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Supervised oral HIV self-testing is accurate in rural KwaZulu-Natal, South Africa.
Trop Med Int Health. 2016 06; 21(6):759-67.TM

Abstract

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.

Authors+Show Affiliations

Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.Médecins Sans Frontières, Eshowe Project, KwaZulu Natal, South Africa.Médecins Sans Frontières, South Africa Mission, Cape Town, South Africa.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

27098272

Citation

Martínez Pérez, Guillermo, et al. "Supervised Oral HIV Self-testing Is Accurate in Rural KwaZulu-Natal, South Africa." Tropical Medicine & International Health : TM & IH, vol. 21, no. 6, 2016, pp. 759-67.
Martínez Pérez G, Steele SJ, Govender I, et al. Supervised oral HIV self-testing is accurate in rural KwaZulu-Natal, South Africa. Trop Med Int Health. 2016;21(6):759-67.
Martínez Pérez, G., Steele, S. J., Govender, I., Arellano, G., Mkwamba, A., Hadebe, M., & van Cutsem, G. (2016). Supervised oral HIV self-testing is accurate in rural KwaZulu-Natal, South Africa. Tropical Medicine & International Health : TM & IH, 21(6), 759-67. https://doi.org/10.1111/tmi.12703
Martínez Pérez G, et al. Supervised Oral HIV Self-testing Is Accurate in Rural KwaZulu-Natal, South Africa. Trop Med Int Health. 2016;21(6):759-67. PubMed PMID: 27098272.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Supervised oral HIV self-testing is accurate in rural KwaZulu-Natal, South Africa. AU - Martínez Pérez,Guillermo, AU - Steele,Sarah J, AU - Govender,Indira, AU - Arellano,Gemma, AU - Mkwamba,Alec, AU - Hadebe,Menzi, AU - van Cutsem,Gilles, Y1 - 2016/05/11/ PY - 2016/4/22/entrez PY - 2016/4/22/pubmed PY - 2017/7/1/medline KW - Afrique du Sud KW - HIV testing KW - HIV/AIDS KW - South Africa KW - Sudáfrica KW - VIH/SIDA KW - auto-dépistage du VIH par voie orale KW - autoprueba oral del VIH KW - dépistage du VIH KW - oral HIV self-testing KW - prueba para VIH KW - sensibilidad y especificidad KW - sensibilité et spécificité KW - sensitivity and specificity SP - 759 EP - 67 JF - Tropical medicine & international health : TM & IH JO - Trop. Med. Int. Health VL - 21 IS - 6 N2 - 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. SN - 1365-3156 UR - https://www.unboundmedicine.com/medline/citation/27098272/Supervised_oral_HIV_self_testing_is_accurate_in_rural_KwaZulu_Natal_South_Africa_ L2 - https://doi.org/10.1111/tmi.12703 DB - PRIME DP - Unbound Medicine ER -