CDCs HIV Testing Efforts to Support the National HIV/AIDS Strategy - - PowerPoint PPT Presentation

CDC’s HIV Testing Efforts to Support the National HIV/AIDS Strategy

• M. Christine Cagle, Ph.D.

Associate Director for Policy, Planning and Communications Erica Dunbar, MPH Program Leader, Health Department Initiatives Prevention Program Branch Division of HIV/AIDS Prevention National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of HIV/AIDS Prevention

Outline of Presentation

• State of the HIV epidemic in the U.S.
• Importance of HIV testing, linkage to and

retention in care

• CDC HIV testing policies
• CDC HIV testing programs and activities
• HIV continuum of care
• Strategies to improve reach and impact

Magnitude of the epidemic

• 1.2 million people living with HIV
• Each year about
• 50,000 new infections
• 17,000 deaths among people with AIDS
• Net increase of 33,000 people with HIV
• People who start ART are expected to live at least an

additional 35 years

CDC surveillance reports; ART Cohort Collaboration Lancet 2008 3

HIV Prevalence and Incidence

Number of people living with HIV has grown because incidence is relatively stable and survival has increased

200,000 400,000 600,000 800,000 1,000,000 1,200,000 1980 1983 1986 1989 1992 1995 1998 2001 2004 2007 2010

New HIV Infections Prevalence

 Denotes incidence estimates using BED assay

Hall JAMA 2008; PreJean PloS One 2011; MMWR 2011

Faster action saves lives and resources later

Adapted using methods from Hall , et al. JAIDS 2010

• Reducing incidence by 25%
• In 10 years would save 62,000 infections and save $23 billion
• In 5 years would prevent 109,000 infections and save $42 billion

5 1 2 3 4 5 6 1 2 3 4 5 6 7 8 9 10

Stable Incidence 25% reduction in 10 years 25% reduction in 5 years New HIV Infections x 100,000

Years

CDC HIV TESTING POLICIES

• HIV Testing Recommendations for Adults,

Adolescents, and Pregnant Women in Health Care Settings (2006)

– Promote routine, opt-out testing for all persons ages 13-64, not risk-based – Repeat HIV screening of persons with known risk at least annually – Include HIV consent with general consent for care; separate signed informed consent not recommended – Prevention counseling in conjunction with HIV screening not required – 46 states and DC have implemented laws that support recommendations

HIV Testing Policies

• National testing recommendations influence state

laws, but HIV testing laws under state jurisdiction

• Many state testing laws present barriers to

implementation

• State laws should conform or, at a minimum, not

conflict

• To date, only 4 states have incompatible laws

– New York – Massachusetts – Nebraska – Rhode Island

State Testing Laws

JAMA, May 4 (17), 2011

State Testing Laws

JAMA, May 4 (17), 2011

Legislative changes toward compatibility

• f state laws

regarding HIV consent and counseling (2006 CDC Recommendations)

HIV Testing Policies

• Guidelines for Testing in Non-clinical Settings
• Emphasis on targeting, recruitment, and

linkage to care in addition to testing

• Recommendation for retesting
• Forthcoming (2012)
• Guidelines for Supplemental Testing
• New diagnostic algorithm
• Alternative to Western blot
• Detecting Acute HIV Infection
• Forthcoming (2012)

National HIV Behavioral Surveillance System: Infected/Unaware MSM

MMWR (60), 2011

Time since most recent HIV test among MSM who were unaware they were HIV-infected. 21 Cities

Revised Testing Recommendations for MSM

 HIV testing recommended at least annually for persons with

• ngoing risks for exposure to HIV infection

 Recent data suggest more frequent testing for MSM  NHBS (2008)

 19% of sexually active MSM were infected with HIV, but 44% were unaware  Among MSM with undiagnosed HIV infection, 45% had been tested within

the previous 12 months, 29% within the previous 6 months

 Prevalence of undiagnosed HIV among MSM who reported high-risk

behaviors (7%) was similar to that among those who did not (8%)

 Sexually active MSM might benefit from more frequent HIV

testing

 STD Treatment Guidelines - MMWR, December 2010 (59)

CDC HIV TESTING PROGRAMS AND ACTIVITIES

Expanded HIV testing activities

 Expanded Testing Initiative

 2.8 million tests conducted in first 3 years  18,000 people newly diagnosed with HIV; 70% African

American; 12% Latino

 Cost-saving for healthcare system  Provides evidence that large-scale HIV testing programs are

cost-saving and effective

 Newly diagnosed infection rate (0.7%)  Averted an estimated 3,381 HIV infections  Achieved a return of $1.97 for every dollar invested

PS10-10138 Expanded HIV Testing for Disproportionately Affected Populations

 Purpose:

• To sustain progress made under announcement PS07-768
• To expand routine testing services to new clinical venues to

reach a broader array of at-risk populations.

 Target Population:

• African American and Hispanic men and women
• MSM and IDUs, regardless of race or ethnicity

 Grantees:

• Expanded to 30 state, territorial and local health departments

PS10-10138 Funded City and State Health Departments

Number of HIV Tests, Positive Tests, and Positive Test Rates October 2007 – September 2010

Data Source: APR Year 1–3

Total Clinical Settings Non-Clinical Settings Tests Done 2,786,739 2,519,917 (90%) 266,822 (10%) Confirmed HIV+ 29,503 23,546 (80%) 5,957 (20%) New HIV+ 18,432 15,478 (84%) 2,954 (16%) Previous HIV+ 11,071 8,068 (73%) 3,003 (27%) New HIV+ Rate 0.7 0.6 1.1

Venues Funded under PS10-10138 Oct 2010 – Mar 2011

* Includes urgent care clinics, inpatient units, other primary care clinics, pharmacy-based clinics, TB clinics, other public health clinics, dental clinics, and other healthcare settings (n=1,022 venues)

0% 10% 20% 30% Emergency Departments STD Clinics Correctional Facility Clinics Substance Abuse Treatment Facilities Community Health Centers Non Healthcare Settings and CBO Other *

PS11-1113: HIV Prevention for YMSM of color and YTG persons of color

 Purpose:

• Support the development and implementation of effective

community-based HIV prevention programs.

• Increase the number of YMSM of color and YTG persons of color

who are are aware of their HIV status and linked to care, treatment, and prevention services.

• Build the capacity of CDC-funded CBOs delivering structural

interventions, behavioral interventions, and outreach or enhanced HIV testing.

• Ensure provision of HIV prevention and care services.
• Promote collaboration and coordination of HIV prevention efforts

among CBOs, health departments, and private agencies.

YMSM FOA HIV Testing Objectives

 $10 million per year FOA for Young MSM and

Transgender of Color

• Requirement for testing and maintain 4% new diagnoses
• Linkage to care and prevention services for positives and

negatives

YMSM FOA HIV Testing Objectives

 All funded CBOs are required to implement HIV testing with Personalized Cognitive Counseling (PCC).  HIV testing objectives:

• 600-1000 YMSM of color
• 75-150 YTG persons of color

 Approximate number of HIV tests to be conducted:

• 90,000 YMSM of color and YTG persons of color- over

thee 5 year project period  Approximate number of new HIV diagnoses and individuals linked to care and other support services:

• 3,500 YMSM of color and YTG persons of color- over the

5 year project period

Health Department FOA and ECHPP

 Health Department FOA

 Funding distribution determined by number of people

diagnosed and reported to be living with HIV

 Focuses on interventions and strategies that will have

greatest impact on epidemic while allowing flexibility

 Base minimum floor level  Changes in funding distribution implemented over 5 years  Incorporates Expanded Testing Program  Supports innovative programs by Health Departments

 Enhanced Comprehensive HIV Prevention Planning

Project (ECHPP)

 12 jurisdictions with 44% of epidemic  Planning for maximizing impact

Health Department FOA Categories

The following categories are included in the new Health Department FOA: Category A: HIV Prevention Programs for Health Departments (core funding)

Required Core Program Components: HIV Testing, Comprehensive Prevention with Positives, Condom Distribution, and Policy Initiatives Required Programmatic Activities: Jurisdictional HIV Prevention Planning, Capacity Building and Technical Assistance, and Program Planning, Monitoring and Evaluation, and Quality Assurance Recommended Program Components: Evidence-based HIV Prevention Interventions, Social Marketing, Media, and Mobilization, and PrEP and nPEP

Category B: Expanded HIV Testing for Disproportionately Affected Populations (limited eligibility and optional)

Required: HIV Testing in Healthcare Settings Optional: HIV Testing in Non-healthcare Settings Optional: Service Integration

Category C: Demonstration Projects to implement and evaluate innovative, high impact HIV prevention activities (competitive and optional)

Focus areas include 1) structural, biomedical, and behavioral interventions (or any combination thereof), 2) innovative HIV testing activities, 3) enhanced linkages to and retention in care, 4) advanced use of technology, and 5) use of CD4, viral load and other surveillance data to assess and reduce HIV transmission risk.

Four Required Program Components

• HIV testing in healthcare, non health care settings

and venues that target undiagnosed HIV infection

• HIV testing of pregnant women
• Ensure the provision of test results, particularly to

clients testing positive

HIV Testing

• Linkages to care
• Linkages to prevention services
• Partner services
• Interventions for HIV-positive persons
• Integrated screening
• Retention and re-engagement in care

Comprehensive HIV Prevention with Positives

• Target HIV positives persons and persons at risk
• f acquiring HIV infection

Condom Distribution

• Support efforts to align structures, policies, and

regulations in the jurisdiction with optimal HIV prevention, care, and treatment and create an enabling environment for HIV prevention efforts

Policy Initiatives

Category A: HIV Testing Requirements



HIV testing in healthcare settings.



HIV testing in non-healthcare settings.



HIV testing activities in venues that reach persons with undiagnosed HIV infections.



Ensure the provision of test results, particularly to clients testing positive.



Routine, early HIV screening for all pregnant women.



Increase the number of persons diagnosed with HIV through strengthening current HIV testing efforts or creating new services.



Voluntary testing for other STDs (e.g., syphilis, gonorrhea, chlamydial infection), HBV, HCV, and TB, in conjunction with HIV testing, including referral and linkage to appropriate services, where feasible and appropriate and in accordance with current CDC guidelines and recommendations.



Ensure that testing laboratories provide tests of adequate quality.



Incorporate new testing technologies, where feasible and appropriate.

Category A: Comprehensive Prevention with Positives Requirements

 Linkage to HIV care, treatment, and prevention services  Retention or re-engagement in care  Referral and linkage to other medical and social services  Ongoing Partner Services  Necessary interventions and treatment for HIV-positive

pregnant women the prevention of perinatal transmission

 Behavioral and clinical risk screening followed by risk

reduction interventions for HIV-positive persons and HIV- discordant couples at risk of transmitting HIV

Category A: Comprehensive Prevention with Positives Requirements (cont’d)

 Implementation of behavioral, structural, and/or biomedical

interventions

 Integrated hepatitis, TB, and STD screening and Partner

Services for HIV infected persons

 Reporting of CD4 and viral load results, as deemed appropriate  Promote the provision of antiretroviral therapy (ART) in

accordance with current treatment guidelines. CDC funds may not be used to purchase antiretroviral

Category B: Expanded Testing for Disproportionately Affected Populations

The focus of Category B Expanded Testing Program is to expand HIV testing through routine, opt-out testing in healthcare settings, linkages to care, and sustainability of programs (encourage reimbursement for HIV testing). Key components to be conducted and implemented during the project period include the following:

Expanded HIV Testing in Healthcare Settings (required)

Expanded HIV Testing in Non- healthcare Settings (optional) Service Integration (optional)

Expanded and new programs

 “Know Where You Stand” campaign for MSM of all

races

 “Testing makes Us Stronger” campaign for black

MSM

 School-based HIV prevention for young MSM  “Take charge. Take the test.” campaign for African-

American women

 Expanded number and capacity building for DEBIs

 New “Healthy Love” intervention for women  ART adherence and linkage to care

Other DHAP HIV Testing Activities

 HIV testing in pharmacy clinics – expansion of

Expanded Testing Initiative

 MSM Testing Initiative  Walgreens Initiative

 New HIV test algorithm  Study of rapid HIV self-testing among MSM

HIV CONTINUUM OF CARE

Engagement in Care in U.S.

CID , March 15 (52), 2011

CDC Study of Rapid HIV Testing Algorithm (RTA)

 Used to improve accuracy of HIV testing, receipt of

test results, and linkage to care

 CDC study of RTA  Up to 2 additional rapid blood tests  2 reactive rapid tests = same day referral for HIV

care

 Compared with clients who had reactive rapid

test and blood sent for standard (offsite) confirmatory testing

 Los Angeles and San Francisco

Intervention Study Results

 15% of clients who initially received reactive rapid

tests false-positive

 100% of clients with >1 reactive rapid test were positive

 67% of clients received referral engaged in care  100% of positive RTA received referral  47% of clients with laboratory confirmation

received referral

 50% of clients who did not return for confirmatory

results or receive referral still engaged in care

 Imperative that clients are linked to care after

receiving any number of reactive rapid HIV tests

Options for Reactive Rapid Test

• Link to care after initial reactive rapid test
• 1. Conduct RTA
• Link to care with >1 reactive rapid test
• Obtain supplemental test if 1 reactive, 1

negative rapid test

• 2. Obtain specimen for supplemental testing, link to

care after reactive result is confirmed (same as now)

• 3. Link to care after 1 reactive rapid test

Essential ingredient: Linkage to care

CDC Strategies to Improve Reach and Impact

 Focus not only on linkage to care, but retention in

care (and re-engaging patients in care)

 Surveillance data (CD4 count, viral load) will be used

by programs to monitor how many patients are linked to and remain in care

 Require laboratory reporting of CD4 and VL by labs

to states, by states to CDC (without identifying info)

New Testing Algorithm

• New screening tests detect infection earlier than

Western blot

• Most recent (4th generation) tests screen for both HIV

p24 antigen and HIV antibody

• HIV-2 infections can be misclassified as HIV-1 by

Western blot

• Treatment is different: some ARV drugs don’t

work with HIV-2

Window Period Compared with WB and RNA

166 specimens, 17 Seroconverters

Modified from Masciotra et al, J Clin Virol 2011 Days before WB positive WB positive APTIMA RNA (-26) Bio-Rad GS 1/2+O (- 12) Multi-Spot (-7) Reveal G3 (-6) Avioq (+2) OraQuick (-1) Unigold (-2) 25 20 10 5 15 Architect (-20) Clearview COMPLETE (-5) Clearview STAT-PAK (-5) Advia (-14) Vitros (-13)

A1: 3rd or 4th generation HIV-1/2 immunoassay

A2 HIV-1/HIV-2 antibody differentiation test A1(-)

Negative for HIV-1 and HIV-2 antibodies and p24 Ag

A1+ HIV-1 +

HIV-1 antibodies detected Initiate care (and viral load)

HIV-2 +

HIV-2 antibodies detected Initiate care

HIV-1&2 (-) RNA RNA

Acute HIV-1 infection Initiate care

RNA

Negative for HIV-1

Proposed Diagnostic Algorithm

FDA-approved HIV-1/HIV-2 Differentiation Test

Peptide HIV-2 Recombinant HIV-1 Peptide HIV-1 Reactive Control

Conclusions

 Focus on expansion of HIV testing , periodic

retesting for high-risk persons, linking people to care, and making sure they stay in care.

 Surveillance data (CD4 and viral load) will help

programs monitor linkage and care

 4th generation tests and proposed new algorithm

for supplemental testing will detect acute HIV infection (when people are most infectious)

 Proposed new algorithm will also be more

accurate, faster, and less expensive than the Western blot.

For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Place Division name here

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