1. TRACE INITIATIVE: Overview

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3. BACKGROUND

4. 36.7 million 16% decline 45% decline
Global HIV Epidemic
36.7 million
Estimated PLHIV globally, with ~1.8 million new infections having occurred in 2016.
16% decline
In annual new infections between 2010 and 2016.
45% decline
In AIDS-related deaths from 2005 to 2016 due to widespread ART coverage.

5. Estimated PLHIV in [country], with XX million on treatment as of XXXX.
[Insert Country] HIV Epidemic
XX million
Estimated PLHIV in [country], with XX million on treatment as of XXXX.
XX%
Prevalence among adults (age 15-64).
XX%
Annual incidence among adults (age 15-64) or about X per 100 adults get infected each year.

6. As countries move closer to reaching “ ,” real-time monitoring of recent HIV infections will allow targeting of the public health response.

7. Effective Epidemic Control Requires Early Detection and Quick Response
Interrupt further transmission
Target prevention
Analyze data in real time (who/where/why)
Detect Recent Infections
Rapid Test for Recent Infection

8. Laboratory Tests for Recent Infection
Antibody-based tests for recent infection (TRI) can distinguish recent from long-term HIV infection.
Interpretation is challenged by factors that can cause ‘false-recent’ results:
Variable immune responses at the individual-level,
Variable performance of the assay across diverse HIV-1 subtypes and across populations with naturally low viral loads,
Current ART use and advanced HIV disease.
To improve accuracy of interpretation, recent infection testing algorithms (RITAs) incorporate the TRI result with other markers of chronic infection (e.g., low viral load, evidence of treatment).

9. Point-of-Care (POC) Tests for Recent Infection
A POC assay using a single test device provides results within minutes and can simultaneously:
diagnose HIV infection, and
differentiate between recent and long-term infection.
Evaluations of the POC test provide preliminary data on:
diagnostic accuracy of the test, and
mean duration of recent infection detected by the test: ~6 months.
POC tests pave the way for a HIV recent infection surveillance system as part of routine HIV testing services (HTS) to detect and characterize recent HIV infection among newly diagnosed HIV cases.

10. Detecting Recent HIV-1 Infection > Antibody Avidity
Antibody avidity = binding strength of antibody (how strongly HIV antibodies bind to HIV)
Functional property of maturing antibodies
Antibody avidity increases over time after infection
Surrogate marker of time since infection
Can be used to detect and distinguish recently infected persons (weak antibodies) from those with long-term infections (strong antibodies)
Time >>
Antibody Avidity >>

11. Limiting Antigen & Antibody Avidity
2012

12. Recent infection testing among newly diagnosed PLHIV leverages existing systems for added public health and programmatic benefit
National HIV testing algorithm
HTS Client
Routine case finding strategies
National surveillance systems
National M&E systems
Rapid Test 1
Report NEGATIVE
Non Reactive
Reactive
Rapid Test 2
INDETERMINATE
(Follow country guidelines)
Non Reactive
Reactive
Report POSITIVE
Test for recent
infection
Tested
Recent
Tested
Long-term
Supplementary test for recent infection among newly diagnosed
Viral Load Test
Confirmed recent
(Tested recent + VL≥1,000 copies/mL)
Report RECENT

13. RATIONALE

14. Rationale Data on recent infections will be used to:
Strengthen partner notification to reduce number of new HIV infections
Identify areas of high transmission for prevention programming
Strengthen laboratory programs and other interventions in high burden locales to reduce HIV incidence
Generate epidemiologic data to track the epidemic and measure HIV incidence (the rate of new infections)

15. Rationale
Information on recent infections is valuable to patients and partner notification services:
Recently infected individuals have high HIV viral loads and are more likely to transmit the virus to partners
They should be treated as soon as possible to improve their health, and to reduce their risk of transmission to their sexual partner(s) and babies

16. Objectives and Goal First Objective Second Objective Goal
1. Monitor trends in the proportion testing recent on the RITA among newly diagnosed PLHIV by select demographic and HIV risk variables (as available on HIV case reporting form) to inform targeted HIV prevention interventions
Second Objective
2. Identify geographic locations associated with testing recent on the RITA to inform geographic prioritization of HIV prevention interventions
Goal
Use a POC test for recent infection to provide continuous epidemiological data on person, place, and time of newly diagnosed individuals to inform HIV prevention and control strategies

17. Protocol Development
There is a generic protocol: “Establishing HIV-1 Recent Infection Surveillance Using a Point-of-Care Test for Recent Infection among Persons Newly Diagnosed with HIV Infection in [Country]”
15-page protocol
6 appendices:
Informed Consent Form
Example Recent HIV Infection Surveillance Register
Counseling procedures and messages for return of test results
Information Sheet
Statement of intent to maintain confidentiality
Example analysis table shell
Protocol and forms must be tailored to each country

18. SENSITIZATION

19. Sensitization Recent infection surveillance can be used:
To triage partner and index testing to increase the yield of HTS
To identify transmission clusters and develop program and prevention response plans
Monitor success towards reducing new infections
Support case reporting

20. Shift to Case Reporting
Rapid Test for Recent Infection
Can be deployed at HIV testing sites (HTS)
As an addition to the existing national algorithm
Focus on newly diagnosed HIV-positive individuals
Recency data can be compiled and analyzed in real-time
Program: Large number of persons being tested, coupled with index testing, can yield more # of recent infections
Example Country M: 1M tested>10% prevalence>100,000 HIV- Positive>60,000 new diagnosis>3,000 to 6,000 recent infections
Key issue
Deduplication and identifying those 1) with prior diagnosis and 2) on ART
HIV case-reporting system needed with unique ID

21. Shift to Case Reporting
Key Objectives
Identify recent infections (<1 year) among all newly diagnosed HIV-positive persons
Develop a case-based surveillance system for all HIV- positive cases to strengthen recency surveillance
Examine correlates of recent infections describing persons, place, and time
Develop a targeted response for populations with high # of recent infections to interrupt further transmission of HIV
Monitor trends of recent infections over time as a proportion of persons at-risk and newly diagnosed persons

22. Project Update (by country)
Next steps (e.g. protocol development and approval process, procurement, panel preparation and laboratory TOT, implementation, etc.)

23. Project Timeline (by country)
District A
Districts B & C
District D, E, & F
March 10 20 7
April 30 15
May 5 24 16

24. Reporting Context New PEPFAR MER indicator: HTS_RECENT
Percentage of persons aged ≥15 years newly diagnosed with HIV-1 infection who have a test for recent infection result of recent infection during the reporting period
Reporting:
Frequency: quarterly
Level: facility and community
Numerator
Denominator
Number of newly diagnosed HIV-positive persons aged ≥15 years with a test for recent infection result of recent infection during the past quarter
Number of newly diagnosed HIV-positive persons aged ≥15 years with a test for recent infection result during the past quarter

25. Stakeholders’ Roles and Responsibilities
MOH
Owns data, provides technical oversight, provides staff for data collection and testing, and disseminates key findings
CDC and USAID
Provides technical support in design, implementation, analysis and use of findings
Health facilities
Specimen collection and transport
Implementing partners and TA
Support the roll-out
Laboratories
Specimen receipt, testing, and return of results

26. Questions? Comments?

27. Thank You!