AMPHEUS

AMPHEUS: Scalable technological infrastructure to support genomics-based HIV intervention strategies in Africa

Introduction
Zambia continues to make remarkable progress toward the attainment of HIV epidemic control, with the national incidence of HIV decreasing from 0.61% in 2016 to 0.31% in 2021. However, the country has also seen an increase in viral load suppression among people living with HIV aged 15 and above, regardless of their knowledge of HIV status or use of Antiretroviral Treatment (ART). Despite national progress, some sub-groups and regions still have gaps and unmet needs, such as the prevalence of viral load suppression among men and women. Rural areas face challenges in routine viral load monitoring, with only 36% of HIV positive individuals receiving results from their last test, according to the ZAMPHIA 2021 survey.

The increasing rates of HIV drug resistance (HIVDR) threaten to ruin progress towards HIV epidemic control. Factors contributing to this include increased usage of antiretrovirals, poor adherence, limited access to viral load monitoring and drug resistance testing, use of less potent ART regimens, and transmission of drug-resistant HIV. To sustain gains and reach HIV epidemic control, timely diagnosis of virological failure and HIV drug resistance is crucial. HIVDR is a significant threat to HIV epidemic control in lower- and middle-income countries. The 2022 Zambian Consolidated Guidelines recommend HIV resistance testing for patients failing Dolutegravir- and Protease Inhibitor-based regimens with a repeat viral load above 1,000 copies/mL. Long turnaround times for routine viral load and drug resistance results may cause patients to continue on ineffective ART regimens, potentially leading to poor clinical outcomes. Early diagnosis of drug resistance is crucial for optimizing antiretroviral therapy (ART), viral load control, and clinical outcomes. High-throughput sequencing of HIV genomes faces technical challenges such as cost, complexity, sensitivity, and accuracy.

The AMPHEUS Project, funded by the Gates Foundation, aims to deliver a single platform for clinical microbiology, real-time epidemiology, and intervention research in low-income settings. This study evaluates AMPHEUS’s role in HIV/AIDS and ART clinical decision-making in Zambia.

Aim
This study’s aim is to test and evaluate the role of a novel rapid HIV viral load testing and whole genome sequencing platform (AMPHEUS) on clinical decision-making at health facility level in a high HIV prevalence and resource-limited setting.

The objectives are;
• To evaluate the feasibility and costs of HIV viral load and drug resistance testing using the AMPHEUS platform on routinely collected blood samples at health facilities in Zambia.
• To assess if the use of AMPHEUS could potentially lead to changes in clinical management and improvement of patient outcomes in PLHIV attending health facilities in Zambia.
• To study the burden and epidemiology of HIV drug resistance mutations (major and minor variants) in PLHIV initiating ART and assess impact on consequent viral suppression in PLHIV attending health facilities in Zambia.
• To evaluate the acceptability of HIV drug resistance testing using AMPHEUS among ART providers and PLHIV in Zambia.
• To build capacity among ART providers in Zambia on the understanding and management of HIV drug resistances.

Timeline
This study will be conducted from January 2020 to December 2025

Funded by BMGF