1. Unit 4: Specimen and Data Collection #3-4-1

2. Warm Up Questions: Instructions  Take five minutes now to try the Unit 4 warm up questions in your manual.  Please do not compare answers with other participants.  Your answers will not be collected or graded.  We will review your answers at the end of the unit. #3-4-2

3. What You Will Learn  By the end of this unit you should be able to: © understand the rationale for conducting unlinked anonymous testing for HIV sentinel surveillance © explain methods for keeping samples anonymous and unlinked #3-4-3

4. What You Will Learn, Cont.  By the end of this unit you should be able to: © explain the importance of standardised forms for data collection © describe the protocols for data collection © identify the necessary demographic information to be collected for analysis #3-4-4

5. Objectives of HIV Testing  counselling persons on their infection  referring them to care  reducing the risk of transmitting or acquiring HIV  ensuring the safety of the blood supply  scientific research  determining eligibility for certain types of employment or health insurance #3-4-5

6. Participation Bias in HIV Testing  To use HIV testing data for surveillance, you must ensure that your data represent the whole target population.  Persons offered testing may have reasons to accept or decline the test.  The HIV testing approach you choose will affect participation bias #3-4-6

7. Considerations in Selecting a Testing Approach  There are 5 considerations that should guide the selection of a testing approach: © Participation bias © Informed consent © Confidentiality © Linking © Result disclosure #3-4-7

8. Approaches to HIV Testing  There are 6 main approaches for HIV testing for surveillance purposes: © Unlinked anonymous testing without informed consent © Unlinked anonymous testing with informed consent © Linked confidential testing with informed consent © Linked anonymous testing with informed consent © Mandatory testing © Compulsory testing #3-4-8

9. Recommended Approach for Sentinel Surveillance  Unlinked anonymous testing (UAT) without informed consent is the recommended testing approach for sentinel surveillance.  UAT is done only in clinic settings where blood is collected regularly for other purposes.  The major disadvantage of UAT is that persons do not get their test results. #3-4-9

10. Recommended Approach for Sentinel Surveillance, Cont.  Linked testing (confidential or anonymous) with informed consent is the preferred approach when the specimens are collected explicitly for the purpose of HIV testing.  An example of when this would happen is HIV surveillance through community-based sero- surveys. #3-4-10

11. Unlinked Anonymous Testing Without Informed Consent  HIV testing is done on specimens of blood collected for other purposes  Individuals do not need to give consent to have HIV testing performed on their blood.  Personal identifying information is permanently stripped from specimen tubes prior to testing for HIV. #3-4-11

12. Unlinked Anonymous Testing Without Informed Consent, Cont.  Data are recorded using codes that do not identify individuals.  Persons do not choose to participate or not participate.  Persons do not get their HIV test results. #3-4-12

13. Determining Eligibility – UAT  The first step in UAT is to identify persons who are eligible for the sample.  This is preferably done at the time of the visit by clinic personnel  Another less desirable way to decide is to review information from the clinic records after the visit. #3-4-13

14. Obtaining Information – UAT  Types of information to be collected include: © basic demographic information age sex geographic area of residence © additional helpful information that can confirm eligibility, such as: date of visit reasons for the current visit date of last visit (if available) in order to verify eligibility #3-4-14

15. Obtaining Information – UAT, Cont.  Other possible data to be collected include: © Additional demographic data socio-economic or educational level occupation marital status © Additional behavioural data number of sexual partners condom use © Additional clinical data signs and symptoms of HIV signs and symptoms of other STIs #3-4-15

16. Step-By-Step Procedure for UAT 1.Clinic staff member #1 collects specimen from patient, and labels it with a code. 2.Clinic staff member #1 labels a clinic form with the same code, and collects demographic and routine clinical information from patient. #3-4-16

17. Step-By-Step Procedure for UAT, Cont. 3.Clinic staff member #1 removes an aliquot of blood sample and places it in a second tube. 4.The second tube with the aliquot of blood is labelled with a new code not linked to personally identifying information. #3-4-17

18. Step-By-Step Procedure for UAT, Cont. 5.The first tube is sent for routine clinical testing (for example: anaemia, syphilis). 6.Staff member #1 records new code on a surveillance form and transfers demographic information (not linked to personal identifying information) from the clinic form to the surveillance form. #3-4-18

19. Step-By-Step Procedure for UAT, Cont. 7.Clinic staff member #2 performs HIV test on blood sample labelled with new code. 8.HIV test results are recorded in a laboratory log-book with the new code and the HIV test result. 9.Demographic information from surveillance forms is matched with HIV test results using the new codes, and then analysed. #3-4-19

20. Labeling Specimens and Logging Test Results  Clear, consistent, and durable labeling of specimens is very important in UAT  Test results should be logged in a book with only the specimen code and the HIV test result  In labeling specimens and logging results, great care must be taken to protect confidentiality #3-4-20

21. Flow of Data Collection Forms #3-5-46 #3-4-21

22. Warm Up Review  Take a few minutes now to look back at your answers to the warm up questions at the beginning of the unit.  Make any changes you want to.  We will discuss the questions and answers in a few minutes. #3-4-22

23. Answers to Warm Up Questions 1.True or false? In unlinked anonymous testing, it is okay to maintain information about the identity of the patient, in order to inform them about their treatment options if they test positive. False #3-4-23

24. Answers to Warm Up Questions, Cont. 2.Place the following events in the correct order, corresponding to the proper procedure for unlinked anonymous testing. a.blood is collected and labelled with a code b.specimen is tested for HIV c.personal identifying information is removed from specimen d.aliquot is removed into new tube for HIV testing a, d, c, b #3-4-24

25. Answers to Warm Up Questions, Cont. 3.True or false? Unlinked anonymous testing without informed consent can sharply reduce participation bias. True #3-4-25

26. Answers to Warm Up Questions, Cont. 4.Place the following events in the correct order, corresponding to the preferred data collection method for unlinked anonymous testing: a. send form to laboratory b. add HIV test result to form c. add demographic data to form d. remove demographic section of form and send to data manager c, d, a, b #3-4-26

27. Answers to Warm Up Questions, Cont. 5.Which of the following is not a reason for the use of standardised data collection forms? a. to ensure that the necessary information is obtained b. to ensure that data from different sites can be easily compared c. to ensure that a patient’s personal information can be matched with their test result d. none of the above Standardised data collection forms allow for greater ease in data collection. Matching a patient’s information to their test result is irrelevant, and sometimes is even undesired. #3-4-27

28. Answers to Warm Up Questions, Cont. 6.True or false? For linked confidential surveys, a separate laboratory form for serologic results should be used so that laboratory personnel do not have access to the patient’s personal identifying information. True. Since testing is confidential, laboratory personnel should not be able to identify the patient with his or her test result. #3-4-28

29. Answers to Warm Up Questions, Cont. 7.For unlinked anonymous testing, as it is used in sentinel surveillance, which of the following variables would be inappropriate to collect: a.patients age b.patients marital status c.Patients number of children d.None of the above Knowing the patient’s number of children is not necessary. #3-4-29

30. Small Group Discussion: Instructions  Get into small groups to discuss these questions.  Choose a speaker for your group who will report back to the class.  Take 15 minutes for this exercise. #3-4-30

31. Small Group Reports  Select one member from your group to present your answers.  Discuss with the rest of the class. #3-4-31

32. Case Study: Instructions  Try this case study individually.  We’ll discuss the answers in class. #3-4-32

33. Case Study Review  Follow along as we go over the case study in class.  Discuss your answers with the rest of the class. #3-4-33

34. Questions, Process Check  Do you have any questions on the information we just covered?  Are you happy with how we worked on Unit 4?  Do you want to try something different that will help the group? #3-4-34

35. CDC Global AIDS Program Annex 4.2: Unlinked Anonymous Testing (UAT) for HIV Sentinel Surveillance #3-4-35

36. Purpose of Unlinked Anonymous HIV Testing (UAT)  To monitor trends  To develop estimates and projections  To assist with program planning  To target interventions more accurately #3-4-36

37. UAT without Informed Consent  1. UAT without informed consent must only use left-over blood/fluids from routinely-collected specimens.  2. Data resulting from surveillance using UAT methods must be irreversibly unlinked and rendered anonymous prior to HIV testing.  3. Rapid HIV testing for UAT surveillance should not be conducted at the point and time of service provision. #3-4-37

38. UAT without Informed Consent, Cont.  4. Data collection for UAT surveillance should be limited to that which is routinely collected as part of clinical services.  5. Voluntary counseling and testing (VCT) should be available and accessible to patients from sites where UAT surveillance is being conducted.  6. Data generated through UAT-based HIV sentinel surveillance should be used for program planning and evaluation, and for advocacy purposes. #3-4-38

39. UAT with Informed Consent  The procedures for conducting UAT with informed consent are the same as those for UAT without informed consent, except: © Blood/fluids collected for non-routine purposes may be used © Data collected do not need to be limited to that which is routinely collected as part of clinical services #3-4-39

40. UAT with Informed Consent, Cont.  The consent must explain the purpose of the survey and that HIV test results will not be returned.  The anonymising procedure methods must be irreversibly unlinked and rendered anonymous prior to HIV testing, with additional provisions to assure anonymity, despite face-to-face contact between the client and the surveillance staff. #3-4-40

41. Recommendations  The CDC Global AIDS Program encourages all countries and programs that are supporting UAT surveillance in antenatal clinics to do the following: © Collect information on the availability and uptake of PMTCT services that are located in UAT ANC sites © Examine the possibility of using PMTCT data for surveillance #3-4-41