Materials and Links

Putting HIV diagnostic and monitoring technologies into context

Excerpts from the Declaration of Commitment on HIV/AIDS, United Nations General Assembly Special Session on HIV/AIDS, 25-27 June 2001:

(23)Recognizing the effective prevention, care and treatment strategies will require behavioral changes and increase availability of and non-discriminatory access to, inter alia, vaccines, condoms, microbicides, lubricants, sterile injecting equipment, drugs, including anti-retroviral therapy, diagnostics and related technologies, as well as increased research and development;

(24) Recognizing also that the cost, availability and affordability of drugs and related technology are significant factors to be reviewed and addressed in all aspects and that there is a need to reduce the cost of these drugs and technologies in close collaboration with the private sector and pharmaceutical companies;

(55) By 2003, ensure that national strategies, supported by regional and international strategies, are developed...to strengthen health-care systems.....Also, in an urgent manner make every effort to provide progressively and in a sustainable manner the highest attainable standard of treatment for HIV/AIDS, including the prevention and treatment of opportunistic infections, and effective use of quality-controlled anti-retroviral therapy in a careful and monitored manner to improve adherence and effectiveness and reduce the risk of developing resistance;

(56) By 2005, develop and make significant progress in implementing comprehensive care strategies to: strengthen family and community-based care, ... improve the capacity and working conditions of health care personnel, and the effectiveness of supply systems, financing plans and referral mechanisms required to provide access to affordable medicines, including anti-retroviral drugs, diagnostics and related technologies.....

(71) Support and encourage the development of national and international research infrastructures, laboratory capacity, improved surveillance systems, data collection, processing and dissemination, and the training of basic and clinical researchers, social scientists, health-care providers and technicians, with a focus on the countries most affected by HIV/AIDS, particularly developing countries and those countries experiencing or at risk of a rapid expansion of the epidemic;

(72) Develop and evaluate suitable approaches for monitoring treatment efficacy, toxicity, side effects, drug interactions and drug resistance, and develop methodologies to monitor the impact of treatment on HIV transmission and risk behavior.

These excerpts point to the research and implementation activities that need to happen in order to assure the "highest attainable standard of treatment for HIV/AIDS". The urgency of development in this area is also illustrated by the current WHO Treatment Guidelines¹ which point to the need of being able to establish diagnosis of infection in adults, children and infants, assess when to start treatment and monitor the efficacy and safety of treatment. We trust that this open forum for discussion representing a collaboration between the Forum for Collaborative HIV Research, the CDC, NIH and WHO will result in a few steps of progress towards this goal.

The process of the transfer and implementation of suitable laboratory technologies has many steps. We have chosen to start by focusing on three specific models (two CD4 and one viral load assays) to illustrate how collaborations and networking between the public and private sectors can be encouraged and nurtured to facilitate a more rapid, focused, non-duplicative approach to "getting there". This applies not only to the two sectors, but also to collaboration within each of these, as illustrated by inter- and intra-agency networking, between agencies, organization and research networks and also amongst the various pharmaceutical and diagnostic commercial endeavors. It was our idea that once the "process" is mapped out, other new methodologies will have an easier time to follow the path.

The Forum for Collaborative HIV Research will stay committed to further work in this area. We plan to continue working with the collaborating agencies, networks and industries to initiate discussions on laboratory monitoring of drug toxicities as well as the facilitation of quality assurance issues.

We hope that the readers will find this report stimulating and useful. If this report has aided readers in specific ways, we would appreciate hearing about it. Please send your comments to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

The work proposed in Phase II of the Forum's project Transfer of laboratory diagnostic and monitoring technology to resource poor settings is a continuation of the first phase of this project, (see past projects). In the first phase, specific follow-up activities involving working groups and future workshops were proposed. The Forum has made a strong commitment to continuing work in this area.

Objectives for Phase II:

• To continue facilitating the process of clinical validation and transfer of the technologies into resource poor setting
• To facilitate progress for the two working groups (alternative technologies for CD4 cell counting and viral load)
• To convene a small workshop on QA/QC issues
• To continue working with individuals and/or groups developing alternative technologies that are not as far along the pathway to clinical validation and implementation

Current status:

A workshop on QA/QC issues was held on October 30th, 2003, in Warsaw, Poland (right after the European AIDS Clinical Society Meeting).

Ongoing telephone conferences with members of the virology and CD4 working groups.

Project Manager:
Ben Cheng

Project Specific Sponsoring:
CDC-GAP, Doris Duke Charitable Foundation, Bill & Melinda Gates Foundation