of assistance
Unassisted

Specimen
Fingerstick/whole blood

Study population
Key population: Men who have sex with men

Study design
Feasibility/acceptability

Sample size
200

UNAIDS HIV prevalence (2017)
0.19

Methodology
Observational study to determine the ability of clinic attendees to follow the instructions, complete the test on themselves and correctly interpret the results. Participants interpreted three possibilities of contrived results, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included; participants were not given any further verbal instructions or assistance by the researcher. Study period: November 2014 to March 2016

Summary of findings
Two hundred participants were recruited. 97.0% (95% CI 93.5 to 98.9) conducted the test so as to achieve a valid result. 99.5% correctly identified the test result. Participants correctly interpreted the result of 94.0% (95% CI 91.4 to 95.9) of 586 contrived devices. 3% of participants had difficulty using the finger-prick lancet (n=6/199) and 4% had difficulty expressing blood or collecting a sample (n=8/199), although not to a degree that meant that the test was unable to be performed.

Acceptability
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
n/a

Specificity
n/a

Concordance
0.94

HIV positivity
0.5% (1/193)

Accuracy details
94.0% (95% CI 91.4 to 95.9) participants correctly interpreted the result of 551 contrived devices.

Social harm
n/a

Linkage to prevention, care and treatment
A single participant had a reactive test result which was confirmed on a second point-of-care test, and a laboratory test.


Study status
Completed