Understanding low sensitivity of community-based HIV rapid testing : experiences from the HPTN 071 (PopART) trial in Zambia and South Africa

Bock, Peter ; Phiri, Comfort ; Piwowar-Manning, Estelle ; Kosloff, Barry ; Mandla, Nomtha ; Young, Alicia ; James, Anelet ; Schaap, A. b. ; Scheepers, Michelle ; Donnell, Deborah ; Griffith, Sam ; El-Sadr, Wafaa ; Shanaube, Kwame ; Beyers, Nulda ; Hayes, Richard ; Fidler, Sarah ; Ayles, Helen (2017-08-27)

CITATION: Bock, P., et al. 2017. Understanding low sensitivity of community-based HIV rapid testing : experiences from the HPTN 071 (PopART) trial in Zambia and South Africa. Journal of the International AIDS Society, 20(S6):21780, doi:10.7448/IAS.20.7.21780.

The original publication is available at https://onlinelibrary.wiley.com

Article

Introduction: Population-wide HIV testing services (HTS) must be delivered in order to achieve universal antiretroviral treatment (ART) coverage. To accurately deliver HTS at such scale, non-facility-based HIV point-of-care testing (HIV-POCT) is necessary but requires rigorous quality assurance (QA). This study assessed the performance of community-wide HTS in Zambia and South Africa (SA) as part of the HPTN 071 (PopART) study and explores the impact of quality improvement interventions on HTS performance. Methods: Between 2014 and 2016, HIV-POCT was undertaken within households both as part of the randomly selected HPTN 071 research cohort (Population Cohort [PC]) and as part of the intervention provided by community HIV-care providers. HIVPOCT followed national algorithms in both countries. Consenting PC participants provided a venous blood sample in addition to being offered HIV-POCT. We compared results obtained in the PC using a laboratory-based gold standard (GS) testing algorithm and HIV-POCT. Comprehensive QA mechanisms were put in place to support the community-wide testing. Participants who were identified as having a false negative or false positive HIV rapid test were revisited and offered retesting. Results: We initially observed poor sensitivity (45–54%, 95% confidence interval [CI] 31–69) of HIV-POCT in the PC in SA compared to sensitivity in Zambia for the same time period of 95.8% (95% CI 93–98). In both countries, specificity of HIVPOCT was >98%. With enhanced QA interventions and adoption of the same HIV-POCT algorithm, sensitivity in SA improved to a similar level as in Zambia. Conclusions: This is one of the first reports of HIV-POCT performance during wide-scale delivery of HTS compared to a GS laboratory algorithm. HIV-POCT in a real-world setting had a lower sensitivity than anticipated. Appropriate choice of HIVPOCT algorithms, intensive training and supervision, and robust QA mechanisms are necessary to optimize HIV-POCT test performance when testing is delivered at a community level. HIV-POCT in clients who did not disclose that they were on ART may have contributed to false negative HIV-POCT results and should be the topic of future research.

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