HIV Drug Resistance Training Welcome and Introductions Note: Prior to training, post sheets of paper in various areas spread around the room. On each sheet, write one of the words/phrases below. If you have a small training group, you should eliminate some of the sheets, since you want to have a number that will get people together in groups of four or more. Quality control Networking with other labs Deciding if genotyping is right for us Lab set up Interpreting and analyzing test data Stocking and supplying the lab Developing procedures Choosing a testing methodology Welcome participants to the training. Introduce yourself and describe your background/expertise.

Magnet Words Look at the words and phrases on the wall. Go stand by one sign. With others at the same sign, introduce yourselves and discuss: Why did you choose this sign? What do you hope to get from this training, related to the words on the sign? Refer participants to the “signs” on the wall (see note on slide 1). Introduce the ice breaker activity: You probably feel attracted to some of these words and phrases because they interest you. Those signs are like magnets. In one moment, I’d like you to choose one of these signs and go stand by it. You will find yourself in a group of people who are also interested in this topic. Once you are all together, discuss the questions on the slide. Ready, set, go! Facilitate movement toward the signs. (If there is a sign with just one person, encourage that person to choose another sign that attracts him/her.) After participants have had a few minutes to talk, ask them to return to their seats. Transition: Now, you have met some of your fellow participants and had a chance to talk a bit about your expectations. Let’s continue with formal introductions.

Introductions “I am (name), and I am a (role/job) from (where). I am here because (reason for being here/what you hope to learn).” Facilitate participant introductions: Ask each person to introduce themselves, providing the information on the slide. Model this by re-introducing yourself. Model brevity. Go around the room and ask each person to complete the sentence on the slide. As participants provide the information, record their expectations on a flipchart. Go over the expectations and explain which ones you expect to meet in this training.

Purpose of Training Identify ways to measure HIV drug resistance Use HIV DR Assays effectively and efficiently Promote “best practices” in national and regional labs Present background information: WHO has developed a comprehensive strategy for minimizing the emergence and transmission of HIV drug resistance (HIVDR) at the population level. The purpose of the strategy is to prolong and maximize the quality of life of people living with HIV by supporting optimal antiretroviral therapy programme functioning, maintaining the effectiveness of standard first- and second-line antiretroviral regimens used in low- and middle-income countries and potentially reducing HIV transmission. The WHO Global HIV Drug Resistance Laboratory Network was formed to provide quality-assured laboratory results for HIV drug resistance surveillance and monitoring. The WHO HIVDR Lab Network Advisory Group, which includes a limited selection of laboratories throughout the world including CDC/Atlanta, is assisting WHO in the development of guidelines and standards. In an effort to standardize genotyping testing and laboratory procedures in resource-limited countries, WHO and CDC have developed a DR training curriculum. Present information on the purpose of the training (points on slide).

Who the Training is For National Genotyping Lab Directors Policy and Advocacy Lab infrastructure Develop and manage DR testing programme Senior Lab Technicians Technical skills Responsible for entire testing process Present: We have invited two participants from each selected laboratory—the director and a senior lab technician. We expect the directors to set an overall direction and put in place the infrastructure and policies needed to develop the DR testing programme. We expect the senior lab techs to oversee the entire process within the labs. This workshop is dry training (no lab work involved) and will focus on getting countries and labs ready for DR testing. Additional training is needed for hands-on training in testing procedures. 

Training Outcomes: National Reference Lab Directors Set up a DR lab following quality and biosafety standards (both physical infrastructure and the workflow) Manage the lab and DR testing program to achieve quality testing/reporting and to support ARV program expansion Establish QA/QC program for DR testing, including reporting Select qualified personnel to perform DR testing Present the training outcomes for the directors. As appropriate, relate these outcomes to participants’ expectations from the introductions.

Training Outcomes: Senior Lab Technicians Identify gaps in your own lab and work with the lab directors to achieve standards for DR testing Perform and understand the DR test procedures Monitor the quality of DR testing on a daily basis Manage the entire specimen handling process Ensure timely reporting of test results Manage recordkeeping Manage contamination in PCR and sequencing – how to prevent, diagnose, and resolve Take measures to protect safety of self and others Present the training outcomes for the technicians. As appropriate, relate these outcomes to participants’ expectations from the introductions.

Modules and Agenda Overview 1: Introduction to HIV Drug Resistance 2: The WHO Laboratory Network 3: Principles of PCR and HIVDR Sequencing 4: Molecular Lab Set Up and Work Flow 5: Sequencing Procedures 6: Sequencing Interpretation and Analysis 7: Criteria for In-house Assay Validation 8: Dried Blood Spots for HIVDR Genotyping Present the agenda. Note: Adapt this slide and the following one to present your customized agenda information. You may want to put this on a handout as well. The information in the Facilitator’s Overview will help you plan the agenda.

Modules and Agenda 9: A Systems Approach To Laboratory Quality 10: Standard Operating Procedures 11: Quality Control And Quality Assurance 12: Data Management 13: Equipment and Supplies 14: Stock Management 15: Specimen Management 16: Biosafety and Waste Management 17: Laboratory Staffing and Training See previous slide.

Housekeeping Restrooms Breaks Meals Provide any needed housekeeping details. Note: Revise this slide as needed, for example, if you need to include details for parking, overnight arrangements, etc. Transition to the next module.