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      Point-of-care HIV testing best practice for early infant diagnosis: an implementation study

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          Abstract

          Background

          With Universal Health Coverage and Integrated People-centred Health Care, streamlined health-systems and respectful care are necessary. South Africa has made great strides in prevention of mother-to-child transmission (PMTCT) but with the great burden of HIV, a minimum of birth and 10-week HIV-PCR testing are required for the estimated 360,000 HIV-exposed infants born annually which presents many challenges including delayed results and loss to follow-up. Point-of-care (POC) HIV testing of infants addresses these challenges well and facilitates initiation of HIV-infected infants rapidly after diagnosis for best clinical outcomes.

          Methods

          Objectives were to determine accuracy, feasibility and acceptability of POC testing compared to standard-of-care (SOC) central-laboratory testing. HIV-exposed infants for birth PCR testing in hospital ( n = 323) and follow-up at a primary health care clinic ( n = 117) in Durban, South Africa were included. A baseline situational-analysis reviewed registers and phoned mothers of HIV-exposed infants prior to the intervention. An effectiveness-implementation study of the Alere™q HIV-1/2 Detect POC test (heel-prick specimen processed in 50 min) was compared with SOC with questionnaires to mothers and staff. Stata 14 was used for analysis.

          Results

          At baseline 2% of birth HIV tests were missed; only 40% of mothers could be contacted; 17% did not receive birth test result; 19% did not have a 10-week test; 39% had not received the 10-week results. There were 5(1.5%) HIV-infected and 318(98.5%) HIV-negative infants detected in hospital with all clinic babies negative. All positive infants commenced ART before discharge. Ultimately POC and SOC had perfect concordance but for 10 SOC tests researchers actively tracked-down results or repeated tests. Turn around times for SOC tests were on average 8-days (IQR 6-10  days) and for POC testing was 0-days. The POC error-rate was 9,6% with all giving a result when repeated. The majority of mothers (92%) preferred POC testing with 7% having no preference. No staff preferred SOC testing with 79% preferring POC and 21% having no preference.

          Conclusions

          Point-of-care HIV testing for EID is accurate, feasible and acceptable, with benefits of early ART for all positive infants at birth facilities. We recommend that it be considered best practice for EID.

          Trial registration

          ISRCTN38911104 registered 9 January 2018 – retrospectively registered.

          Electronic supplementary material

          The online version of this article (10.1186/s12889-019-6990-z) contains supplementary material, which is available to authorized users.

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          Most cited references 46

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          "What they wanted was to give birth; nothing else": barriers to retention in option B+ HIV care among postpartum women in South Africa.

           Kate Clouse,  Sheree Schwartz,  Annelies van Rie … (2014)
          Women initiating antiretroviral therapy during pregnancy have high rates of dropout, particularly after delivery. We aimed to identify challenges to postpartum retention in care under Option B+, which expands antiretroviral therapy access to all HIV-positive pregnant women regardless of CD4 count.
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            Loss to follow-up before and after delivery among women testing HIV positive during pregnancy in Johannesburg, South Africa.

             Mhairi Maskew,  Annelies van Rie,  Bruce Larson … (2013)
            HIV-positive pregnant women are at heightened risk of becoming lost to follow-up (LTFU) from HIV care. We examined LTFU before and after delivery among pregnant women newly diagnosed with HIV. Observational cohort study of all pregnant women ≥18 years (N = 300) testing HIV positive for the first time at their first ANC visit between January and June 2010, at a primary healthcare clinic in Johannesburg, South Africa. Women (n = 27) whose delivery date could not be determined were excluded. Median (IQR) gestation at HIV testing was 26 weeks (21-30). Ninety-eight per cent received AZT prophylaxis, usually started at the first ANC visit. Of 139 (51.3%) patients who were ART eligible, 66.9% (95% CI 58.8-74.3%) initiated ART prior to delivery; median (IQR) ART duration pre-delivery was 9.5 weeks (5.1-14.2). Among ART-eligible patients, 40.5% (32.3-49.0%) were cumulatively retained through 6 months on ART. Of those ART-ineligible patients at HIV testing, only 22.6% (95% CI 15.9-30.6%) completed CD4 staging and returned for a repeat CD4 test after delivery. LTFU (≥1 month late for last scheduled visit) before delivery was 20.5% (95% CI 16.0-25.6%) and, among those still in care, 47.9% (95% CI 41.2-54.6%) within 6 months after delivery. Overall, 57.5% (95% CI 51.6-63.3%) were lost between HIV testing and 6 months post-delivery. Our findings highlight the challenge of continuity of care among HIV-positive pregnant women attending antenatal services, particularly those ineligible for ART. © 2013 Blackwell Publishing Ltd.
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              Implementing services for Early Infant Diagnosis (EID) of HIV: a comparative descriptive analysis of national programs in four countries

               Anirban Chatterjee,  Sangeeta Tripathi,  Robert Gass … (2011)
              Background There is a significant increase in survival for HIV-infected children who have early access to diagnosis and treatment. The goal of this multi-country review was to examine when and where HIV-exposed infants and children are being diagnosed, and whether the EID service is being maximally utilized to improve health outcomes for HIV-exposed children. Methods In four countries across Africa and Asia existing documents and data were reviewed and key informant interviews were conducted. EID testing data was gathered from the central testing laboratories and was then complemented by health facility level data extraction which took place using a standardized and validated questionnaire Results In the four countries reviewed from 2006 to 2009 EID sample volumes rose dramatically to an average of >100 samples per quarter in Cambodia and Senegal, >7,000 samples per quarter in Uganda, and >2,000 samples per quarter in Namibia. Geographic coverage of sites also rapidly expanded to 525 sites in Uganda, 205 in Namibia, 48 in Senegal, and 26 in Cambodia in 2009. However, only a small proportion of testing was done at lower-level health facilities: in Uganda Health Center IIs and IIIs comprised 47% of the EID collection sites, but only 11% of the total tests, and in Namibia 15% of EID sites collected >93% of all samples. In all countries except for Namibia, more than 50% of the EID testing was done after 2 months of age. Few sites had robust referral mechanisms between EID and ART. In a sub-sample of children, we noted significant attrition of infants along the continuum of care post testing. Only 22% (Senegal), 37% (Uganda), and 38% (Cambodia) of infants testing positive by PCR were subsequently initiated onto treatment. In Namibia, which had almost universal EID coverage, more than 70% of PCR-positive infants initiated ART in 2008. Conclusions While EID testing has expanded dramatically, a large proportion of PCR- positive infants are initiated on treatment. As EID services continue to scale-up, more programmatic attention and support is needed to retain HIV-exposed infants in care and ensure that those testing positive initiate treatment in a timely manner. Namibia's experience demonstrates that it is feasible for a rural, low-income country to achieve high national coverage of infant testing and treatment.
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                Author and article information

                Affiliations
                [1 ]ISNI 0000 0001 0723 4123, GRID grid.16463.36, Department of Paediatrics and Child Health, School of Clinical Medicine, , University of KwaZulu-Natal, ; Durban, South Africa
                [2 ]ISNI 0000 0004 0630 4574, GRID grid.416657.7, Department of Virology, Inkosi Albert Luthuli Central Hospital, National Health Laboratory Service, ; Durban, KwaZulu-Natal South Africa
                [3 ]ISNI 0000 0000 9155 0024, GRID grid.415021.3, South African Medical Research Council, Biostatistics Unit, ; Durban, South Africa
                [4 ]ISNI 0000 0000 9155 0024, GRID grid.415021.3, South African Medical Research Council, HIV Prevention Research Unit, ; Durban, South Africa
                [5 ]ISNI 0000 0001 0044 1330, GRID grid.413302.7, Department of Paediatrics, Addington Hospital, ; Durban, South Africa
                Contributors
                Elizabeth Spooner: ORCID: http://orcid.org/0000-0002-1498-8131, bethspoons@gmail.com
                Kerusha Govender: govenderk7@ukzn.ac.za
                Tarylee Reddy: tarylee.reddy@mrc.ac.za
                Gita Ramjee: gita.ramjee@mrc.ac.za
                Noxolo Mbadi: Nox.Mbadi@kznhealth.gov.za
                Swaran Singh: Swaran.Singh@kznhealth.gov.za
                Anna Coutsoudis: coutsoud@ukzn.ac.za
                Journal
                Journal ID (nlm-ta): BMC Public Health
                Journal ID (iso-abbrev): BMC Public Health
                Title: BMC Public Health
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2458
                Publication date (Electronic): 11 June 2019
                Publication date PMC-release 11 June 2019
                Publication date Collection 2019
                Volume: 19
                ID: 31185962 ID: 6560857 ID: 6990 ID: 10.1186/s12889-019-6990-z
                Copyright statement: © The Author(s). 2019

                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2019

                Link to data:

                ScienceOpen disciplines: Public health

                Keywords: early infant diagnosis (eid), pmtct, infant hiv, point-of-care (poc), maternal viral-load, alere™q hiv-1/2 detect

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