1. Background: General

There are 38 million people currently living with HIV-1 (PLHIV) worldwide with approximately 1 million deaths each year. According to the 2016 Malawi Population-Based HIV Impact Assessment (MPHIA), 10.6% of adults aged 15 to 64 in Malawi have been infected with HIV, making it one of the countries with the highest prevalence of the disease worldwide. The epidemic is varied; for example, the frequency in the south is significantly higher (16%) than in the north (7.4%). Furthermore, there were 13,000 HIV-related deaths in the country in 2018 and an estimated 1,000,000 people are currently living with HIV (UNAIDS, 2018).

HIV-1 suppression to “undetectable” viral load levels (i.e., below 50 copies/ml in plasma) following initiation of combination antiretroviral therapy (cART) is significantly associated with longevity and improved quality of life. The dissemination and use of low-cost generic first-line cART have made treatment widely available. In East and Southern Africa, approximately 80% of HIV-1 positive people know their status and are on cART but less than 45% have access to a viral-load test. This is driving the emergence of drug resistance isolates. Up to 26% of people who initiate treatment worldwide have first-line drug resistance to HIV-1. Up to 10% of adults starting HIV treatment can have drug resistance to the non-nucleoside reverse transcriptase inhibitors (NNRTI) drug class. Pretreatment NNRTI resistance is up to 3 times more common in people with previous exposure to antiretroviral drugs. The prevalence of drug-resistant HIV is high in children under 18 months of age and newly diagnosed with HIV. Based on surveys conducted in 10 countries in sub-Saharan Africa (2012–2020), nearly half of the infants newly diagnosed with HIV have an NNRTI-resistant virus before initiating treatment. In the worst-affected areas of sub-Saharan Africa however, up to 69% of infants born to HIV-1 positive mothers, carry first-line cART-resistant strains to the only drugs that are cheaply available in these areas. This is a huge public health concern.

Viral load tests cost approximately £50 to £100 each and require a cold chain, specialized equipment, and specially trained staff. Cheaper (~£12 per test), alternative, point-of-care tests such as the GeneXpert® HIV-1 viral load test (Cepheid) have been developed and are being disseminated to secondary and tertiary clinical centers but are limited in the number of samples that can be processed within two hours. Moreover, they still require specialized equipment and a reliable power source. Laboratory-developed assays (LDAs) such as the one developed by Kibirige et al. provide an improved and efficient tool for large-scale patient screening because they can be tailored to the available specimens and run at a lower cost. They provide a more viable treatment monitoring option for resource-constrained settings.

CenRID has been operating in Malawi since 2021. The organization has already conducted a comprehensive readiness assessment in Nkagula Traditional Authority in anticipation of the implementation of Project IRAF (Implementation Research on the Advancement of Family Planning). CenRID currently operates in Zomba District in Southern Malawi.

2. Background: Project & Role Context

To effectively monitor HIV-1 combination anti-retroviral therapy (cART) and support HIV-1 cure studies internationally, there is a need for relatively simple low-cost sensitive assays that can reliably quantify low levels of HIV-1, across different viral subtypes. Kibirige C. et al., developed, patented, and published a sensitive HIV-1 LDA in January 2022. Validation studies following US FDA guidelines demonstrated the assay to have a limit of quantification of 88 copies of HIV-1 RNA per ml or the equivalent of 1 infected cell with 95% efficiency. It is 95.75% accurate, 100% sensitive, and 93.24% specific for HIV-1. It showed a 99.2% detection rate on an accredited panel of 127 diverse global HIV-1 isolates. Dr. Kibirige has further developed the assay into a cost-effective qPCR kit that does not require a cold chain or special equipment. This HIVQuant Project will thus seek to evaluate and compare the implications, performance, validity, and reliability outcomes of the qPCR kit.

The Clinical Research Coordinator will supervise molecular work; extraction, purification, and quantification of total HIV-1 nucleic acid in plasma and PBMC per established SOP, facilitate and coordinate the daily clinical molecular activities that support the comparative performance evaluation of the qPCR kit at the Zomba Central Hospital in Southern Malawi. This position will assist in the implementation of a preliminary needs assessment that includes gender analysis of issues affecting access to routine viral load monitoring, and the creation of a community advisory board (COB) to enhance the study’s outcomes by improving the dissemination of the study’s reports and providing additional protection for ethical conduct. The Clinical Research Coordinator will serve under the supervision of, and report to the Co-Principal Investigator or his/her designee.

3. Duties, Knowledge, & Qualifications

The Clinical Research Coordinator will carry out these duties and must demonstrate the following skills and experience in their application to be considered

i. Coordinate with the Co-Principal Investigator, the COB, the Zomba Central Hospital, and other relevant stakeholders to ensure that the research study and related activities are performed in accordance with national regulations and institutional policies and procedures.

ii. Assist in the preparation of study-related documentation, including activity worksheets, procedural manuals, event reports, institutional review board documents, and progress reports.

iii. Facilitate focus group discussions with study participants, the COB, and other relevant stakeholders during the implementation of the preliminary needs assessment.

iv. Attend investigator and study advisory meetings as requested by the Co-PI.

v. Coach Molecular Technologists on the ethical, scientific, and procedural aspects of the study, including a commitment to gender equality, standards of care, informed consent, etc.

vi. Design promotional strategies and related materials to encourage participation and support for the study, and help increase uptake of the study’s findings.

vii. Knowledge of all laboratory procedures and specimen submission requirements, and solid understanding and utilization of proper safety practices.

viii. Ensure strict compliance with established GCLP and ISO 15189:2021 laboratory guidelines, and other biosecurity policies and procedures.

ix. Perform other duties as assigned.

x. Hold a Bachelor’s degree or equivalent in Life sciences, Biomedical Laboratory Technology, Medical Laboratory Services, Microbiology, or a related field. Master’s Degree preferred.

xi. At least five (5) years of clinical research and molecular diagnostic experience is required.

xii. High level of interpersonal communication skills, including the ability to interact with project stakeholders and district officials.

xiii. Demonstrated ability to work in a fast-paced molecular environment, and able to prioritize and manage workloads effectively.

4. How to Apply

Interested candidates should submit a resume/cv and a cover letter via email at [email protected] by 11 pm on March 20th 2023, Malawi time with “Name_Clinical Research Coordinator” in the subject line.

Only shortlisted applicants will be contacted.