TRACE INITIATIVE: Overview

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BACKGROUND

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.

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.

As countries move closer to reaching “95-95-95,” real-time monitoring of recent HIV infections will allow targeting of the public health response.

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

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).

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.

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 >>

Limiting Antigen & Antibody Avidity 2012

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

RATIONALE

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)

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

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

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

SENSITIZATION

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

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

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

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

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

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

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

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