1. ANE, E&E and GH Training Course “On the Road to Excellence” Commodity Management for Voluntary Counseling and Testing

2. Outline of the Presentation Selecting HIV test kits to procure Quantification of needs Procurement of HIV test kits using USAID funding Partnership and collaboration to strengthen VCT commodity management Potential roles for donor support for VCT commodity management

3. Selecting HIV test kits to procure Regulatory and policy considerations  Does the cooperating country have HIV testing algorithm or guidelines? If yes, is the HIV test kit to be procured included in the algorithm/guidelines?  Is the HIV test kit licensed for use in the cooperating country?  Does the cooperating country provide laboratory testing of the HIV test kit (quality assurance) that confirms that it meets selected reference standards?  Will procurement of the HIV test kit harmonize with other donations?

4. Selecting HIV test kits to procure Expert opinion on the product If country HIV testing algorithm/guidelines do not exist  Has the performance of the HIV test kit been evaluated? If yes, by whom?  Has the HIV testing strategy and the algorithm/ guidelines been evaluated and approved in the cooperating country? If yes, by whom?  Does the country have any prior history or experience of using this HIV test kit? If yes, have any problems with safety, efficacy and quality been experienced?

5. Selecting HIV test kits to procure Local capacity/context considerations  Is the language of the instructions appropriate?  Is technical expertise available to use the product correctly?  Are the technical staff trained or experienced in using the product?  Is additional equipment available that is essential to use the test kit correctly?  Does the kit require refrigeration? Is adequate refrigeration and a regular power supply available?  Pack size for low volume sites/ normal shelf life on delivery/ regular availability from supplier/ cost considerations.

6. Quantification of HIV test kits Complexities of estimating how much to buy  New programs – no consumption data available  New programs – initial peak of HIV positive results increasing quantities of second line and tie breaker tests  Scaling up - accounting for speed and scale up of planned expansion  Anticipating changes in the needs of population being served  Estimating needs for QA testing/training/wastage  Serial versus parallel testing  Short expiry dates of HIV test kits

7. Quantification of HIV test kits Methodology – consumption/HIV seroprevalence/adjusted consumption methods Use at least 2 methods Serial versus parallel testing – quantification implications New programs – “filling the pipeline” Lead time and buffer/safety stocks Adjustments for QA/training/inexperience of laboratory staff/short expiry dates

8. Procurement of HIV test kits using USAID funding ADS/CFR regulations and polices for “pharmaceutical products” include HIV test kits Safety, efficacy and quality – FDA approved or “information must be available to attest to safety, efficacy and quality of the pharmaceutical product “Buy America” – U.S. source and origin Protection of U.S. patents

9. Procurement of HIV test kits using USAID funding Source/origin waiver for HIV test kits  USAID Action Memorandum January 11, 2001 effective until 2007  Geographic code 935 is an authorized source/origin for selected HIV test kits listed in Tab 1 of source/origin waiver  Kits in Tab 1 have been reviewed and approved by CDC for safety and efficacy  List in Tab 1 is to be updated as new or improved kits become available

10. HIV test kits listed in Tab 1 BionorCapillus DetermineDoubleCheck Genie IIHema-Strip HIV SpotHIVSav MultispotSeroCard Sero-Strip

11. Procurement of HIV test kits using USAID funding Source/origin waiver for kits not listed on Tab 1 Criteria to be fulfilled:  Product is essential to the activity  Product is not available from US or delivered price from US is 50% or more  Product is FDA-approved or information is available to attest to safety, efficacy and quality of the test kit

12. More information Requesting USAID Approval to Procure HIV Test Kits and Other HIV/AIDS-Related Pharmaceutical Products: Guidance and Sources of information HIV Test Kits Listed in the USAID Source and Origin Waiver – Procurement Information Document

13. Partnership and collaboration to strengthen VCT commodity management Establishing an inclusive process to facilitate coordination, communication and collaboration between stakeholders has been shown to be effective in strengthening VCT services Must include all stakeholders: national government, NGOs, CBOs, private sector, UN agencies and international donor agencies

14. Establishing a process for partnership and collaboration can help to: Identify key stakeholders and map roles in providing or supporting VCT Identify gaps and duplication Allow stakeholders to build on relative strengths Identify success to build on Identify opportunities for harmonizing and streamlining roles and approaches Enable stakeholders to plan for collaborative action

15. Potential roles for donor support for VCT commodity management Helping countries to develop a national long-term strategic plan for scaling up VCT services – include a commodity financing plan Fund and facilitate appropriate technical support to strengthen VCT commodity management Support the development/update of national HIV testing algorithms/guidelines Help countries establish an inclusive process to facilitate coordination, communication and collaboration between key stakeholders and players

16. Considerations for donor support for VCT commodity management Ensure donor-funded technical support conforms and harmonizes with established in-country policies and procedures Ensure donor-financed procurement of HIV test kits and other commodities harmonizes with national HIV testing guidelines Use existing supply and distribution channels where available. If a vertical supply system is established as a short term fix, develop a strategy for integration in the long term