RDS DATA COLLECTION System Manual

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Information about RDS DATA COLLECTION System Manual

Published on December 10, 2016

Author: BryantAdmin

Source: slideshare.net

1. Created by © BRYANT Research Systems 2012 0 BRYANT RESEARCH SYSTEM BROCHURE & OPERATIONAL MANUAL

2. Created by © BRYANT Research Systems 2012 1 SECTION INDEX PAGE I SITE FLOW AND SCHEMATIC 2 II ELIGIBILITY SCREENING 3 III FINGERPRINT SCANNING AND VERIFICATION 12 IV SCREENING ELIGIBILITY WITH THE ELIGIBILITY QUESTIONNAIRE 22 V INTERVIEWER 28 VI HCT COUNSELOR 42 VII ADMINISTERING PARTICIPANTS IN RESEARCH SITE 43 VIII PEER RECRUITMENT INSTRUCTIONS (Q & A) 49 IX SECONDARY INCENTIVE PAYMENT INSTRUCTIONS 55 X RETURN VISIT 65 Appendix A

3. Created by © BRYANT Research Systems 2012 2 BRYANT Research System I. SITE FLOW AND SCHEMATIC (Note: this needs to be determined based on available staff and scheduling – the below is a rough estimate based on hours per day, length of visits and number of staff) 1st Visit: We have had 46 participants screened per day. This requires six AWEBSI stations to capture the participant questionnaire. RECEPTION SCREENER CONSENT Eligibility Questionnaire INTERVIEWER Consent CHECKED AWEBSI Questionnaire COUNSELLORConsent CHECKED DBS STI Tests Pre Test Counsel Hiv Test Result Post Test Counsel COUPON MANAGER 1st Visit Checklist CONTACT DETAILS INVALID DECLINEDCONSENT RETURN for HTC RETURNVISIT Incentive Paid Verify COUPON INVALIDFP INVALID COUPON DECLINEDCONSENTINELIGIBLE SCAN Fingerprint Verify Fingerprint DECLINED CONSENT for DBS RETURN FOR HTC VALID FINGERPRINT Issue Recruitment Coupons Ineligible Ineligible Participant Verify Fingerprint Validate Coupon DECLINED CONSENT INVALID FINGERPRINT

4. Created by © BRYANT Research Systems 2012 3 II. ELIGIBILITY SCREENING Main events at the screening stage Verification of coupon - Each recruit must come with their own single unique and valid barcode coupon. (Figure 1 to Figure 8) Consent to scan fingerprint Scanning of fingerprint and Verification of Fingerprint (Figure 9 to Figure 14) Screen participant for Eligibility with Eligibility Questionnaire. (Figure 15 to Figure 20) Note: Individuals who come without coupons to the study site cannot be enrolled into the study. They can only enroll if they receive a coupon from a peer who has already participated in the study. If a recruit (who has a valid coupon) comes to the study site with one or more of their friends, who they would like to also like to recruit into the study, follow these steps: If waiting room queue is not long: Ask these friends to wait until their friend with the coupon has completed the study. After the recruit is issued with his invitation coupons they can be given to the friends, the friends can now participate in the study. If there is a long queue for the study: Enforce the validity on the coupon. Figure 1 Validating the coupon with BRYANT System. These are the steps required to start recording each participant in the RDS study. The screener needs to log onto the BRYANT System via http://www.bryantresearchsystems.com/ (Figure 1)

5. Created by © BRYANT Research Systems 2012 4 Figure 2 Enter your Screener User Name, Password and Site Code into green LOGIN Box and click on LOGIN. (Figure 2). Figure 3 The Screener will be logged into the MAIN MENU. (Figure 3) The Screener ONLY has access to the Capture Participant Function. Unless the Screener logs off the Screener will continue to capture participants from the MAIN MENU page Screener will click on HERE to proceed. (Figure 3)

6. Created by © BRYANT Research Systems 2012 5 Figure 4 To verify the coupon the Screener will click on Capture Participant icon. (Figure 4) Figure 5 Check that the barcode on the participant coupon to see if it is valid for the study site. (Figure 5).

7. Created by © BRYANT Research Systems 2012 6 Figure 6 Scan the barcode into the Scan Barcode box (Figures 6). If the barcode is scanned in it will be automatically submitted Figure 7 The BRYANT System will automatically validate the Barcode of the participant. If the coupon is valid the BRYANT System will proceed to the Biometrics Consent Form (Figure 7) The page will reflected – VALID PARTICIPANT Consent for Biometrics:See printed form. Screener will take the participant through the consent form and see that it is completed. If the participant agrees to consent then select. Participant has AGREED and signed the form. If the participant has not given consent then select. Participant does NOT AGREE and has NOT signed the form. Click on Submit

8. Created by © BRYANT Research Systems 2012 7 Figure 8 The following screen will appear on submitting the biometric consent to verify that you have submitted the correct selection. (Figure 8 ) Please check to see that you have made the correct selection. If you have selected NOT AGREE the participant will become ineligible Participant does NOT AGREE and has NOT signed the form. Figure 9 Select OK if it is correct (Figure 9)

9. Created by © BRYANT Research Systems 2012 8 Figure 10 If the participant declines consent the following screen will appear. (Figure 10) Participant has declined Biometrics. Participant may not proceed. Escort the participant to reception. Provide relevant materials Keep the participant coupon. Mark as Declined Consent Figure 11 If you scan the coupon barcode again the following screen will appear in the Participant Progress Tracking (Figure 11) BIOMETRICS DECLINED. PARTICIPANT NOT ELIGIBLE FOR THIS STUDY Ineligible

10. Created by © BRYANT Research Systems 2012 9 Figure 12 The following screen will appear on submitting the biometric consent to verify that you have submitted the correct selection. (Figure 12) Please check to see that you have made the correct selection. If you have selected AGREED the participant will eligible Participant has AGREED and signed the form. Figure 13 Select OK if it is correct (Figure 13)

11. Created by © BRYANT Research Systems 2012 10 Figure 14 If the participant gives consent the Enroll Biometrics screen will appear. (Figure 14) The process of taking the fingerprint scan will start by clicking on Enroll Figure 15 If an invalid Barcode is scanned the screener will be notified by text appearing on his screen (Figure 15) The barcode (XYZABCC)you have scanned does not belong to this study site. Try Again! The Barcode can be scanned again. If the coupon has been damaged Screener can manually type in Barcode number to verify its validity. If the Barcode is invalid, tell the participant that they have an invalid barcode and that they are not able to participate in the sudy and escort the particiant to reception. Mark the coupons as INVALID

12. Created by © BRYANT Research Systems 2012 11 Figure

13. Created by © BRYANT Research Systems 2012 12 III. SCANNING THE FINGERPRINT The fingerprint scan is taken to ensure participants are not duplicated and when they return to the site they can be verified as the participant presenting their coupon. It is important that the screener takes their time in enrolling the fingerprint. All participants had fingerprints scanned generating a unique alphanumeric code with no image recorded. The code cannot reconstruct the fingerprint image but upon re-scanning, the same code is generated. Purpose: Verifies eligibility by creating a unique alphanumeric code Protect the participant on returning visits from getting the wrong information or test results. Ensure the right person is compensated or asked to provide additional information on return visits If the fingerprint is in the database already consult with Study Coordinator to make the recruit ineligible due to prior participation or inability to verify the fingerprint. Say to recruit: It appears that the computer cannot verify your fingerprint and because of this we can NOT enroll you to participate. [provide referrals and harm reduction materials, Return the participant coupon to the Coupon Manager and void the coupon. Figure 16 Use of fingerprint scanning Fingerprint scanning is used to detect duplicate recruits (participants presenting again with another coupon); to link return visits with initial visits; and to link various survey procedures within the same visit. Fingerprint and Fingerprint Scanner

14. Created by © BRYANT Research Systems 2012 13 THE FOLLOWING STEPS NEED TO BE TAKEN BY THE SCREENER TO ENSURE A VALID FINGERPRINT SCAN IS COLLECTED. Check the Left and Right thumb print. See which has the best print. Take your time. The finger must cover the screen completely as shown below. Follow the instructions on the screen Do not swap fingers until the screen says so. Figure 17 The process of taking the fingerprint scan will start by clicking on Enroll (Figure 17) Wrong Correct

15. Created by © BRYANT Research Systems 2012 14 Figure 18 The BRYANT System will send a message to make sure fingerprint is captured is correctly. (Figure 18) Screen will show the following script: Futronic Fingerprint Ready Place first finger on Fingerprint Scanner, first scan Please ensure that the finger is placed correctly on fingerprint the scanner. Participant could become ineligible if poor or improper scanning of the finger to gain a fingerprint scan Figure 19 Screen will show the following script: Futronic Fingerprint Ready FingerDown Enrollment Started Enrollment Not Finished Put your First finger again. FingerUp Place first finger on Fingerprint Scanner, second scan

16. Created by © BRYANT Research Systems 2012 15 Figure 20 Figure 21 Screen will show the following script: Futronic Fingerprint Ready FingerDown Enrollment Started Enrollment Not Finished Put your First finger again. FingerUp FingerDown Enrollment Not Finished Put your First finger again. FingerUp Place first finger on Fingerprint Scanner, third scan The screen will continue if Enrollment Not Finished Put your First finger again. FingerUp The BRYANT System will send a message to make sure first fingerprint is captured is correctly. (Figure 21) Screen will show the following script if the first finger enrolment is complete: First Finger Complete. Place second Finger ------------------------------------------ FingerUp Make sure that the screen shows First Finger Complete. Place second Finger script before starting the enrolment of the second finger. If screener does not observe this the participant could become ineligible due to incorrect enrolment

17. Created by © BRYANT Research Systems 2012 16 Figure 22 Screen will show the following script: First Finger Complete. Place second Finger ------------------------------------------ FingerUp FingerDown Enrollment Started Enrollment Not Finished Put your Second finger again. FingerUp Figure 23 Screen will show the following script: First Finger Complete. Place second Finger ------------------------------------------ FingerUp FingerDown Enrollment Started Enrollment Not Finished Put your Second finger again. FingerUp FingerDown Enrollment Not Finished Put your Second finger again. FingerUp

18. Created by © BRYANT Research Systems 2012 17 Figure 24 Screen will show the following script: First Finger Complete. Place second Finger ------------------------------------------ FingerUp FingerDown Enrollment Started Enrollment Not Finished Put your Second finger again. FingerUp FingerDown Enrollment Not Finished Put your Second finger again. FingerUp Figure 25 The BRYANT System will send a message to make sure Enrolment is complete. (Figure 25) Screen will show the following script if the enrolment is complete: Enrolment complete. Thank you Click on OK

19. Created by © BRYANT Research Systems 2012 18 Figure 26 Enrollment complete, thank you. (Figure 26) Figure 27 The BRYANT System will send a message to make sure Enrolment is complete and that the fingerprint needs to be verified. (Figure 27) The screen will display the following script: Enrollment complete, thank you. ----------------------------------------- Place finger again to verify fingerprint. FingerUp Place the first finger scanned and place it on the scanner again to verify the fingerprint.

20. Created by © BRYANT Research Systems 2012 19 Figure 28 The BRYANT System will send a message for a VALID NEW participant. (Figure 28) The screen will display the following script: Enrollment complete, thank you. ----------------------------------------- Place finger again to verify fingerprint. FingerUp VALID NEW participant FingerUp Click on OK Biometric fingerprint registration and validation will be complete and the BRYANT System will proceed to the following page Figure 29 The BRYANT System will open on the Participant Progress Tracking page and reflect ELIGIBILITY PENDING. (Figure 29) Click on to proceed with participant eligibility.

21. Created by © BRYANT Research Systems 2012 20 Figure 30 The BRYANT System will send a message for a Participant not eligible to participate in Study! (Figure 30) If participant ineligible the following screen will appear: Enrolment complete. Thank you. ----------------------------------------- Place finger again to verify fingerprint FingerUp FingerDown FingerUp Participant not eligible to participate in Study! Click on OK Figure 31 The BRYANT System will Invalidate the coupon (Figure 31) Keep the participant coupon and mark as invalid Escort participant to reception Provide participant with relevant materials with regards to study/HIV

22. Created by © BRYANT Research Systems 2012 21 Figure 32 The BRYANT System will open the following g page if an invalid coupon is scanned into the scan barcode box (Figure 31)

23. Created by © BRYANT Research Systems 2012 22 IV. SCREENING ELIGIBILITY WITH THE ELIGIBILITY QUESTIONNAIRE The Screener needs to access the Eligibility Questionnaire to assess participant eligibility. (Figure 33) Strict application of eligibility criteria The screening interview is face-to-face, each eligibility question must be asked exactly as written. Go through the entire screening questionnaire. All questions need to be answered by the participant to be eligible to the study. Questions will also be asked to asses the participants network size. The BRYANT System will inform the screener if the participant is eligible or not. (Figure ) If recruit doesn’t meet the eligibility criteria Read “The computer has determined that you are not eligible for this study” Be courteous and explain the recruit that they cannot participate in the study. There is no interview or specimen collection. The BRYANT System will save the eligibility data in System Data Base. (Reimburse him for transport only). There are also no coupons issued for peer recruitment. The study ends here for this recruit. Escort the participant off the site. His recruiter will NOT get reimbursed for this failed recruitment. The Coupon will be made VOID by the System. Retain the Coupon and place in the file of ineligible participants. The screener needs to ask participant which language they would like the eligibility questionnaire to be administered in. Please note this cannot be changed after they have started on the questionnaire. The Screener administers the screening interview to assess eligibility with the Eligibility Questionnaire. Each question is answered by selecting the choices available (A) and then submitted by clicking on Submit this Question (B). (Figure 16 ) The Screener needs to be vigilant to participants who are not eligible to the study who return with coupons they obtain elsewhere. The Screener should also take notice of participants who try to duplicate themselves and returning with invitation coupons or coupons received from other participants. Once a fingerprint is on the System it will prevent duplication or registration of a participant.

24. Created by © BRYANT Research Systems 2012 23 Figure 33 Screener needs to click on the eligibility button (Figure 33) Figure 34 The Screener will select the language that the eligibility questionnaire will be asked in. (Figure 34) The language cannot be changed once the questionnaire has been started so ensure the correct language is selected before answering any questions. Click on the language choice.

25. Created by © BRYANT Research Systems 2012 24 Figure 35 The Screener administers the screening interview to assess eligibility with the Eligibility Questionnaire. Each question is answered by selecting the choices available (A) and then submitted by clicking on Submit this Question (B). (Figure 35) Figure 36 The Screener administers the screening interview to assess eligibility with the Eligibility Questionnaire. Each question is answered by selecting the choices available (A) and then submitted by clicking on Submit this Question (B). (Figure 36) A B

26. Created by © BRYANT Research Systems 2012 25 Figure 37 The BRYANT System will inform the Screener if the participant is NOT ELIGIBLE (Figure 17) or ELIGIBLE (Figure 37) Status: Participant not eligible for this study. Figure 38 ELIGIBLE (Figure 38) Status: FULLY ELIGIBLE

27. Created by © BRYANT Research Systems 2012 26 Figure 39 If the participant is ELIGIBLE Screener can proceed by clicking on Print Folder Barcodes to be affixed on all participants tracking form and research survey materials. (Envelope, Tracking Form, Consent Form for Questionnaire, Consent Form for DBS, DBS Envelope & DBS Sample) (Figure 39) Figure 40 Click on Print Folder Barcode to print labels to be attached on Study materials (Figure 40)

28. Created by © BRYANT Research Systems 2012 27 PARTICIPANT TRACKING SHEET Tracking Sheet Affix the Barcode on the Tracking Sheet. (Figure 21) The participant is handed their Tracking Sheet and Envelope and then escort the participant to the Interviewer. Template in Appendix A DATE: Coupon number or X Recruiter ID □ Eligibility questions/screening □ Network size questions □ Consent for Questionnaire □ Questionnaire Completed □ Consent for LAB Sample □ LAB Sample Provided □ HCT or VCT □ Recruitment Training □ Recruitment Coupons Issued □ Incentive Paid □ Notes: Time and Date Stamp: Entered into Data Base:

29. Created by © BRYANT Research Systems 2012 28 V. INTERVIEWER The Interviewer is responsible for obtaining participants consent to participate in Research Study. Obtaining informed consent Review the main study procedures i.e., that there is an interview, laboratory testing, peer recruitment, incentive, and 2nd visit, and probe if the participant has any questions. Ask if he is willing to take part. Note the participant’s decision (yes or no) on the BRYANT System. Recruit must agree to all elements of the study to consent. Participant must sign a copy of the consent form. The signed copy must be placed in the participant’s envelope. Provide copy of consent to participant. Note that participant consented by ticking and putting Interviewer initials on the Tracking Form. If the recruit refuses consent Document the refusal on the BRYANT System, the Tracking Form and consent form. Thank him for coming. Escort the participant to the Coupon Manager (reimburse for transport only) and end all activities here. No coupons are issued for peer referral. His recruiter will NOT get reimbursed for this failed recruitment.

30. Created by © BRYANT Research Systems 2012 29 Figure 41 Steps needed for Interviewer to take to ensure participant completes the Research Study Questionnaire. The Interviewer needs to log onto the BRYANT System via http://www.bryantresearchsystems.com/ (Figure 41) Figure 42 Enter your Interviewer User Name, Password and Site Code into green LOGIN Box and click on LOGIN. (Figure 42)

31. Created by © BRYANT Research Systems 2012 30 Figure 43 The Interviewer will be logged into the MAIN MENU. (Figure 43) The interviewer ONLY has access to the Questionnaire Figure 44 Interviewer will click on Questionnaire Icon to proceed. (Figure 44)

32. Created by © BRYANT Research Systems 2012 31 Figure 45 The Questionnaire Scan in Participant Page will open. (Figures 45). Interviewer will click into the Scan Barcode box and then scan in the Barcode on the participant Tracking Form. If the barcodes do not scan properly please inform the Site Manager or the Screener immediately. Figure 46 The Questionnaire Language Selection Page will open. (Figures 46). Interviewer will click on the language the participant is comfortable with. Participant must be comfortable and be able to understand the language selected This will select the appropriate AWEBSI for the participant

33. Created by © BRYANT Research Systems 2012 32 Figure 47 The Interview Consent Form Page will open. (Figure 47) Interviewer needs to read the Consent Form to the participant and probe if the participant has any questions. (Follow Research Study Site Protocol with regards to Obtaining Consent.) Ask if he is willing to take part. Select the participant’s decision (AGREED or NOT AGREED) on the BRYANT System. o Recruit must agree to all elements of the study to consent. o Participant must sign a copy of the consent form. o The signed hard copy must be placed in the participant’s envelope. Provide hard copy of consent to participant. o Note that participant consented by ticking and putting Interviewer initials on the Tracking Form. Figure 48. If the recruit refuses consent the Interviewer needs to document the refusal on the BRYANT System by clicking on Participant does NOT AGREE and has NOT signed the form (A). The Submit button (B) needs to be clicked to complete process. (Figure 48) The Tracking Form needs to reflect that consent has been declined and initialed. Thank participant for coming. Escort the participant to the Coupon Manager (reimburse for transport only) and end all activities here. No coupons are issued for peer referral. His recruiter will NOT get reimbursed for this non eligible recruitment. A B

34. Created by © BRYANT Research Systems 2012 33 Figure 49 The System will verify by asking; Are sure you have selected correctly. Click Cancel if you are not sure. (Figure 49) By clicking OK the participant will become ineligible. Figure 50 By clicking OK the participant will become Ineligible. (Figure 50) The participant will not be able to continue with the Research Study

35. Created by © BRYANT Research Systems 2012 34 Figure 51 If the recruit consents to participate in the research study the Interviewer needs to document it on the BRYANT System by clicking on Participant has AGREED and signed the form. (A) The Submit button (B) needs to be clicked to complete process. (Figure 51) The Tracking Form needs to reflect that consent has been agreed and initialed by Interviewer. Thank participant for agreeing to participate in the Study. Figure 52 The System will verify by asking; Are sure you have selected correctly. Click Cancel if you are not sure. (Figure 52) By selecting OK the participant will become eligible to participate in the research study Questionnaire. A B

36. Created by © BRYANT Research Systems 2012 35 Figure 53 The System will go to the Questionnaire Scan Participant when a participant is Eligible. (Figure 53) The option to Run Trial Questionnaire (tick the checkbox) Scan participant barcode Figure 54 Select the language for the trial questionnaire. (Figure 54)

37. Created by © BRYANT Research Systems 2012 36 Figure 55 Participant is able to complete the trial questionnaire with the interviewer present. (Figure 55) Figure 56 On completion of the Trial Questionnaire the BRYANT System will return to the Questionnaire Scan Participant (Figure 56)

38. Created by © BRYANT Research Systems 2012 37 Figure 57 Scan in participant barcode (Figure 57) Figure 58 BRYANT System will ask Are you sure you want to run MAIN Questionnaire! Click Cancel if you want to run TRIAL Questionnaire and tick the checkbox. Click OK if you want to continue with main questionnaire.

39. Created by © BRYANT Research Systems 2012 38 Figure 59 Select the language the participant would like to use Figure 60 Participant then administers the questionnaire on their own. Interviewer can observe and offer assistance if required.

40. Created by © BRYANT Research Systems 2012 39 Figure 61 If the following screen appears the participant is ineligible and needs to be escorted to Coupon Manager or Site Manager Questionnaire successfully submitted! Please call the Interview Facilitator! There are a number of questions in the main questionnaire that screen for eligibility. If a participant has given the wrong response they become ineligible. Figure 62 If the participant completes the questionnaire the following screen will appear. Questionnaire successfully submitted! Thank the participant for completing the questionnaire and then escort them to the HCT counselor to continue with the Study and to provide a DBS sample. If the participant Tracking Sheet Barcode is scanned again it will show that the Form already submitted. (Figure ) If the participant declines to provide a DBS the participant is escorted to the Coupon Manager.

41. Created by © BRYANT Research Systems 2012 40 Figure 63 If the participant Tracking Sheet Barcode is scanned again it will show that the Form already submitted. (Figure 63 - 65 ) Figure 64

42. Created by © BRYANT Research Systems 2012 41 Figure 65 Form already submitted!

43. Created by © BRYANT Research Systems 2012 42 VI. HCT COUNSELOR The HCT Counselor is responsible for obtaining participants consent to providing a DBS sample for the Research Study and offering HTC. Obtaining informed consent Review the main study procedures i.e., laboratory testing and providing an opportunity for a Voluntary Testing to find out their Status and probe if the participant has any questions. Ask if he is willing to take part in providing a DBS. Note the participant’s decision (yes or no) on the Tracking Sheet. Recruit must agree to all elements of the DBS study to consent if they wish to provide a DBS sample. If the recruit consents to participate o Participant must sign a copy of the consent form. o The signed copy must be placed in the participant’s envelope. o Provide copy of consent to participant. o Note that participant consented by ticking and putting Counselor initial on the Tracking Sheet. o Participate in the DBS Sample Study by having his finger pricked and providing a small sample of blood. o Ensure a large enough blood sample is taken o Barcode affixed to DBS Blotter and DBS envelope. o Note that participant provided DBS by ticking and putting Counselor initial on Tracking Sheet. o Participant will be eligible for DBS incentive. o Ask if participant would like to test for HIV. Offer to take a rapid test. Tell the participant to return after completing their visit to the Coupon Manager to have counseling and to receive their results. If the recruit refuses consent for DBS o Document the participant refusal on the Tracking Form and consent form. Thank him for coming. o Escort the participant to the Coupon Manager (participant will be paid the incentive for completing the Questionnaire only) and end all activities here. o Inform the participant that they are welcome to return at a later date if they wish to know their status via the HCT. o Participant Recruiter will be eligible for incentive for recruiting participant and participant is eligible to recruit peers if the Questionnaire was completed successfully. On completion of the DBS the participant can be escorted to the Coupon Manager. The HCT Counselor can log onto the BRYANT System to record their HCT records.

44. Created by © BRYANT Research Systems 2012 43 VII. ADMINISTERING PARTICIPANTS IN RESEARCH SITE Main events at the Administering stage and Coupon Managers role is: Verification of participants Tracking Form - Each recruit must complete the process by come with their own single unique and valid barcode coupon. Provide Peer Recruitment Training to participants eligible to recruitment coupons. Print out Recruitment Coupons to eligible recruiters Pay out Incentives

45. Created by © BRYANT Research Systems 2012 44 Figure 66 Validating the Tracking Form or coupon with BRYANT System. These are the steps required to start recording each participant in the RDS study. The Coupon Manager needs to log onto the BRYANT System via https://www.bryantresearchsystems.com/ (Figure 66) Figure 67 Enter your Coupon Manager User Name, Password and Site Code into green LOGIN Box and click on LOGIN. (Figure 67)

46. Created by © BRYANT Research Systems 2012 45 Figure 68 The Coupon Manager will be logged into the MAIN MENU. (Figure 68) The Coupon Manager will only have access to the Administer Participant icon and Participant Information icon. Figure 69 To verify the coupon the Coupon Manager will click on Administer Participant icon. (Figure 69)

47. Created by © BRYANT Research Systems 2012 46 Figure 70 Coupon Manager will click into the Scan Barcode box and then scan in the Barcode on the participant coupon. (Figure 70) Figure 71 Coupon Manager will click on 1st Visit Checklist. (Figures 71)

48. Created by © BRYANT Research Systems 2012 47 Figure 72 The BRYANT System will open on the First Visit Checklist. (Figure 72) The Coupon Manager will verify the details on the Tracking Form on the System: (A) o Check to see that consent has been obtained to participate in Questionnaire. o Insert who carried out the Questionnaire Interview. o Check to see that consent was obtained for DBS o If no consent was obtained to insert the Reason DBS not carried out. Figure 73 Click on Submit. (B) (Figure 73) A B

49. Created by © BRYANT Research Systems 2012 48 Figure 74 The System will ask if Coupon Manager is SURE the form is correctly completed and to verify the details by clicking OK. (Figure 74) Figure 75 By clicking OK the form will be submitted and a participant Barcode with Date and Time label will be automatically printed. (Figure 75) This can be affixed onto participant envelope to assist in collating participants Research Data on site for easy reference. By Clicking on OK the Participant Progress Tracking will allow the Coupon Manager to issue Coupons. The Coupon Manager needs to establish whether the participant is eligible to recruit other participants.

50. Created by © BRYANT Research Systems 2012 49 VIII. PEER RECRUITMENT INSTRUCTIONS (Q & A) Q: Who gives instructions to recruiters on how to recruit? A: Preferably, Only coupon managers provide such instructions to recruits. In rare cases, the project manager or principal investigator can provide instructions as well. Q: How many coupons should I give out? A: The project manager will provide guidance on this. The number of coupons may change over time. Most of the times it is 3 coupons per recruit. Later in the survey, we may hand out only 1, and towards the end, 0 coupons. In some rare cases recruiters may get more than three coupons. This will be decided by the PI and Project Manager. Q: Can I give a coupon from the MSM study to someone who is not MSM? A: No. MSM should only recruit MSM. Q: What points shall the Coupon Manager discuss with the recruiter? A: - Which people to recruit - What to tell the peers about the survey Q: Which people should recruiters consider for recruiting? A: Recruiters should only give the coupons to people they know Recruiters should be confident that these peers are members of their own MARP group Q: Who should recruiters not give a coupon to? A: Recruiters shouldn’t give coupons to: - Strangers (even if otherwise eligible) - People who are not a member of the same MARP group - People who do not live in and around Nairobi - People who are less than 18 years old

51. Created by © BRYANT Research Systems 2012 50 Q: Can recruiters give coupons to family members, sex partners, or other people they are very close to? A: Yes, all people they know personally and who are members of the same MARP can be given coupons. Q: How should recruiters choose among the people they know? Should they give preference to certain peers? A: Explain to them that ideally, they choose randomly among the people they know, and who are also members of the MARP Another way of “choosing” peers is to hand out the coupon on a first come first serve basis, i.e., the first eligible peer they know personally and meet after receiving the coupon. In any case, don’t encourage a recruitment pattern based on other factors, such as the closeness of their relationship to them, or someone who wants to test, or wants an incentive, etc... Q: Can recruiters give more than one coupon to the same person? A: No. If a recruit shows up at the survey office with 2 or more coupons, we will retain all coupons, use only one, and declare the other coupons invalid. There also cannot be a double incentive for having 2 coupons. (CM should write VOID across the face of the coupon and file in the VOID coupon). Q: Can a recruiter photocopy a coupon to recruit extra people? A: No, only original coupons can be used. Photocopied coupons are invalid. Q: What should the recruiter tell the potential future recruit? A: The recruiter should tell his/her peer what the survey is about, and what can be expected. They should emphasize the benefits of taking part and what a good experience it will be. - free anonymous HIV testing, - testing for several other sexually transmitted diseases, - referral for care and treatment if they test HIV-positive, - referral for treatment or on the spot treatment if they have another sexually transmitted infection, - counseling on how to stay healthy, - a safe non-judgmental environment - no names recorded

52. Created by © BRYANT Research Systems 2012 51 Q: Should the recruiter keep a copy of the coupon or a portion of the coupon? A: No, the whole coupon should be given to the peer. We know in our database who was given which coupon (number). If the recruiters want to note down for themselves which coupon (number) they gave to whom, they can do that. Q: What if the peer tells the recruiter that s/he has just tested for HIV anyway, or if they say they know they’re infected or on treatment already? A: Prior HIV testing, regardless of the test result, has nothing to do with eligibility for this survey. All people can join as long as they meet the eligibility criteria, regardless whether they previously went for a test or not, whether they are HIV-infected or not, or already on treatment with ARVs or not. The recruiter should explain to the peer that this survey is not just about HIV. By participating they can learn how to stay safe and healthy. We also offer tests for other important diseases and provide treatment for these. If not yet under care, we refer HIV-infected persons to health care providers who will give them care and treatment as necessary. If they tested negative before it’s worthwhile to test again. Q: What should I tell the recruiter about the secondary incentive? A: Tell the recruiter that we appreciate his/her help in recruiting. To show this appreciation we will give them a little money (tell them how much) at the 2nd visit for each recruit they refer to us and who joins the survey. We cannot give them an incentive if: - the coupon does not find its way back to us - the coupon holder is not eligible By the time the recruiter comes back for his/her 2nd visit we hope to already know how many eligible recruits they referred to us and will pay out the secondary incentive accordingly. Q: If, at the time of the recruiter’s 2nd visit no coupon was redeemed, can the recruiter get a “2nd chance” and be given some more coupons and try again? A: As a general rule, no, there is no “2nd chance”. Only the Site Coordinator can make an exception. If the Site Coordinator decides to allow replacement coupons. Q: What if a coupon holder comes to the office only after the recruiter’s 2nd visit? A: That is totally ok! The recruiter will have to come back another time to get paid for this recruit.

53. Created by © BRYANT Research Systems 2012 52 Q: What if the coupon holder says that s/he wants to collect the recruiter’s secondary incentive, perhaps to save him/her to come to the office again? A: Only recruiters can be paid for their own recruitment. Figure 76 ISSUING COUPONS TO PARTICIPANTS Coupon Manager clicks on Print Invitations to print participant invitation Barcodes (Figure 76)

54. Created by © BRYANT Research Systems 2012 53 Figure 76 The BRYANT system will open on Invitation Coupons Page. (Figure 76 ) Click on Print Invitations. Printer will print out Barcode Labels. The Barcodes Labels can be affixed onto the coupons. Figure 77. INSERT COUPON Click on Continue to return to the Participant Progress Tracking. (Figure 77)

55. Created by © BRYANT Research Systems 2012 54 Figure 78 Click on Continue to return to the Participant Progress Tracking. (Figure 78) Figure 79 Participant Progress Tracking will show participant progress and completed steps in the participants Administration. (Figure 79)

56. Created by © BRYANT Research Systems 2012 55 IX. SECONDARY INCENTIVE PAYMENT INSTRUCTIONS - Only the coupon manager or site coordinator can provide reimbursements. - Pay the exact reimbursement amount. Every morning, the coupon manager needs to ensure they have vouchers on hand. Alert the site coordinator or project manager before you run out of vouchers. - All vouchers handed out need to be accounted for. There is a form that lists the Participant ID number and voucher issued. The person issuing the vouchers (usually the coupon manager) and the recruit initial for each amount paid. - Reimbursement is at the end of the visit after all events have taken place. No advances are paid, and no vouchers can be “loaned” until the next visit. - Participants will not be reimbursed for visits beyond 2nd visit, unless they need to return because their results were not ready. Table. 1. Re-imbursement item Amount ### R Transport for ineligibles Primary Transport to and from clinic Interview time at clinic 50 Counseling and testing time 50 Subtotal Primary 100 Secondary Transport to and from clinic, interview Max. recruitment (recruiting ≤3 peers, at R 30 each) 90

57. Created by © BRYANT Research Systems 2012 56 Figure 80 INCENTIVE PAYMENT INSTRUCTIONS The Coupon Manager needs to open up the Participant Tracking Page. (Figure 80) To pay out Incentives due the Coupon Manager needs to click on Incentives Due button. Figure 81 Click “Verify” (Figure 81) SCAN FINGER

58. Created by © BRYANT Research Systems 2012 57 Figure 82 Select left or right hand and scan a finger to verify their fingerprint. (Figure 82) Figure 83 Verification box will appear with “Participant Verified” (Figure 83)

59. Created by © BRYANT Research Systems 2012 58 Figure 84 Click “OK” to continue (Figure 84) Figure 85 BRYANT System will open on Referral Incentives page(Figure 85)

60. Created by © BRYANT Research Systems 2012 59 Figure 86 INCENTIVE PAYMENT INSTRUCTIONS Incentives page will open with the relevant tick boxes for each incentive due (Figure 86) Figure 87 The Referral Incentives Page will open. (Figure 87) Referral Description will display which incentives are due Value of Incentive Payment Status - pending

61. Created by © BRYANT Research Systems 2012 60 Figure 88 Tick each incentive due (Figure 88) Figure 89 A reminder box will appear to click the Update Payment Status once they have completed all incentives due. (Figure 89) Tick incentive and then Click Okay

62. Created by © BRYANT Research Systems 2012 61 Figure 90 Tick next incentive amount and click OK (Figure 90) Figure 91 Click on “Update Payment Status” (Figure 91)

63. Created by © BRYANT Research Systems 2012 62 Figure 92 Page will reflect payment (Figure 92) Click on “continue” to return to Admin Page Figure 93 Participant Progress Tracking page will reflect incentives paid. (Figure 93) Click on Contact Details to collect follow up info to recall participants for phase 2

64. Created by © BRYANT Research Systems 2012 63 Figure 94 BRYANT System will open Personal Details page (Figure 94) Coupon Manager to ask participant for their contact details. All data with * is required data. Figure 95 Click “Submit” (Figure 95)

65. Created by © BRYANT Research Systems 2012 64 Figure 96 Click “OK” to submit contact details (Figure 96)

66. Created by © BRYANT Research Systems 2012 65 X. RETURN VISIT Validate Participant All participants returning to the site to collect secondary incentives will proceed to the Coupon Manager who will verify their eligibility. To open a Participant Progress Tracking the Coupon Manager needs to scan participant Barcode by login into the System via Administer Participant. Establish Identity. The system will validate a participant if they are scanned into the System The Verify Biometrics page will open to verify the participant fingerprint. If the System does not validate the participant consult the Site Manager. Determine the return visit reimbursement for the number of peers recruited - At the time of the participant return visit, check BRYANT System to see how many of the recruits of the participant have successfully participated in the study. Successfully means the recruit was eligible and participated in the study. - If it was a successful recruitment, you will see ‘Pending’ next to the coupon #. This means a payment is pending for this coupon #. - If no recruit has participated the System will indicate not yet eligible. - If a recruit showed up but was ineligible the System will indicate ineligible - If a recruit showed up but declined consent the System will indicate consent declined

67. Created by © BRYANT Research Systems 2012 66 Figure 97 Steps to Validate Participant All participants returning to the site to collect secondary incentives will proceed to the Coupon Manager who will verify their eligibility by clicking the Administer Participant button (Figure 97) Figure 98 The Coupon Manager needs to scan the participants Barcode Coupon to establish if it is valid and eligible to log into the Participant Progress Tracking page. (Figure 98)

68. Created by © BRYANT Research Systems 2012 67 Figure 99 The system will verify if Barcode Coupon Valid by going to Participant Progress Tracking (Figure 99) Figure 100 Coupon Manager will Click on Incentives Due (Figure 100)

69. Created by © BRYANT Research Systems 2012 68 Figure 101 BRYANT System will open Verify Biometrics (Figure 101) Click on “Verify” Coupon Manager will scan one finger to obtain a fingerprint scan Figure 102 Verify Biometrics page will show: Futronic Fingerprint Ready (Figure 102) Coupon Manager will scan one finger to obtain a fingerprint scan

70. Created by © BRYANT Research Systems 2012 69 Figure 103 The BRYANT System will display (Figure 103) Click “OK” Figure 104 The BRYANT System will return to Referral Incentives if valid Participant is submitted. (Figure 104) The system will reflect incentives due Recruit was successfully recruited Payment Status will be Pending Recruit has not participated the Payment Status will be not yet eligible Recruit was ineligible the Payment Status will be ineligible. Recruit did not give consent the Payment Status will be Consent Declined Tick Mark as Paid Update Payment Status

71. Created by © BRYANT Research Systems 2012 70 Other The Coupon Manager is the last to see the recruit at return visit. Check against the Checklist to see all necessary events took place: That the peer recruitment interview took place, that the recruit was counseled, received all lab results, treated or received their referral letter as appropriate.

72. Created by © BRYANT Research Systems 2012 71 Figure 74 yes Figure 75 yes

73. Created by © BRYANT Research Systems 2012 0 Appendix A Participant Tracking Sheet DATE: Coupon number or X Initial of Site Staff Recruit UID □ Eligibility Questionnaire / Screening □ Network Size Questions □ Consent for Questionnaire □ Questionnaire Completed □ Consent for LAB Sample □ LAB Sample Provided □ VCT / HCT □ Recruitment Training □ Recruitment Coupons Issued □ Incentives Paid □ Notes: Time and Date Stamp: Entered into Data Base:

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