TRACE INITIATIVE: Data Collection Tools and Forms

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OVERVIEW OF DATA FLOW

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

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

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

DATA COLLECTION TOOLS

1. Informed Consent

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.

2. Recent Infection Results Documentation Form

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

2. Recent Infection Results Documentation Form

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

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

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.

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.

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

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

2. Recent Infection Results Documentation Form Sample one JC2102/J8213 16 Mar 2019 / 08/2020 3344001 Client ID 30/01/2019 For VL Testing

2. Recent Infection Results Documentation Form Sample one JC2102/J8213 16 Mar 2019 / 08/2020 3344001 30/01/2019 Date of diagnosis 30/01/2019 For VL Testing

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

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

2. Recent Infection Results Documentation Form Results for sample one 3344001 JC2102/J8213 16 Mar 2019 / 08/2020 CVCV Asante Swift Mark if Control Line is present

2. Recent Infection Results Documentation Form Results for sample one JC2102/J8213 16 Mar 2019 / 08/2020 3344001 VCV Mark if Verification Line is present Asante Swift

2. Recent Infection Results Documentation Form Results for sample one JC2102/J8213 16 Mar 2019 / 08/2020 3344001 CVCV Asante Swift Mark if Long-Term Line is present

2. Recent Infection Results Documentation Form Results for sample one 3344001 JC2102/J8213 16 Mar 2019 / 08/2020 CVCV If all three lines are present, the infection is long-term. Asante Swift

2. Recent Infection Results Documentation Form Sample two JC2102/J8213 16 Mar 2019 / 08/2020 3344001 30/01/2019 3344002 01/02/2019 3344002 01/02/2019 For VL Testing

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

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

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

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

2. Recent Infection Results Documentation Form Sample three JC2102/J8213 16 Mar 2019 / 08/2020 3344001 30/01/2019 3344002 01/02/2019 3344003 02/02/2019 3344003 02/02/2019 For VL Testing

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

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

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

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.

3. Recent HIV Infection Surveillance Register

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

4. Laboratory Requisition Form

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

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

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

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

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

Specimen Code Definitions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

5. Specimen Tracking Log

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.

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

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

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

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

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 3344001 3344002 1a 02/02/2019 13:15 6 3344003 3344004 3344005 3344006 02/02/2019 13:15 6 1b

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

Questions? Comments?

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