White Paper Routine Opt-Out Policy Brief Final 9-10

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Delaware HIV Consortium Policy Committee
Recommendations for Adoption of Routine Opt-Out HIV Testing Procedures for
Adolescents and Adults 13 through 64 in Health-Care Settings
White Paper Policy Brief
HIV is an infectious, preventable disease that remains a leading cause of illness and death in the
United States (U.S.).1 After initial exposure to HIV, a person may show no symptoms of the
disease at all for many years, while the disease advances within the body and can be transmitted
to others. The Centers for Disease Control (CDC) estimates that over 1.1 million people are
living with HIV in the U.S. It further estimates that one in five (21%) infected persons do not
know they have the disease and that these individuals cause the majority of new HIV infections
annually (as much as 54%).2,3
The Role of Blood Testing: While there is no cure for HIV, effective HIV medical treatment can
control the advancement of the disease and help reduce its transmission.4 To get into treatment,
however, people must know their HIV status; and the only way to know one’s status is through
blood testing (also called screening). Research has shown that reliable, inexpensive blood
testing can detect HIV early in its progression, even before symptoms begin. 5 Currently, HIV
blood testing is performed through one of two processes: opt-in testing or routine opt-out testing.
Opt-in HIV testing, the historical process, requires a written consent process and documented
pre-test counseling, requirements that can propose barriers to testing. Routine opt-out HIV
testing, on the other hand, involves performing HIV testing as part of a patient’s routine health
evaluation, without pre-test counseling—similar to screening for other medical conditions—
while preserving the patient’s right to decline testing.6
The Importance Knowing One’s HIV Status: Knowledge of one’s HIV status, coupled with
linkage to medical care and prevention services, provides numerous benefits for those infected
with the disease and for others:
1. By knowing one’s HIV status and initiating early HIV medical treatment, infected
patients can gain years of life and improve its quality.4
2. HIV medications and treatment not only improve the lives of those infected but also
reduce their infectiousness, thus reducing their risk of transmitting the disease to others.4,7
3. Studies have shown that people who are aware of their HIV status adopt behaviors that
reduce HIV transmission to others.8,9
4. Awareness of one’s HIV negative status encourages people to take precautions to remain
HIV negative.10
2006 CDC HIV Testing Recommendations: The CDC has disseminated and revised HIV testing
recommendations over the years in response to extensive research findings on an evolving
epidemic. The CDC last updated its recommendations in 2006, recommending routine opt-out
HIV testing for all adults and adolescent patients 13 through 64 in health-care settings,
including pregnant women, while recommending opt-in testing in all other settings.5 Forty-five

HIV (human immunodeficiency virus) is a life-threatening condition that interferes with the body's ability to fight
off viruses, bacteria and fungi that cause disease. AIDS (acquired immunodeficiency syndrome) is the name given
to the later stages of HIV infection.
Routine HIV Opt-Out Testing Policy Brief
states and the District of Columbia are now consistent with the CDC’s guidelines. 11 In 2009, the
state of Delaware adopted routine opt-out testing for pregnant women only.12
HIV in Delaware: As of August 31, 2010, 3,511 people were living with HIV disease in
Delaware—1,304 with HIV and 2,207 with AIDS.13 These numbers may appear small, but
Delaware is consistently in the top 10 in the nation in terms of annual AIDS incidence per capita
(number of new AIDS infections per year).14 Nationally, 32% of individuals with an HIV
diagnosis reported to the CDC in 2008 received an AIDS diagnosis within 12 months of initial
HIV diagnosis.15 In comparison, Christiana Care Health System (Christiana Care) HIV clinics,
which treat approximately 53% of those in care for HIV disease in Delaware, report that over
50% of those entering its care are immediately diagnosed with AIDS. Christiana Care’s figure
indicates that far too many Delawareans with HIV are discovering their infection even later in
the disease progression and are not getting the important advantages of early treatment, which
also helps reduce transmission. Delaware has a much more positive story to tell regarding
pregnant women. Prior to 2009, the state had been successful in reducing perinatal (mother to
child) transmission through a required offer of HIV screening to pregnant women. In 2009,
Delaware revised its Code to conform with the CDC’s 2006 regulations for pregnant women in
order to further minimize the chances that HIV infection late in the pregnancy would be
missed.12 This action helps Delaware work toward the elimination of perinatal transmission of
HIV for pregnant women who are tested and enter HIV care.
HIV Testing Changes Needed in Delaware: Delaware’s strong public/private partnership of HIV
prevention and treatment providers has been at the forefront in addressing the HIV/AIDS crisis
in Delaware. As HIV disease evolves in Delaware and the sense of urgency associated with it in
early years declines, the state faces new challenges in identifying those with HIV/AIDS,
including those outlined in the first ever National HIV/AIDS Strategy for the U.S., issued July
2010. Two national strategy goals are directly associated with testing—by 2015, reduce the
annual number of new HIV infections by 25%, and increase the percentage of people living with
HIV who know their HIV status from 79% to 90%.4
Legislation has been drafted to amend Delaware’s Code to conform with the CDC’s full 2006
recommendations for HIV testing, plus it adds a required offer of HIV testing of all pregnant
women in their third trimester—not just those at risk.16 The Delaware HIV Consortium Planning
Council, the Consortium’s Policy Committee, and other organizations support these changes, as
outlined herein and in a corresponding White Paper, which provides more detailed justification
for their support. By adopting these changes, Delaware can incorporate routine opt-out HIV
testing into health-care settings, thus identifying those who are HIV positive and linking them
into effective HIV medical treatment as early as possible.
2006 Revised Recommendations for HIV Testing
of Adults, Adolescents, and Pregnant Women in Health-Care Settings
For adult and adolescent patients 13 through 64 in all health-care settings:
 HIV screening is recommended for patients between the ages of 13 and 64 in all healthcare settings after the patient is notified that testing will be performed, unless the patient
declines (opt-out screening).
 Persons at high risk for HIV infection should be screened for HIV at least annually.
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Routine HIV Opt-Out Testing Policy Brief


Separate written consent for HIV testing should not be required; general consent for
medical care should be considered sufficient to encompass consent for HIV testing.
Prevention counseling should not be required with HIV diagnostic testing or as part of
HIV screening programs in health-care settings.
For pregnant women
 HIV screening should be included in the routine panel of prenatal screening tests for all
pregnant women.
 HIV screening is recommended after the patient is notified that testing will be performed
unless the patient declines (opt-out screening).
 Separate written consent for HIV testing should not be required; general consent for
medical care should be considered sufficient to encompass consent for HIV testing.
 Repeat screening in the third trimester is recommended in certain jurisdictions with
elevated rates of HIV infection among pregnant women.
References
1. Centers for Disease Control. MMWR Recommendations and Report, Revised Recommendations for
HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. 2006:2.
2. CDC HIV Surveillance Report: Diagnoses of HIV infection and AIDS in the United States and
Dependent Areas, 2008. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/qu/prevalence.
htm
3. Delaware Division of Public Health, Kennedy J. Speech at Faith Community Partnership Annual
Awards Luncheon. 2/10.
4. The White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United
States.2010:5-7
5. Centers for Disease Control. MMWR Recommendations and Report, Revised Recommendations for
HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. 2006:1-27.
6. Centers for Disease Control. MMWR Recommendations and Report, Revised Recommendations for
HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. 2006:1-9.
7. Donnell, D, Baeten JM, Kiarie J, et. Al. Heterosexual HIV-1 transmission after initiation of
antiretroviral therapy: a prospective cohort analysis. Lancet. 2010.
8. CDC. Questions and Answers for Professional Partners: Revised Recommendations for HIV Testing
of Adults, Adolescents, and Pregnant Women in Health Care Settings: Why should I be tested for HIV?
Available at http://www.cdc.gov/hiv/topics/testing/resources/qa/qa_professional.htm.
9. Centers for Disease Control. MMWR Recommendations and Report, Revised Recommendations for
HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings. 2006:6.
10. CDC. Questions and Answers for the General Public: Revised Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant Women in Health Care Settings: Why should I be tested for HIV?
Available at http://www.cdc.gov/hiv/topics/testing/resources/qa/qa_ general-public.htm
11. Branson, B. CDC - Division of HIV/AIDS Prevention Power Point.
12. Delaware Code. Title 16. Chapter 12. Subchapter I. HIV-Related Tests. SS1204.
13. Delaware Division of Public Health. HIV/AIDS Monthly Surveillance Report. Aug. 2010. Available
at http://www.delawarehiv.org.surveillance.cfm.
14. Delaware Division of Public Health. 2008 Delaware HIV/AIDS Surveillance Report. 2008:1.
15. CDC Factsheet: HIV in the United States: An Overview. Available at: http://www.cdc.gov/hiv/
topics/resources/factsheets/us_overview.htm:4.
16. Draft Bill: An Act to Amend Title 16, Chapter 7 of the Delaware Code Relating to Sexually
Transmitted Diseases and Chapter 12 Relating to Informed Consent and Confidentiality. 2010.
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