TERMS OF REFERENCE
Purpose of the Consultancy
The Common Management Units for HIV, TB and Malaria, under the Ministry of National Health Services, Regulations and Coordination, has approached WHO for optimization of existing National HIV testing Algorithm, to identify best combination of rapid diagnostic tests (RDTs) through a HIV algorithm verification study using WHO recommended protocol. The objective of this validation study is to provide the necessary evidence to identify accurate and affordable combinations of quality-assured RDTs, including dual HIV/syphilis RDTs.
The purpose of this consultancy is to provide support for the implementation of National HIV testing algorithm verification study and transition process as per WHO protocols.
Background
Providing accurate, timely, and affordable HIV diagnosis at the point of care (POC) is a critical first step towards delivering HIV treatment and prevention services. To establish HIV diagnosis, the World Health Organization (WHO) recommends HIV testing strategies using a combination of three HIV serology assays including rapid diagnostic tests (RDT) and enzyme-immunoassays (EIA).
Each assay should have sensitivity 99% (the assay is reactive for at least 99 out of 100 truly HIV-positive specimens) and specificity 98% (the assay is non-reactive for at least 98 out of 100 truly HIV-negative specimens); these are the minimum thresholds for approval through the WHO prequalification procedure. The algorithm should be designed to achieve at least 99% positive predictive value.
A standardized testing strategy and quality-assured products are critical for accurate diagnosis, while poorly chosen testing algorithms can lead to misdiagnosis. Verification of testing algorithms provides objective evidence, before widespread implementation, that a specific combination of products will accurately diagnose HIV infection. To do this, verification assures that the products selected do not have the same false-reactive results, which would lead to misdiagnosis. When products are less than 100% specific, false HIV-reactive results are expected, but when two or more products are false-reactive on the same individual (shared common false reactivity), then misdiagnosis or delayed diagnosis can occur.
This verification study will facilitate updating and alignment of current HIV testing algorithms with the latest WHO recommendations, ensuring that testing algorithms that minimize the risk of misdiagnosis are selected prior to wider use. Furthermore, this study supports the selection of specific products that suit the operational needs of the country. Also, due to existing HIV testing algorithm, due to single recommended RDT at the level of T1, T2 & T3, there are issues reported with procurement, consequently stock-outs and non-compliance of recommended HIV testing algorithm.
Planned timelines: 06 months, to start tentatively from 20 April 2026
Work to be performed
The selected consultant will be responsible for coordination and implementation of WHO HIV algorithm verification study protocol.
The consultant will work under supervision of National Professional Officer for HIV and Viral Hepatitis and is expected to provide support to conduct the following activities:
Output 1: National Technical Working Group (TWG) is established and operationalized to guide the algorithm transition process
Deliverable 1.1: Support the setting up of national technical team/working group (TWG) to guide the algorithm transition process (Concept paper, TOR, notification);
Deliverable 1.2: Support regular meetings of TWG and consultations with key stakeholders (agenda, minute, slide deck etc.)
Output 2: Provide technical support for conducting algorithm transition process
Deliverable 2.1: In consultation with the TWG, adapt WHO HIV algorithm verification study protocols
Deliverable 2.2: Facilitate submission of endorsed protocols to national ethical review board
Deliverable 2.3: Support the product selection for verification study and procurement procedure of the material and reagent needed for the study
Deliverable 2.4: Develop country adapted verification study supportive tools: training materials, questionnaires, forms, SOPs, job aids and reporting tools
Deliverable 2.5: Support identification/Recruitment study personnel: sample collection, laboratory testing, data collection, supervisor(s)
Deliverable 2.6: Support preparation of selected sample collection and study sites
Deliverable 2.7: Central and site training of recruited personnel involved in the verification study
Output 3: Algorithm transition process, is conducted
Deliverable 3.1: Ensure logistics for sample collection and transport to the designed verification study laboratory are in place
Deliverable 3.2: Support /supervise the Laboratory testing and data/result collection process
Deliverable 3.3: Support data collection quality check
Output 4: Data analysis, reporting and dissemination, for Algorithm transition, is conducted
Deliverable 4.1: Support analyses and interpretation of study results and proposed potential algorithms
Deliverable 4.2: Draft study result report and develop dissemination material (slide deck, manuscript) in collaboration with the country technical working group
Deliverable 4.3: Support study results validation workshop organisation
Deliverable 4.4: Finalise study report including validated new national algorithms
Deliverable 4.5: Draft national scale up plan of newly validated algorithms
Technical Supervision
The selected Consultant will work on the supervision of:
Responsible Officer: Dr Safdar Kamal Pasha
Manager: Dr Narantuya Jadamba
Specific requirements
Qualifications required: University degree in medicine, public health, epidemiology, biomedical sciences, or related field.
Experience required: At least 7 years of experience in public health / laboratory / referral laboratory preferably dealing with communicable diseases;
Skills / Technical skills and knowledge:
- Laboratory experience in an HIV diagnostic laboratory performing HIV testing using rapid tests, ELISA, PCR, viral load, and CD4 assays.
- Proven experience in laboratory assessments, SOP development, and staff training is required. Knowledge of WHO and national HIV testing guidelines, biosafety standards, and data reporting systems is essential.
- Advanced data analysis and statistical interpretation, technical, algorithm evaluation and documentation, data visualization and presentation, stakeholder workshop facilitation, and national scale-up planning.
- Ability to write analytical technical reports.
Language requirements:
Excellent command of English and local language.
Place of assignment
Islamabad
Medical clearance
The selected Consultant will be expected to provide a medical certificate of fitness for work.
Travel
The Consultant is expected to travel within Pakistan (Karachi and Lahore) depending on need. Travel requests will be raised in due course in coordination with NPO – HIV/Hepatitis in WHO Pakistan
All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.
Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.