Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial

Drain, Paul K.; Dorward, Jienchi; Violette, Lauren R; Quame-Amaglo, Justice; Thomas, Katherine K.; Samsunder, Natasha; Ngobese, Hope; Mlisana, Koleka; Moodley, Pravi; Donnell, Deborah; Barnabas, Ruanne V.; Naidoo, Kogieleum; Karim, Salim Safurdeen. Abdool; Celum, Connie; Garrett, Nigel

doi:10.1016/s2352-3018(19)30402-3

Cited by 90 publications

(103 citation statements)

References 18 publications

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“…Its use was recently shown to increase viral suppression and retention in community-based care in South Africa. 27 Patients identified as having ART failure will need switching to alternative regimens with adherence support, to prevent mortality. Screening and empirical treatment for opportunistic infections is also recommended by WHO advanced HIV guidelines.…”

Section: Discussionmentioning

confidence: 99%

Virological failure, HIV-1 drug resistance, and early mortality in adults admitted to hospital in Malawi: an observational cohort study

et al. 2020

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Summary Background Antiretroviral therapy (ART) scale-up in sub-Saharan Africa combined with weak routine virological monitoring has driven increasing HIV drug resistance. We investigated ART failure, drug resistance, and early mortality among patients with HIV admitted to hospital in Malawi. Methods This observational cohort study was nested within the rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalised patients in Africa (STAMP) trial, which recruited unselected (ie, irrespective of clinical presentation) adult (aged ≥18 years) patients with HIV-1 at admission to medical wards. Patients were included in our observational cohort study if they were enrolled at the Malawi site (Zomba Central Hospital) and were taking ART for at least 6 months at admission. Patients who met inclusion criteria had frozen plasma samples tested for HIV-1 viral load. Those with HIV-1 RNA of at least 1000 copies per mL had drug resistance testing by ultra-deep sequencing, with drug resistance defined as intermediate or high-level resistance using the Stanford HIVDR program. Mortality risk was calculated 56 days from enrolment. Patients were censored at death, at 56 days, or at last contact if lost to follow-up. The modelling strategy addressed the causal association between HIV multidrug resistance and mortality, excluding factors on the causal pathway (most notably, CD4 cell count, clinical signs of advanced HIV, and poor functional and nutritional status). Findings Of 1316 patients with HIV enrolled in the STAMP trial at the Malawi site between Oct 26, 2015, and Sept 19, 2017, 786 had taken ART for at least 6 months. 252 (32%) of 786 patients had virological failure (viral load ≥1000 copies per mL). Mean age was 41·5 years (SD 11·4) and 528 (67%) of 786 were women. Of 237 patients with HIV drug resistance results available, 195 (82%) had resistance to lamivudine, 128 (54%) to tenofovir, and 219 (92%) to efavirenz. Resistance to at least two drugs was common (196, 83%), and this was associated with increased mortality (adjusted hazard ratio 1·7, 95% CI 1·2–2·4; p=0·0042). Interpretation Interventions are urgently needed and should target ART clinic, hospital, and post-hospital care, including differentiated care focusing on patients with advanced HIV, rapid viral load testing, and routine access to drug resistance testing. Prompt diagnosis and switching to alternative ART could reduce early mortality among inpatients with HIV. Funding Joint Global Health Trials Scheme of the Medical Research Council, UK Department for International Development, and Wellcome Trust.

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Section: Discussionmentioning

confidence: 99%

Virological failure, HIV-1 drug resistance, and early mortality in adults admitted to hospital in Malawi: an observational cohort study

et al. 2020

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“…Inadequate training, lack of knowledge, poor record-keeping, and difficulties with transportation of samples to the central laboratory are barriers to scale-up of VL testing and may have contributed to the non-uptake of VL testing we observed [17,26]. Strategies to improve uptake of VL testing including point-of-care testing [28], identifying VL focal persons to flag those in need of VL testing, enhanced adherence counseling, patient education, and demand creation for VL testing, are needed to improve coverage of viral suppression and HIV epidemic control in resource-limited settings [29]. A VL champion program increased testing uptake in South Africa from 64 to 90% after 6 months [24].…”

Section: Discussionmentioning

confidence: 99%

Non-uptake of viral load testing among people receiving HIV treatment in Gomba district, rural Uganda

et al. 2020

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Background Viral load (VL) testing is the gold-standard approach for monitoring human immunodeficiency virus (HIV) treatment success and virologic failure, but uptake is suboptimal in resource-limited and rural settings. We conducted a cross-sectional study of risk factors for non-uptake of VL testing in rural Uganda. Methods We conducted a cross-sectional analysis of uptake of VL testing among randomly selected people with HIV (PWH) receiving anti-retroviral treatment (ART) for at least 6 months at all eight primary health centers in Gomba district, rural Uganda. Socio-demographic and clinical data were extracted from medical records for the period January to December 2017. VL testing was routinely performed 6 months after ART initiation and 12 months thereafter for PWH stable on ART. We used descriptive statistics and multivariable logistic regression to evaluate factors associated with non-uptake of VL testing (the primary outcome). Results Of 414 PWH, 60% were female, and the median age was 40 years (interquartile range [IQR] 31–48). Most (62.3%) had been on ART > 2 years, and the median duration of treatment was 34 months (IQR 14–55). Thirty three percent did not receive VL testing: 36% of women and 30% of men. Shorter duration of ART (≤2 years) (adjusted odds ratio [AOR] 2.38; 95% CI:1.37–4.12; p = 0.002), younger age 16–30 years (AOR 2.74; 95% CI:1.44–5.24; p = 0.002) and 31–45 years (AOR 1.92; 95% CI 1.12–3.27; p = 0.017), and receipt of ART at Health Center IV (AOR 2.85; 95% CI: 1.78–4.56; p < 0.001) were significantly associated with non-uptake of VL testing. Conclusions One-in-three PWH on ART missed VL testing in rural Uganda. Strategies to improve coverage of VL testing, such as VL focal persons to flag missed tests, patient education and demand creation for VL testing are needed, particularly for recent ART initiates and younger persons on treatment, in order to attain the third Joint United Nations Program on HIV/AIDS (UNAIDS) 95–95-95 target – virologic suppression for 95% of PWH on ART.

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“…POC VL testing improves turn‐around time (TATs) and retention in care among adults on ART [8], while POC EID testing reduces TATs and time to ART initiation in infants [9‐14]. Both have potential to reduce morbidity and mortality among pregnant WLHIV and their infants.…”

Section: Introductionmentioning

confidence: 99%

Point‐of‐care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn‐around times

et al. 2020

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Introduction: Maternal viral load monitoring (mVL) and early infant diagnosis (EID) are necessary to achieve elimination of mother-to-child transmission of HIV. Point-of-care testing can achieve better outcomes compared to centralized laboratory testing (CLT). We describe the first implementation of point-of-care (POC) mVL and EID testing around delivery at four high volume tertiary obstetric units (TOUs) in Gauteng, South Africa. Methods: Prospective study of pregnant women living with HIV (WLHIV) and their infants. During the period 1 June 2018 to 31 March 2019, routine staff collected blood specimens from women and their infants around delivery. Specimen collection occurred throughout the week while dedicated POC operators, conducted testing during working hours on weekdays. Descriptive statistics and multivariable Poisson regression with robust error variance were used to describe outcomes and associated factors. Outcomes determined were (i) coverage of mVL and EID testing defined as a proportion of live births to WLHIV admitted at each facility (ii) results returned prior to discharge (iii) turn-around time (TAT) and iv) performance of POC testing compared to CLT. Results: In total, 8147 live births to pregnant WLHIV were recorded in the implementation period. Of these, 2912 mVL and 5074 EID specimens were included in the analysis, with 131 (4.5%) mVL and 715 (14.1%) EID specimens having initial invalid/ error results. Overall coverage of POC mVL and EID testing was 35.6% (range 20.9% to 60.1%) and 61.9% (range 47.0% to 88.0%) respectively. Proportions of POC tested mothers and infants with results returned prior to discharge were 74.3% (range 39.0% to 95.7%) and 73.0% (range 50.0 to 97.9%). Return of results was independently associated with TOU, afterhours specimen collection, having an initial invalid or error result and period of implementation. Overall TAT for specimens collected from mother-infant pairs where both had POC testing, during weekdays was longer for EID compared to mVL testing (median 3.3 hours vs. 2.9 hours, p-value sign test <0.001). POC results were comparable to those from laboratory testing. Conclusion: Accurate and timely POC mVL and EID testing around delivery was implemented with variable success across TOUs. Further scale up would need to address health system factors at facility level and high analytical error rates.

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Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial

Cited by 90 publications

References 18 publications

Virological failure, HIV-1 drug resistance, and early mortality in adults admitted to hospital in Malawi: an observational cohort study

Virological failure, HIV-1 drug resistance, and early mortality in adults admitted to hospital in Malawi: an observational cohort study

Non-uptake of viral load testing among people receiving HIV treatment in Gomba district, rural Uganda

Point‐of‐care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn‐around times

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