Explore the vast range of titles available.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic poses challenges to paediatric and adolescent HIV treatment programme. Modelling exercises raised concerns over potential impact of disruptions.ObjectivesTo describe the impact of the COVID-19 pandemic on viral load (VL) testing among infants, children and adolescents on antiretroviral treatment (ART) in Durban, South Africa.MethodRoutinely collected, aggregated data of monthly VL counts done on all those less than 19 years old from January 2018 to January 2022 was analysed. An interrupted time series analysis using a Prais-Winsten linear regression model, including terms for lockdowns and excess mortality determined VL trends.ResultsThe unadjusted mean VL was 2166 (confidence interval [CI]: 252.2) and 2016 (CI: 241.9), P = 0.039, and percentage VL suppression rates (72.9%, CI: 2.4% vs 73.6%, CI: 1.8%) across COVID and pre-COVID periods, showing no significant difference, P = 0.262. In the interrupted time series analysis, modelled monthly VL counts did not differ significantly by lockdown level (e.g., level 5 lockdown: –210.5 VLs, 95% CI: –483.0 to +62.1, P = 0.138) or excess mortality (–0.1, 95% CI: –6.3 to 6.1, P = 0.969). A significant downward trend in VL testing over time, including during the pre-COVID-19 period (–6.6 VL per month, 95% CI: –10.4 to –2.7, P = 0.002), was identified.ConclusionViral load suppression for children and adolescents were not negatively affected by COVID-19. A trend of decrease in VL testing predated COVID-19.What this study addsEvidence presented that HIV VL testing and suppression rates in children and adolescents in a high burden setting were sustained through the COVID pandemic.

Background Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Methods Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018–2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Results Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Conclusions Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation.

Background Viral suppression (VS) is a marker of effective HIV therapy, and viral load (VL) testing is critical for treatment monitoring, especially in high-risk groups such as children and pregnant/postpartum women. Although routine VL testing, via centralized laboratory networks, was implemented in Kenya starting in 2014, optimization and sustainable scale up of VL testing are still needed. Methods We conducted a mixed methods study to evaluate the impact of higher frequency, point-of-care (POC) VL testing in optimizing VS among children and pregnant/postpartum women on antiretroviral treatment (ART) in five HIV treatment facilities in western Kenya in the Opt4Kids and Opt4Mamas studies. We conducted 68 key informant interviews (KIIs) from December 2019 to December 2020 with children and pregnant women living with HIV, child caregivers, providers, laboratory/facility leadership, and county- or national-level policymakers. Our KII guide covered the following domains: (1) barriers and facilitators to ART use and VS, (2) literacy and experiences with VL in routine care and via study, and (3) opinions on how to scale up VL testing for optimal programmatic use. We used inductive coding and thematic analysis to identify dominant themes with convergent and divergent subthemes. Results Three main themes regarding VL testing emerged from our analysis. (1) Key informants uniformly contrasted POC VL testing’s faster results turnaround, higher accessibility, and likely cost-effectiveness against centralized VL testing. (2) Key informants also identified areas of improvement for POC VL testing in Kenya, such as quality control, human resource and infrastructure capacity, supply chain management, and integration of VL testing systems. (3) To enable successful scale-up of VL testing, key informants proposed expanding the POC VL testing scheme, electronic medical records systems, conducting quality checks locally, capacity building and developing strong partnerships between key stakeholders. Conclusion The more accessible, decentralized model of POC VL testing was deemed capable of overcoming critical challenges associated with centralized VL testing and was considered highly desirable for optimizing VS for children and pregnant/postpartum women living with HIV. While POC VL testing has the potential to improve VS rates among these populations, additional research is needed to develop strategies for ensuring the sustainability of POC VL testing programs. Trial registration NCT03820323, 29/01/2019

Introduction Monitoring HIV viral load (HVL) in people living with HIV (PLHIV) on antiretroviral therapy (ART) is recommended by the World Health Organization. Implementation of HVL testing programs have been affected by logistic and organizational challenges. Here we describe the HVL monitoring cascade in a rural setting in Tanzania and compare turnaround times (TAT) between an on-site and a referral laboratory. Methods In a nested study of the prospective Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) we included PLHIV aged ≥ 15 years, on ART for ≥ 6 months after implementation of routine HVL monitoring in 2017. We assessed proportions of PLHIV with a blood sample taken for HVL, whose results came back, and who were virally suppressed (HVL < 1000 copies/mL) or unsuppressed (HVL ≥ 1000 copies/mL). We described the proportion of PLHIV with unsuppressed HVL and adequate measures taken as per national guidelines and outcomes among those with low-level viremia (LLV; 100–999 copies/mL). We compare TAT between on-site and referral laboratories by Wilcoxon rank sum tests. Results From 2017 to 2020, among 4,454 PLHIV, 4,238 (95%) had a blood sample taken and 4,177 (99%) of those had a result. Of those, 3,683 (88%) were virally suppressed. In the 494 (12%) unsuppressed PLHIV, 425 (86%) had a follow-up HVL (102 (24%) within 4 months and 158 (37%) had virologic failure. Of these, 103 (65%) were already on second-line ART and 32/55 (58%) switched from first- to second-line ART after a median of 7.7 months (IQR 4.7–12.7). In the 371 (9%) PLHIV with LLV, 327 (88%) had a follow-up HVL. Of these, 267 (82%) resuppressed to < 100 copies/ml, 41 (13%) had persistent LLV and 19 (6%) had unsuppressed HVL. The median TAT for return of HVL results was 21 days (IQR 13–39) at the on-site versus 59 days (IQR 27–99) at the referral laboratory ( p  < 0.001) with PLHIV receiving the HVL results after a median of 91 days (IQR 36–94; similar for both laboratories). Conclusion Robust HVL monitoring is achievable in remote resource-limited settings. More focus is needed on care models for PLHIV with high viral loads to timely address results from routine HVL monitoring.

Background Pregnant women and children living with HIV in Kenya achieve viral suppression (VS) at lower rates than other adults. While many factors contribute to these low rates, the acquisition and development of HIV drug resistance mutations (DRMs) are a contributing factor. Recognizing the significance of DRMs in treatment decisions, resource-limited settings are scaling up national DRM testing programs. From provider and patient perspectives, however, optimal ways to operationalize and scale-up DRM testing in such settings remain unclear. Methods Our mixed methods study evaluates the attitudes towards, facilitators to, and barriers to DRM testing approaches among children and pregnant women on antiretroviral therapy (ART) in five HIV treatment facilities in Kenya. We conducted 68 key informant interviews (KIIs) from December 2019 to December 2020 with adolescents, caregivers, pregnant women newly initiating ART or with a high viral load, and providers, laboratory/facility leadership, and policy makers. Our KII guides covered the following domains: (1) DRM testing experiences in routine care and through our intervention and (2) barriers and facilitators to routine and point-of-care DRM testing scale-up. We used inductive coding and thematic analysis to identify dominant themes with convergent and divergent subthemes. Results The following themes emerged from our analysis: (1) DRM testing and counseling were valuable to clinical decision-making and reassuring to patients, with timely results allowing providers to change patient ART regimens faster; (2) providers and policymakers desired an amended and potentially decentralized DRM testing process that incorporates quicker sample-to-results turn-around-time, less burdensome procedures, and greater patient and provider “empowerment” to increase comfort with testing protocols; (3) facility-level delays, deriving from overworked facilities and sample tracking difficulties, were highlighted as areas for improvement. Conclusions DRM testing has the potential to considerably improve patient health outcomes. Key informants recognized several obstacles to implementation and desired a more simplified, time-efficient, and potentially decentralized DRM testing process that builds provider comfort and confidence with DRM testing protocols. Further investigating the implementation, endurance, and effectiveness of DRM testing training is critical to addressing the barriers and areas of improvement highlighted in our study. Trial Registration NCT03820323.

Background Since the scale-up of routine viral load (VL) testing started in 2016, there is limited evidence on VL suppression rates under programmatic settings and groups at risk of non-suppression. We conducted a study to estimate VL non-suppression (> 1000 copies/ml) and its risk factors using \"routine\" and \"repeat after enhanced adherence counselling (EAC)\" VL results. Methods We conducted an analytic cross-sectional study using secondary VL testing data collected between 2014 and 2018 from a centrally located laboratory. We analysed data from routine tests and repeat tests after an individual received EAC. Our outcome was viral load non-suppression. Bivariable and multivariable logistic regression was performed to identify factors associated with having VL non-suppression for routine and repeat VL. Results We analysed 103,609 VL test results (101,725 routine and 1884 repeat test results) collected from the country’s ten provinces. Of the 101,725 routine and 1884 repeat VL tests, 13.8% and 52.9% were non-suppressed, respectively. Only one in seven (1:7) of the non-suppressed routine VL tests had a repeat test after EAC. For routine VL tests; males (vs females, adjusted odds ratio (aOR) = 1.19, [95% CI 1.14–1.24]) and adolescents (10–19 years) (vs adults (25–49 years), aOR = 3.11, [95% CI 2.9–3.31]) were more at risk of VL non-suppression. The patients who received care at the secondary level (vs primary, aOR = 1.21, [95% CI 1.17–1.26]) and tertiary level (vs primary, aOR = 1.63, [95% CI 1.44–1.85]) had a higher risk of VL non-suppression compared to the primary level. Those that started ART in 2014–2015 (vs < 2010, aOR = 0.83, [95% CI 0.79–0.88]) and from 2016 onwards (vs < 2010, aOR = 0.84, [95% CI 0.79–0.89]) had a lower risk of VL non-suppression. For repeat VL tests; young adults (20–24 years) (vs adults (25–49 years), (aOR) = 3.48, [95% CI 2.16 -5.83]), adolescents (10–19 years) (vs adults (25–49 years), aOR = 2.76, [95% CI 2.11–3.72]) and children (0–9 years) (vs adults (25–49 years), aOR = 1.51, [95% CI 1.03–2.22]) were at risk of VL non-suppression. Conclusion Close to 90% suppression in routine VL shows that Zimbabwe is on track to reach the third UNAIDS target. Strategies to improve the identification of clients with high routine VL results for repeating testing after EAC and ART adherence in subpopulations (men, adolescents and young adolescents) at risk of viral non-suppression should be prioritised.

Human immunodeficiency virus (HIV) viral load (VL) monitoring was likely interrupted during the Coronavirus disease 2019 (COVID-19) pandemic. We used routine data on repeat VL testing among 667 prevention of vertical HIV transmission (PVT) clients in Ehlanzeni district, to determine compliance to VL testing recommendations and associated factors during different time periods: pre-COVID-19, transition, and COVID-19. Descriptive and multivariable Poisson regression analyses were conducted, with and without including revised PVT-guidelines rolled out in January-2020. Among 405 women with ≥ 2 VL tests, the overall median age was 30 years (interquartile range: 26–35 years). Compliance to recommended VL testing guidelines ranged between 81.5% (172/211) and 92.3% (191/207) at different time periods. Across all three periods and when revised PVT-guidelines were used, being compliant was significantly reduced among those with earliest VL = 50–999 copies/ml (incidence rate ratio (IRR) = 0.71 [95% confidence interval (CI) 0.61–0.82], p value < 0.001) and VL ≥ 1000 copies/ml (IRR = 0.18 [95% CI 0.09–0.36], p value < 0.001). When guideline revisions were excluded, compliance was only significantly reduced among those with VL ≥ 1000 copies/ml (IRR = 0.14 [95% CI 0.06–0.32], p value < 0.001) and increased during the COVID-19 period versus pre-COVID-19 (IRR = 1.10 [95% CI 1.05–1.15], p value < 0.001). Similar significant associations between compliance and VL level were observed when the COVID-19 period was analyzed separately. Significantly increased compliance to VL testing among the 25–34 years age-group versus younger women was also observed across all periods. These results highlight the importance of strengthening strategies such as short message service reminders and educational messaging, reaching all age-groups, to fast-track implementation targets for VL monitoring.

Background Providing viral load (VL) results to people living with HIV (PLHIV) on antiretroviral therapy (ART) remains a challenge in low and middle-income countries. Point-of-care (POC) VL testing could improve ART monitoring and the quality and efficiency of differentiated models of HIV care. We assessed the acceptability of POC VL testing within a differentiated care model that involved task-shifting from professional nurses to less highly-trained enrolled nurses, and an option of collecting treatment from a community-based ART delivery programme. Methods We undertook a qualitative sub-study amongst clients on ART and nurses within the STREAM study, a randomized controlled trial of POC VL testing and task-shifting in Durban, South Africa. Between March and August 2018, we conducted 33 semi-structured interviews with clients, professional and enrolled nurses and 4 focus group discussions with clients. Interviews and focus groups were audio recorded, transcribed, translated and thematically analysed. Results Amongst 55 clients on ART (median age 31, 56% women) and 8 nurses (median age 39, 75% women), POC VL testing and task-shifting to enrolled nurses was acceptable. Both clients and providers reported that POC VL testing yielded practical benefits for PLHIV by reducing the number of clinic visits, saving time, travel costs and days off work. Receiving same-day POC VL results encouraged adherence amongst clients, by enabling them to see immediately if they were ‘good’ or ‘bad’ adherers and enabled quick referrals to a community-based ART delivery programme for those with viral suppression. However, there was some concern regarding the impact of POC VL testing on clinic flows when implemented in busy public-sector clinics. Regarding task-shifting, nurses felt that, with extra training, enrolled nurses could help decongest healthcare facilities by quickly issuing ART to stable clients. Clients could not easily distinguish enrolled nurses from professional nurses, instead they highlighted the importance of friendliness, respect and good communication between clients and nurses. Conclusions POC VL testing combined with task-shifting was acceptable to clients and healthcare providers. Implementation of POC VL testing and task shifting within differentiated care models may help achieve international treatment targets. Trial registration NCT03066128 , registered 22/02/2017.

Background Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP). This report describes a randomized clinical trial sponsored by the Centers for Disease Control and Prevention (CDC): “Ending the HIV Epidemic Through Point-of-Care Technologies” (EHPOC). The study’s primary aim is to evaluate the use of a POC HIV VL test as part of a testing approach and assess the impact on time to linkage to ART or PrEP. The study will recruit people in Baltimore, Maryland, including patients attending a hospital emergency department, patients attending an infectious disease clinic, and people recruited via community outreach. The secondary aim is to evaluate the performance characteristics of two rapid HIV antibody tests approved by the United States Food and Drug Administration (FDA). Methods The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) HIV screening tests. Intervention arm participants will receive a POC HIV VL test in addition to the SOC HIV diagnostic screening tests. Follow up will consist of an interim phone survey conducted at week-4 and an in-person week-12 visit. Demographic and behavioral information, and oral fluid and blood specimens will be collected at enrollment and at week-12. Survey data will be captured in a Research Electronic Data Capture (REDCap) database. Participants in both arms will be referred for either ART or PrEP based on their HIV test results. Discussion The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations. Trial registration NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021.

Background Uganda adapted Viral load (VL) testing for monitoring HIV treatment success and virologic failure. However, there is a paucity of data on how the VL testing guidelines are followed in practice in the HIV clinics. This study determined the adherence to national guidelines on VL testing, barriers, and associated factors in persons living with HIV (PLHIV) on ART in southwestern Uganda.  Methods We conducted a cross-sectional mixed methods study from April to May 2021 at four HIV clinics in southwestern Uganda. Patient chart review using a checklist that captured age, gender, and level of a healthcare facility, dates of ART initiation, dates VL specimens were drawn, line of ART, patient adherence to ART was done. Continuous data were summarized using mean and median and Chi-square was used for categorical data. We performed regression analysis to determine factors associated with adherence to viral load testing guidelines at a 95% level of significance. Key informant interviews with managers of the health facility, ART clinic and laboratory were carried out, and thematic analysis was conducted to explore barriers to adherence to VL testing guidelines. Results The participants’ mean (SD) age was 39.9(± 13.1) years, 39.5% were male, 45.8% received care at a general hospital and median duration on ART was 5 years (IQR;3–7). Of the 395 patient charts reviewed, 317 had their VL testing (80.3%) per the guidelines (defined as up to one month post due date). Receiving care at a hospital (aOR = 2.20; 95%CI 1.30–3.70; p  = 0.002) and increasing patient age (aOR = 1.02; 95%CI 1.02–1.06; p  = 0.020) were the factors associated with adhering to VL testing guidelines. Long turnaround time of VL results and insufficient VL testing kits were cites by providers as barriers. Conclusion We found suboptimal adherence to VL testing guidelines in PLHIV on ART in southwestern Uganda. Increasing patient age and getting care at a higher-level health facility were associated with guideline-based viral VL testing. Long turnaround time of VL test results and inadequate test kits hindered compliance to VL monitoring guidelines. Strategies that target young PLHIV and lower-level health facilities, increase the stock of consumables and shorten VL results turnaround time are needed to improve adherence to VL testing guidelines.