ICRHK, in collaboration with the PASER networks, PharmAccess Foundation, the Department of Global Health at the Academic Medical Centre of the University of Amsterdam, and the Amsterdam Institute for Global Health and Development, implements the PASER-M study with funding from the Ministry of Foreign Affairs of the Netherlands.

The study monitors HIV drug resistance (HIVDR) in patients on Highly Active Antiretroviral Therapy (HAART) to strengthen treatment outcomes and inform global HIV care strategies. HIVDR is recognized as one of the most critical determinants of long-term treatment success. By monitoring its emergence over time in prospective cohorts on HAART, the study identifies programmatic and patient factors affecting treatment durability and supports policymakers in optimizing ART programs.

Geographic Scope
The study spans multiple countries and sites in sub-Saharan Africa:

• Ethiopia:MBL
• Uganda:JCRC TREAT sites (3)
• Kenya:ICRHK, Coast Provincial General Hospital (CPGH), Mater Hospital
• Rwanda:TRAC+
• Zambia:Lusaka Trust Hospital, KARA Clinic, Coptic Hospital
• Zimbabwe:Connaught Clinic (SACI)
• South Africa:MuelMed Hospital, Themba Lethu Clinic, Acts Clinic (RTC)

Reference Laboratories:

• Uganda: Joint Clinical Research Center
• South Africa: NHLS, University of the Witwatersrand

Study Objectives

• Measure the emergence of HIVDR over time.
• Detect specific HIVDR mutations and mutational patterns.
• Evaluate the success of ART programs in minimizing HIVDR.
• Assess associated patient factors, including adherence.
• Disseminate results to policymakers to strengthen ART program practices.

Methodology
Each clinical site consecutively enrolls up to 240 HIV-infected adults initiating first-line HAART or switching to second-line regimens. In addition to routine HIV care, participants undergo viral load testing and genotypic HIVDR analysis at baseline, 12 and 24 months, at the point of regimen switch due to treatment failure, and at study conclusion. Patient follow-up ranges from 24 to 48 months.

Impact

• Enrolled and followed large multicountry cohorts of HIV-infected adults, generating comprehensive data on HIVDR in sub-Saharan Africa.
• Detected early patterns of HIV drug resistance mutations, informing ART program design and treatment protocols.
• Strengthened national and regional ART monitoring systems by integrating viral load and genotypic testing approaches.
• Disseminated results to policymakers, supporting improved ART program practices.
• Produced high-quality scientific outputs, including the multicenter observational study“HIV-1 drug resistance in antiretroviral-naïve individuals in sub-Saharan Africa after rollout of antiretroviral therapy.”