1. TRACE INITIATIVE: Data Collection Tools and Forms

2. Hello! I am xxx I am here because I love to give presentations.
You can find me at:
@username

3. OVERVIEW OF DATA FLOW

4. Integrating Recency into HTS
HTS Facility
LAB
Routine Testing for HIV at HTC Site (pre-test counseling) Introduce Recency and if feasible consent
Viral load testing
Negative
Positive
(Viral load threshold met)
Confirmatory 2nd HIV test done according to national algorithm (post-test counseling)
Post-test counseling
Final RITA Classification documented and results prepared for facility
Informed Consent Form
Newly identified HIV + consented for recency test
RESULTS
Recent Infection Results Documentation Form
Collect blood to perform RTRI
Laboratory Requisition Form
Return of results tracking log*
Long term infection
Recent Infection
Recent HIV Infection Surveillance Register
Specimen Tracking Log
*If not returning results the documentation in the laboratory is the final step
Specimen for VL prepared for laboratory
Laboratory Specimen Tracking Log

5. Please use either slide 5 or 6 depending on the flow of recency data in your country.

6. Please use either slide 5 or 6 depending on the flow of recency data in your country.

7. DATA COLLECTION TOOLS

8. 1. Informed Consent

9. 1. Informed Consent Form
Are all the fields complete? We cannot use specimens for which we did not obtain completed consent forms.
Conduct the informed consent procedures and complete the signatures page of the consent form (page 2)
Confirm whether the participant consented to recency testing.
Ask the participant to print his/her name, sign, and date. UNLESS if a waiver of consent is obtained from IRB.
Name and signature of person taking the specimen. Date of specimen collection.
If a witness was used, his/her name, signature, and date.

10. 2. Recent Infection Results Documentation Form

11. 2. Recent Infection Results Documentation Form
Purpose:
To capture data for all specimens for which recency testing was conducted
Specimen ID
Visual results
Recency interpretation
To document all recency test results conducted at that facility

12. 2. Recent Infection Results Documentation Form

13. 2. Recent Infection Results Documentation Form
Specify type of test: Asanté or Maxim Swift

14. 2. Recent Infection Results Documentation Form
Specify sample type: Facility level should only have capillary blood (finger prick, top) or venous blood (bottom)

15. 2. Recent Infection Results Documentation Form
JC2102/J8213
Document the kit lot number.
For both test kits, the lot number is found on the foil packaging holding the test strip/cassette.

16. 2. Recent Infection Results Documentation Form
JC2102/J8213
16 Mar 2019 / 08/2020
Document the kit expiry date.
For both test kits, the expiry date is found on the foil packaging holding the test strip/cassette.

17. 2. Recent Infection Results Documentation Form
JC2102/J8213
16 Mar 2019 / 08/2020
Facility name

18. 2. Recent Infection Results Documentation Form
Sample one
JC2102/J8213
16 Mar 2019 / 08/2020
All information for sample one should be recorded in this row.
30/01/2019
For VL Testing

19. 2. Recent Infection Results Documentation Form
Sample one
JC2102/J8213
16 Mar 2019 / 08/2020
Client ID
30/01/2019
For VL Testing

20. 2. Recent Infection Results Documentation Form
Sample one
JC2102/J8213
16 Mar 2019 / 08/2020
30/01/2019
Date of diagnosis
30/01/2019
For VL Testing

21. 2. Recent Infection Results Documentation Form
JC2102/J8213
16 Mar 2019 / 08/2020
Document whether the client consented to recency testing -
If not, do not conduct the recency test

22. 2. Recent Infection Results Documentation Form
JC2102/J8213
16 Mar 2019 / 08/2020
Name of person who conducted the test

23. 2. Recent Infection Results Documentation Form
Results for sample one
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift
Mark if Control Line is present

24. 2. Recent Infection Results Documentation Form
Results for sample one
JC2102/J8213
16 Mar 2019 / 08/2020
VCV
Mark if Verification Line is present
Asante
Swift

25. 2. Recent Infection Results Documentation Form
Results for sample one
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift
Mark if Long-Term Line is present

26. 2. Recent Infection Results Documentation Form
Results for sample one
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
If all three lines are present, the infection is long-term.
Asante
Swift

27. 2. Recent Infection Results Documentation Form
Sample two
JC2102/J8213
16 Mar 2019 / 08/2020
30/01/2019
01/02/2019
01/02/2019
For VL Testing

28. 2. Recent Infection Results Documentation Form
Results for sample two
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift

29. 2. Recent Infection Results Documentation Form
Results for sample two
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Look carefully! The line is faint, but it is there!
Asante
Swift

30. 2. Recent Infection Results Documentation Form
Results for sample two
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift
No LT Line present

31. 2. Recent Infection Results Documentation Form
Results for sample two
JC2102/J8213
16 Mar 2019 / 08/2020
If only the control line and the verification line are present, the infection is recent.
Asante
Swift

32. 2. Recent Infection Results Documentation Form
Sample three
JC2102/J8213
16 Mar 2019 / 08/2020
30/01/2019
01/02/2019
02/02/2019
02/02/2019
For VL Testing

33. 2. Recent Infection Results Documentation Form
Results for sample three
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift

34. 2. Recent Infection Results Documentation Form
Results for sample three
JC2102/J8213
16 Mar 2019 / 08/2020
CVCV
Asante
Swift
No Verification Line present

35. 2. Recent Infection Results Documentation Form
Results for sample three
16 Mar 2019 / 08/2020
JC2102/J8213
CVCV
Asante
Swift
No Long-Term Line present

36. 2. Recent Infection Results Documentation Form
Results for sample three
JC2102/J8213
16 Mar 2019 / 08/2020
Asante
Swift
If the Control line is the only one present, this specimen is HIV negative.

37. 3. Recent HIV Infection Surveillance Register

38. 3. Recent HIV Surveillance Register
L+ = Previous positive
S+ = Self-test positive
No =No previous positive diagnosis
P+ = Previous positive
N+ = Newly positive
N- =Newly negative
L- = Negative
L+ = Positive
Lin =Indeterminate
M=Male
FNP= Female, not pregnant
FP=Female Pregnant
Different from Recent Infection Results Documentation Form:
Client ID number
Indicate whether the client consented to POC test
Sex of client
Age of client
Residence (neighborhood/village) of client
HIV testing history, final diagnosis
Sample collected for VL testing
Known HIV status
Date of last positive HIV test
Information on prior ARV exposure

39. 4. Laboratory Requisition Form

40. 4. Laboratory Requisition Form
To link the patient’s ART number and his/her laboratory results, namely the viral load test results
To document the quality of the specimen during transport from the facility to the laboratory
For tracking of timeliness of lab receipt, processing, and return

41. 4. Laboratory Requisition Form
Sections 1 and 2 to be completed during specimen collection

42. 4. Laboratory Requisition Form
Section 1: Facility-level information
Facility name
HTS Code
Date of HIV diagnosis

43. 4. Laboratory Requisition Form
Section 2: Patient information
ART Number
Specimen Type
Participant ID
Name of staff collecting specimen
Date and time of specimen collection

44. 4. Laboratory Requisition Form
Section 3 to be completed immediately prior to pick-up
But what do these code definitions mean?

45. Specimen Code Definitions

46. Specimen Code Definitions: 1: Acceptable – Not Rejected
DBS
Venous Blood
Participant ID label Can also write ID in space provided
Spots filled in, dried completely
02/02/19
Date of specimen collection
02/02/2019
No hemolysis
Container in good condition

47. Specimen Code Definitions: 2: Broken or cracked container
DBS
Venous Blood
02/02/19
02/02/2019

48. Specimen Code Definitions: 3: Hemolysis
DBS
Venous Blood
This can occur if:
Blood tube is shaken after specimen collection
Blood is not centrifuged within 24 hours of specimen collection
Whole blood is frozen prior to centrifugation
02/02/19
02/02/2019

49. Specimen Code Definitions: 4: Leaking container
DBS
Venous Blood
02/02/19
02/02/2019

50. Specimen Code Definitions: 5: Insufficient blood
DBS
Venous Blood
This can occur if:
Spots are not soaked completely through the filter paper

51. Specimen Code Definitions: 6: Not labeled correctly
Venous Blood
DBS
No ID label
NEVER write participant’s name. Always use Participant ID.
John Doe
Missing date of specimen collection

52. Specimen Code Definitions: 7: Specimen data missing
Venous Blood
DBS
No Participant ID – cannot be linked to other recency data
02/02/2019

53. Specimen Code Definitions: 8: Oversaturation
Venous Blood
DBS
02/02/2019
This can occur if:
Excess blood is applied to the specimen
The entire circle is not uniformly saturated
Blood spots are connected

54. Specimen Code Definitions: 9: Clotted blood
Venous Blood
DBS
02/02/2019
WHAT IS CLOTTED BLOOD

55. Specimen Code Definitions: 10: Scratched spots
Venous Blood
DBS
02/02/2019
This can occur if:
The tip of the finger or capillary tube is dragged across the surface of the filter paper

56. Specimen Code Definitions: 11: Scattered spots
Venous Blood
DBS
02/02/2019
NEEDS TO BE COMPLETED

57. Specimen Code Definitions: 12: Serum rings
Venous Blood
DBS
02/02/2019
This can occur if:
Alcohol is not wiped from puncture site
Squeezing area around puncture site excessively
Drying specimen improperly

58. Specimen Code Definitions: 13: Double-layered spots
Venous Blood
DBS
02/02/2019
This can occur if:
The same circle is touched to the blood drop several times

59. Specimen Code Definitions: 14: Improper drying
Venous Blood
DBS
02/02/2019
This can occur if:
Specimen is not dried for a minimum of 4 hours prior to packaging
Will turn dark red once dry

60. Specimen Code Definitions: 15: Spots that cannot elute
Venous Blood
DBS
02/02/2019
Needs to Be Completed

61. 4. Laboratory Requisition Form
Section 4: Sample Transport to Laboratory (Health Facility Staff)
Name of health facility staff reviewing sample prior to transport
Date of review/date of specimen transport
Time of specimen transport
Initials (signature) of health facility staff reviewing specimen

62. 4. Laboratory Requisition Form
Section 5a: Sample Transport to Laboratory (Courier)
Name of courier reviewing sample after transport
Date of specimen transport
Time of specimen transport
Initials (signature) of courier transporting specimen
Section 5b: Sample Transport to Hub Laboratory (Laboratory Staff)
Name of laboratory staff reviewing sample after transport
Date of specimen arrival at laboratory
Time of specimen arrival at laboratory
Initials (signature) of laboratory staff receiving specimen
Section 5c: Sample Transport to Central Laboratory (Laboratory Staff)
Date of specimen arrival at central laboratory
Time of specimen arrival at central laboratory

63. 5. Specimen Tracking Log

64. Section 1 needs to be completed by health facility staff.
5. Specimen Tracking Log
CVCV
Section 1 needs to be completed by health facility staff.

65. 5. Specimen Tracking Log
The log number is equivalent to the shipment number
Log number does not change based on the number of specimens in shipment
CVCV 1

66. 5. Specimen Tracking Log What date were the specimens sent to the lab?
CVCV 1
02/02/2019

67. 5. Specimen Tracking Log What time were the specimens sent to the lab?
CVCV 1
02/02/2019
13:15

68. 5. Specimen Tracking Log
How many specimens were sent in this shipment?
CVCV 1
02/02/2019
13:15 6

69. 5. Specimen Tracking Log
What was the Participant ID number for each specimen sent in this shipment?
If more than 5 specimens, continue in the second row.
Use a, b, c to confirm the shipment was the same
CVCV 1a
02/02/2019
13:15 6
02/02/2019
13:15 6 1b

70. 5. Specimen Tracking Log
CVCV
Section 2 needs to be completed by person who collected specimen from clinic.

71. Questions? Comments?

72. Thank You!