Progress in scale up of HIV viral load testing in select sub-Saharan African countries 2016-2018.

Introduction: We assessed progress in HIV viral load (VL) scale up across seven sub-Saharan African (SSA) countries and discussed challenges and strategies for improving VL coverage among patients on anti-retroviral therapy (ART).

Methods: A retrospective review of VL testing was conducted in Côte d'Ivoire, Kenya, Lesotho, Malawi, Namibia, Tanzania, and Uganda from January 2016 through June 2018. Data were collected and included the cumulative number of ART patients, number of patients with ≥ 1 VL test result (within the preceding 12 months), the percent of VL test results indicating viral suppression, and the mean turnaround time for VL testing.

Contribution of PEPFAR-Supported HIV and TB Molecular Diagnostic Networks to COVID-19 Testing Preparedness in 16 Countries.

The US President's Emergency Plan for AIDS Relief (PEPFAR) supports molecular HIV and tuberculosis diagnostic networks and information management systems in low- and middle-income countries. We describe how national programs leveraged these PEPFAR-supported laboratory resources for SARS-CoV-2 testing during the COVID-19 pandemic. We sent a spreadsheet template consisting of 46 indicators for assessing the use of PEPFAR-supported diagnostic networks for COVID-19 pandemic response activities during April 1, 2020, to March 31, 2021, to 27 PEPFAR-supported countries or regions.

Protecting the gains: analysis of HIV treatment and service delivery programme data and interventions implemented in 19 African countries during COVID-19.

Introduction: The potential disruption in antiretroviral therapy (ART) services in Africa at the start of the COVID-19 pandemic raised concern for increased morbidity and mortality among people living with HIV (PLHIV). We describe HIV treatment trends before and during the pandemic and interventions implemented to mitigate COVID-19 impact among countries supported by the US Centers for Disease Control and Prevention (CDC) through the President's Emergency Plan for AIDS Relief (PEPFAR).

Methods: We analysed quantitative and qualitative data reported by 10,387 PEPFAR-CDC-supported ART sites in 19 African countries between October 2019 and March 2021.

The performance of using dried blood spot specimens for HIV-1 viral load testing: A systematic review and meta-analysis.

Background: Accurate routine HIV viral load testing is essential for assessing the efficacy of antiretroviral treatment (ART) regimens and the emergence of drug resistance. While the use of plasma specimens is the standard for viral load testing, its use is restricted by the limited ambient temperature stability of viral load biomarkers in whole blood and plasma during storage and transportation and the limited cold chain available between many health care facilities in resource-limited settings. Alternative specimen types and technologies, such as dried blood spots, may address these issues and increase access to viral load testing; however, their technical performance is unclear.

A Partially Multiplexed HIV Drug Resistance (HIVDR) Assay for Monitoring HIVDR Mutations of the Protease, Reverse-Transcriptase (PRRT), and Integrase (INT).

As dolutegravir (DTG)-containing HIV regimens are scaled up globally, monitoring for HIV drug resistance (HIVDR) will become increasingly important. We designed a partially multiplexed HIVDR assay using Sanger sequencing technology to monitor HIVDR mutations in the protease, reverse-transcriptase (PRRT), and integrase (INT). A total of 213 clinical and analytical plasma and dried blood spot (DBS) samples were used in the evaluation.

High Level of HIV Drug Resistance and Virologic Nonsuppression Among Female Sex Workers in Ethiopia: A Nationwide Cross-Sectional Study.

Objective: To determine viral load (VL) nonsuppression (VLN) rates, HIV drug resistance (HIVDR) prevalence, and associated factors among female sex workers (FSWs) in Ethiopia.

Methods: A cross-sectional biobehavioral survey was conducted among FSWs in 11 cities in Ethiopia in 2014. Whole blood was collected, and HIVDR genotyping was performed.

Diagnostic Accuracy of Dried Plasma Spot Specimens for HIV-1 Viral Load Testing: A Systematic Review and Meta-analysis.

Background: Dried plasma spot specimens may be a viable alternative to traditional liquid plasma in field settings, but the diagnostic accuracy is not well understood.

Methods: Standard databases (PubMed and Medline), conferences, and gray literature were searched until January 2019. The quality of evidence was evaluated using the Standards for Reporting Studies of Diagnostic Accuracy and Quality Assessment of Diagnostic Accuracy Studies-2 criteria.

HIV Viral Load Monitoring Among Patients Receiving Antiretroviral Therapy - Eight Sub-Saharan Africa Countries, 2013-2018.

One component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) goal to end the HIV/AIDS epidemic by 2030, is that 95% of all persons receiving antiretroviral therapy (ART) achieve viral suppression. Thus, testing all HIV-positive persons for viral load (number of copies of viral RNA per mL) is a global health priority (1). CDC and other U.

High Coverage of Antiretroviral Treatment With Annual Home-Based HIV Testing, Follow-up Linkage Services, and Implementation of Test and Start: Findings From the Chókwè Health Demographic Surveillance System, Mozambique, 2014-2019.

Background: Early antiretroviral therapy (ART) is necessary for HIV epidemic control and depends on early diagnosis and successful linkage to care. Since 2014, annual household-based HIV testing and counseling and linkage services have been provided through the Chókwè Health and Demographic Surveillance System for residents testing HIV positive in this high HIV-burden district.

Methods: District-wide Test and Start [T&S, ART for all people living with HIV (PLHIV)] began in August 2016, supported by systematic interventions to improve linkage to care and treatment.

Drug Resistance Mutations Among South African Children Living With HIV on WHO-recommended ART Regimens.

Background: Children living with human immunodeficiency virus (HIV) (CLHIV) receiving antiretroviral therapy (ART) in resource-limited settings are susceptible to high rates of acquired HIV drug resistance (HIVDR), but few studies include children initiating age-appropriate World Health Organization (WHO)-recommended first-line regimens. We report data from a cohort of ART-naive South African children who initiated first-line ART.

Methods: ART-eligible CLHIV aged 0-12 years were enrolled from 2012 to 2014 at 5 public South African facilities and were followed for up to 24 months.

Building and Sustaining Optimized Diagnostic Networks to Scale-up HIV Viral Load and Early Infant Diagnosis.

Background: Progress toward meeting the UNAIDS 2014 HIV treatment (90-90-90) targets has been slow in some countries because of gaps in access to HIV diagnostic tests. Emerging point-of-care (POC) molecular diagnostic technologies for HIV viral load (VL) and early infant diagnosis (EID) may help reduce diagnostic gaps. However, these technologies need to be implemented in a complementary and strategic manner with laboratory-based instruments to ensure optimization.

Clinical/Laboratory Interface Interventions to Improve Impact of Viral Load and Early Infant Diagnosis Testing Scale-Up.

Despite tremendous improvements in viral load (VL) monitoring and early infant diagnosis (EID) in many countries, low VL and EID testing rates and low VL suppression rates persist in specific regions and among certain subpopulations. The VL/EID cascade includes patient and provider demand creation, sample collection and transportation, laboratory testing, results transmission back to the clinic, and patient management. Gaps in communication and coordination between clinical and laboratory counterparts can lead to suboptimal outcomes, such as delay or inability to collect and transport samples to the laboratory for testing and failure of test results to reach providers and patients in an efficient, timely, and effective manner.

Use of viral load to improve survey estimates of known HIV-positive status and antiretroviral treatment coverage.

Objective: To compare alternative methods of adjusting self-reported knowledge of HIV-positive status and antiretroviral (ARV) therapy use based on undetectable viral load (UVL) and ARV detection in blood.

Design: Post hoc analysis of nationally representative household survey to compare alternative biomarker-based adjustments to population HIV indicators.

Methods: We reclassified HIV-positive participants aged 15-64 years in the 2012 Kenya AIDS Indicator Survey (KAIS) who were unaware of their HIV-positive status by self-report as aware and on antiretroviral treatment if either ARVs were detected or viral load was undetectable (<550 copies/ml) on dried blood spots.

Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis.

Background: Access to point-of-care HIV testing shortens turn-around times, time to diagnosis and reduces loss to follow-up hence minimizing barriers to early linkage to care and treatment among HIV infected infants. Currently samples for early infant HIV diagnosis are sent to centralized testing facilities which are few and located only at specific regions in Kenya. However, there are Point of Care (POC) early infant diagnosis [EID] technologies elsewhere such as SAMBA and ALERE-Q that are yet to be evaluated in Kenya despite the urgent need for data to inform policy formulation regarding EID.

Adverse fetal and infant outcomes among HIV-infected women who received either nonnucleoside reverse transcriptase inhibitor-based or protease inhibitor-based antiretroviral therapy for prevention of mother-to-child transmission.

Background: For HIV-infected pregnant and breastfeeding women, antiretroviral therapy (ART) is known to reduce the mother's risk of passing the infection to her child. However, concerns remain about possible associations between various components of different ART regimens and adverse fetal and infant outcomes. As part of a clinical trial in western Kenya for the prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women received one of two different ART regimens.

Laboratory medicine in Africa since 2008: then, now, and the future.

The Maputo Declaration of 2008 advocated for commitment from global stakeholders and national governments to prioritise support and harmonisation of laboratory systems through development of comprehensive national laboratory strategies and policies in sub-Saharan Africa. As a result, HIV laboratory medicine in Africa has undergone a transformation, and substantial improvements have been made in diagnostic services, networks, and institutions, including the development of a competent workforce, introduction of point-of-care diagnostics, and innovative quality improvement programmes that saw more than 1100 laboratories enrolled and 44 accredited to international standards. These improved HIV laboratories can now be used to combat emerging continental and global health threats in the decades to come.

CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto System.

Background: The BD FACSPresto system uses capillary and venous blood to measure CD4 absolute counts (CD4), %CD4 in lymphocytes, and hemoglobin (Hb) in approximately 25 minutes. CD4 cell count is used with portable CD4 counters in resource-limited settings to manage HIV/AIDS patients. A method comparison was performed using capillary and venous samples from seven clinical laboratories in five countries.

Scaling up HIV viral load - lessons from the large-scale implementation of HIV early infant diagnosis and CD4 testing.

Introduction: The scale-up of effective HIV viral load (VL) testing is an urgent public health priority. Implementation of testing is supported by the availability of accurate, nucleic acid based laboratory and point-of-care (POC) VL technologies and strong WHO guidance recommending routine testing to identify treatment failure. However, test implementation faces challenges related to the developing health systems in many low-resource countries.

Evaluation of the performance of Abbott m2000 and Roche COBAS Ampliprep/COBAS Taqman assays for HIV-1 viral load determination using dried blood spots and dried plasma spots in Kenya.

Background: Routine HIV viral load testing is not widely accessible in most resource-limited settings, including Kenya. To increase access to viral load testing, alternative sample types like dried blood spots (DBS), which overcome the logistic barriers associated with plasma separation and cold chain shipment need to be considered and evaluated. The current study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 (Abbott) and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load assays in western Kenya.

Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya.

Background: Herpes simplex virus type 2 (HSV-2) infections are associated with increased risk of HIV transmission. We determined HSV-2 prevalence, incidence and associated risk factors, incidence among persons with indeterminate results, and prevalence of HSV-2/HIV co-infection among young adults (18-34 years) and adolescents (16-17 years) enrolled in an HIV incidence cohort study in western Kenya.

Methods: Participants (n = 1106; 846 adults) were screened and those HIV-1 negative were enrolled and followed-up quarterly for one year.

Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial.

Background: HIV disease staging with referral laboratory-based CD4 cell count testing is a key barrier to the initiation of antiretroviral treatment (ART). Point-of-care CD4 cell counts can improve linkage to HIV care among people living with HIV, but its effect has not been assessed with a randomised controlled trial in the context of home-based HIV counselling and testing (HBCT).

Methods: We did a two-arm, cluster-randomised, controlled efficacy trial in two districts of western Kenya with ongoing HBCT.

Low levels of viral suppression among refugees and host nationals accessing antiretroviral therapy in a Kenyan refugee camp.

Background: Refugees and host nationals who accessed antiretroviral therapy (ART) in a remote refugee camp in Kakuma, Kenya (2011-2013) were compared on outcome measures that included viral suppression and adherence to ART.

Methods: This study used a repeated cross-sectional design ( and ). All adults (≥18 years) receiving care from the refugee camp clinic and taking antiretroviral therapy (ART) for ≥30 days were invited to participate.

Laboratory-based performance evaluation of PIMA CD4+ T-lymphocyte count point-of-care by lay-counselors in Kenya.

Background: CD4+ T-lymphocyte count testing at the point-of-care (POC) may improve linkage to care of persons diagnosed with HIV-1 infection, but the accuracy of POC devices when operated by lay-counselors in the era of task-shifting is unknown. We examined the accuracy of Alere's Pima™ POC device on both capillary and venous blood when performed by lay-counselors and laboratory technicians.

Methods: In Phase I, we compared the perfomance of POC against FACSCalibur™ for 280 venous specimens by laboratory technicians.