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Accuracy and acceptability of oral fluid HIV self-testing in a general adult population in Kenya


Author
Kurth et al.

Publication year
2016

Country

Type of approach
Dual

Type of assistance
Unassisted

Specimen
Oral-fluid

Study population
General population: General adult population

Study design
Feasibility/acceptability

Sample size
239

UNAIDS HIV prevalence (2017)
5.9 [4.9 - 7.0]

Methodology
This study evaluated performance, accuracy, and acceptability parameters of unassisted oral fluid HIVST in a general population in western Kenya. In a prospective validation design, we enrolled 240 adults to perform rapid oral fluid HIVST and compared results to staff administered oral fluid and rapid fingerstick tests. All reactive, discrepant, and a portion of negative results were confirmed with lab ELISA.

Summary of findings
Twenty participants were video-recorded conducting self-testing. All participants completed a staff-administered survey before and after HIVST to assess attitudes towards oral fluid HIVST acceptability. HIV prevalence was 14.6%. Thirty-six of the 239 HIVSTs were invalid (15.1%; 95% CI 11.1-20.1%), with males twice as likely to have invalid results as females. HIVST sensitivity was 89.7% (95% CI 73-98%) and specificity was 98% (95% CI 89-99%). Although sensitivity was somewhat lower than expected, there is clear interest in, and high acceptability (94%) of oral fluid HIV self-testing.

Acceptability
0.94

Acceptability details
94% think/feel that HIV self-testing will be/is acceptable.

Willingness to pay
US$ 1.25

Willingness to pay details
The mean price people were willing to pay for an HIVST was 111 Ksh, around US$1.25 (range 0-1000 Ksh) (n=n/a).

Sensitivity
0.897

Specificity
0.98

Concordance
n/a

HIV positivity
14.3% (29/203)

Accuracy details
HIVST sensitivity was 89.7% (95% CI 73-98%) and specificity was 98% (95 % CI 89-99%). Among the 239 oral fluid HIV self-testing results, 36 (15.1%; 95% CI 11.1-20.1%) were invalid. Cohen's kappa was 0.89 (95% CI .78-.99) for agreement between oral fluid HIVST and ELISA and was .92 (95% CI .84-.99) for agreement between oral fluid HIVST and staff fingerstick results.

Social harm
n/a

Linkage to prevention, care and treatment
A blood specimen was drawn for ELISA confirmatory testing (Vironostika HIV Uni-Form II Ag/Ab; bioMe'rieux Inc.) at the time of any reactive, discrepant, or indeterminate/invalid OF/FS test results.


Study status
Completed