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

Peter Bock, Comfort Phiri, Estelle Piwowar-Manning, Barry Kosloff, Nomtha Mandla, Alicia Young, Anelet James, Ab Schaap, Michelle Scheepers, Deborah Donnell, Sam Griffith, Wafaa El-Sadr, Kwame Shanaube, Nulda Beyers, Richard Hayes, Sarah Fidler, Helen Ayles, HPTN 071 (PopART) Study Team, Peter Bock, Comfort Phiri, Estelle Piwowar-Manning, Barry Kosloff, Nomtha Mandla, Alicia Young, Anelet James, Ab Schaap, Michelle Scheepers, Deborah Donnell, Sam Griffith, Wafaa El-Sadr, Kwame Shanaube, Nulda Beyers, Richard Hayes, Sarah Fidler, Helen Ayles, HPTN 071 (PopART) Study Team

Abstract

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. HIV-POCT 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 HIV-POCT 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 HIV-POCT 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.

Keywords: HIV rapid test; HPTN 071 (PopART); community; household; quality control; sensitivity.

Conflict of interest statement

No authors declare a conflict of interests.

Figures

Figure 1.
Figure 1.
Sensitivity of HIV-POCT in Zambia and South Africa by quarter. HIV-POCT: HIV point-of-care testing.
Figure 2a.
Figure 2a.
Flow chart of follow up of participants with discrepant HIV results South Africa. HIV-POCT: HIV point-of-care testing. HIV-POCT−: original HIV-POCT algorithm negative; HIV-POCT+: original HIV-POCT algorithm positive; inconclusive HIV-POCT−: original HIV-POCT algorithm discordant; GS+: laboratory algorithm (gold standard) HIV positive; GS−: laboratory algorithm negative; GS confirmed: after retesting the HIV-POCT agreed with the laboratory gold standard; HIV-POCT confirmed: after retesting the results of the repeat HIV-POCT algorithm agreed with the original HIV-POCT algorithm.
Figure 2b.
Figure 2b.
Flow chart of follow up of participants with discrepant HIV results Zambia.

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