the unitaid-funded msf diagnostics project: plans to incorporate the new who recommendations and how...
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The UNITAID-funded MSF diagnostics project:
Plans to incorporate the new WHO recommendations and how best practices will be
shared with, and disseminated by, WHO
Teri Roberts
Diagnostics Advisor
Medecins Sans Frontieres, Access Campaign
7th International AIDS Conference
2 July 2013
Viremic patients can re-suppress following an adherence intervention
Bonner K et al. J Acquir Immune Defic Syndr. 2013 Jun 14
The importance of preserving first line, affordable, robust, one-pill-a-day regimens
Ref: Untangling the Web of ARV Price Reductions 16th Edition, July 2013
Implementation is done in support of, and in collaboration with, the Ministries of Health and reference laboratories
The UNITAID-funded MSF diagnostics project
• Goal: Improved clinical outcomes for PLWHA in resource-constrained settings through models of care for optimal use of PoC CD4, laboratory-based and PoC viral load and EID testing
• 3 year project – $28.7 million• Eight sites in seven countries – Lesotho, Malawi (2), Mozambique, South Africa,
Swaziland, Uganda and Zimbabwe.• MSF field missions will compare the feasibility, outcomes and cost-effectiveness
of point-of-care testing versus district- or regional-level laboratory-based testing for CD4 and viral load & EID through comparative operational research
• MSF Access Campaign will perform market intelligence work and ensure price transparency along the value chain
• Evidence-based findings will be disseminated and used to influence policy• Expected results on market: helping the market launch of products, increasing
competition, decreasing pricing, breaking monopolies
Operational Research Framework
1. Policy and research landscape review
2. Descriptive cohort and cross-sectional studies• Cohort/cascade outcomes,• Prevalence of failure and 2nd line• Prevalence of VL ranges in treated patients, including thresholds• Prevalence of genotypic resistance
3. Impact and costs of VL vs CD4 monitoring strategies
4. Validation and costing of tools and approaches• Improved lab-based options• PoC tools• M-health tools• Adherence support
5. Comparison of different algorithms using validated tools
6. M&E
Plans to incorporate the new WHO recommendations
MSF is pleased with, and intends to provide support to implement, the new WHO guidelines by:
1. Demonstrating HOW to implement the guidelines
2. Demonstrating the ADDED VALUE of the new guidelines
3. Supporting QUALITY (scale-up without mess-up)
4. Working with partners to SUPPORT implementation (e.g. so that Ministries of Health can make informed decisions) and with WHO wherever possible
How best practices will be shared with, and disseminated by, WHO
Evidence-based results provided to the WHO wrt POC CD4 testing will include:1. Use of point-of-care CD4 to plug the leaky cascade between test and treat
Evidence-based results provided to the WHO wrt routine viral load monitoring will include:
2. Feasibility of real-world implementation of tools and best tools for RLS (including the use of dried blood spots and m-health)
3. Possibilities for decentralisation and task shifting
4. Benefits of routine VL testing plus adherence support vs targeted VL testing and clinico-immunological testing
5. Dropping CD4 monitoring of treated patients who are virologically suppressed
6. In what situations or contexts point-of-care testing makes sense
7. Best algorithm and threshold for diagnosing treatment failure
8. Modelling data that is built on credible, real-world data (so that long-term outcomes can be modelled)
9. Psychological benefits to patients (e.g. motivation, empowerment)
10. Costing: cost-effectiveness of different strategies as well as cost-saving methods e.g. sample pooling
11. Transparent and comprehensive in-country pricing and market intelligence data