Supervised oral HIV self-testing is accurate in rural KwaZulu-Natal, South Africa.

OBJECTIVES To achieve UNAIDS 90-90-90 targets, alternatives to conventional HIV testing models are necessary in South Africa to increase population awareness of their HIV status. One of the alternatives is oral mucosal transudates-based HIV self-testing (OralST). This study describes implementation of counsellor-introduced supervised OralST in a high HIV prevalent rural area. METHODS Cross-sectional study conducted in two government-run primary healthcare clinics and three Médecins Sans Frontières-run fixed-testing sites in uMlalazi municipality, KwaZulu-Natal. Lay counsellors sampled and recruited eligible participants, sought informed consent and demonstrated the use of the OraQuick(™) OralST. The participants used the OraQuick(™) in front of the counsellor and underwent a blood-based Determine(™) and a Unigold(™) rapid diagnostic test as gold standard for comparison. Primary outcomes were user error rates, inter-rater agreement, sensitivity, specificity and predictive values. RESULTS A total of 2198 participants used the OraQuick(™) , of which 1005 were recruited at the primary healthcare clinics. Of the total, 1457 (66.3%) were women. Only two participants had to repeat their OraQuick(™) . Inter-rater agreement was 99.8% (Kappa 0.9925). Sensitivity for the OralST was 98.7% (95% CI 96.8-99.6), and specificity was 100% (95% CI 99.8-100). CONCLUSION This study demonstrates high inter-rater agreement, and high accuracy of supervised OralST. OralST has the potential to increase uptake of HIV testing and could be offered at clinics and community testing sites in rural South Africa. Further research is necessary on the potential of unsupervised OralST to increase HIV status awareness and linkage to care.