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



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.



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).



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.
Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.
Guillermo
G
Martínez Pérez
Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.
Sarah J
SJ
Steele
Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.
Indira
I
Govender
Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.
Gemma
G
Arellano
Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.
Alec
A
Mkwamba
Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.
Menzi
M
Hadebe
Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.
Gilles
G
van Cutsem
D015492:AIDS Serodiagnosis / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000554:Ambulatory Care Facilities; D000906:Antibodies / Q000378:metabolism; D001364:Awareness; D003430:Cross-Sectional Studies; D059026:Diagnostic Self Evaluation; D005260:Female; D006678:HIV; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009061:Mouth Mucosa / Q000276:immunology*; D011320:Primary Health Care; D015203:Reproducibility of Results; D012424:Rural Population; D012648:Self Care / Q000379:methods*; D013019:South Africa; D055815:Young Adult
D000906:Antibodies
Afrique du Sud; HIV testing; HIV/AIDS; South Africa; Sudáfrica; VIH/SIDA; auto-dépistage du VIH par voie orale; autoprueba oral del VIH; dépistage du VIH; oral HIV self-testing; prueba para VIH; sensibilidad y especificidad; sensibilité et spécificité; sensitivity and specificity