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Can laypersons in high-prevalence South Africa perform an HIV self-test accurately?


Author
Dong et al.

Publication year
2014

Country

Type of approach
Community-based

Type of assistance
Unassisted

Specimen
Fingerstick/whole blood

Study population
General population: Lay users

Study design
Feasibility/acceptability

Sample size
233

UNAIDS HIV prevalence (2017)
19.2 [18.4 - 20.0]

Methodology
A cross-sectional study where participants tested themselves using a HIVST fingerstick kit (lancet, pipette, alcohol swab, and illustrated instructions designed specifically for self-testing) and supported by a telephone helpline. To assess accuracy of HIVST kit performance, 2 confirmatory tests were performed for comparison: rapid HIV testing performed by trained staff, and laboratory enzyme-linked immunosorbent assay. To assess accuracy of result interpretation, participants and study staff read HIVST results independently.

Summary of findings
99.1% (231/233) participants had a valid self-test result. Sensitivity and specificity of the self-test were 97.4% (CI: 87.93%-99.62%) and 100% (95% CI: 98.04-100%), respectively. 98.7% (230/233) participants interpreted their result correctly (1 of 44 positive results was interpreted as negative, 1 of 2 invalid results was interpreted as negative, and 1 negative result was interpreted as 'unsure of result'. 35.2% called the helpline for assistance during self-testing.

Acceptability
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
0.974

Specificity
n/a

Concordance
0.987

HIV positivity
19% (44/231)

Accuracy details
97.4% sensitivity and 100% specificity

Social harm
n/a

Linkage to prevention, care and treatment
97.8% understood next step of care as described in self-testing instructions. Next step of care for HIV-negative result: test again in three months; next step of care for HIV-positive result: go to a clinic for confirmation test and CD4 count.


Study status
Completed