HIV SCREENING

N501 Midterm October 15, 2013

Myrna Aleman, Christian Boge, Trisha Mckeon, Abby Sorensen, Aura Thomas, Scott Wilson

Statistics on United States HIV Infection and Risk

Populations with more HIV have more riskRisk factors are unprotected sex, drug use

and blood-blood transmissionSocial, economic, demographic factors –

such as stigma, discrimination, income, education, and geographic region affect risk for HIV

More than 1.1 million in US infected

Almost 1 in 5 infected (in US) unaware

50,000 new US infections each year

Young MSM greatest at risk group

13-24-year MSM=72%

new infectionsCDC recommends ALL 13-

64 test for HIVHigh-risk groups should

test more often15,500 with AIDS died in

2010 in US635,000 in US died from

AIDS to date

Effects on Quality and Quantity of life men exhibit poorer physical well-being and level of independence while women report poorer environment social support and spirituality Older people report poorer quality of life on physical and levels of independence while younger people showed poorer environmental and spiritual domains of well-being

Frame Criteria for Health Maintenance

Physical Psychological Social Relationships Environment

Pain and discomfort

Energy and fatigue

Sleep and rest mobility

Activities of daily living

Dependence on medication or treatment

Working capacity

Positive feelings

Thinking and learning

Memory and concentration

Self-esteem

Body image and appearance

Negative Feelings

Spirituality, religion and personal beliefs

Personal relationships

Practical support

Sex

Physical safety and security

Home environment

Financial resources

Health and social care: availability and quality

Opportunities for acquiring new information and skills

Participation and opportunities for recreation and leisure

Physical environments

Transport

With timely diagnosis, access to a variety of current drugs and good lifelong adherence, people with recently acquired infections can expect to have a life expectancy which is nearly the same as that of HIV-negative individuals.

Without treatment lifespan is dramatically reduced

Newer ARV regimens, specifically those currently recommended by the U.S. Department of Health and Human Services (DHHS) for initial therapy, are for most patients, simple, tolerable, and effective. As a result of both the availability of ARV regimens that are less toxic and easier to administer http://aidsinfo.nih.gov/guidelines

DHHS now recommends ART treatment for those individuals whose CD4 count of 500 cells/mm3 and perhaps even upon diagnosis in certain cases. Clients with these CD4 level are often asymptomatic and HIV experts recommend earlier initiation of treatment, and many recommend ART for all willing individuals regardless of CD4 count

The mean per-test cost of rapid HIV testing and counseling was $48.07 for an HIV-negative test and $64.17 for a preliminary-positive test

MSM continue to bear the greatest burden of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected.

The United States Preventative Services Task Force, USPSTF: Clinicians screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened. (Grade A

Recommendation) All Pregnant women, including that who present in labor who are untested and HIV status

unknown. (Grade A Recommendation)

The Center for Disease Control (CDC): Health care providers test everyone between the ages of 13 and 64 at least once as part of routine

health care. Almost one in five people in the United States who have HIV do not know they are infected (CDC

Testing, 2013). High-risk populations should be tested yearly. No specific HIV consent should be required; HIV

testing should be included in general consent with all other testing. Confidentiality should be maintained though HIPAA laws (Revised Recommendations for HIV Testing, 2006).

Recommendations for practice -- screening

An FDA-approved 4th generation HIV-1/2 immunoassay (IA) should be used as the initial test, to screen for acute HIV-1 infection and for established infections with HIV-1 or HIV-2.

This testing should be followed by “confirmatory Western blot or immunofluorescent assay” (USPSTF, 2013).

Acute HIV infection is considered the time between the detection of HIV RNA and IgG antibodies (Control, 2012). The conventional serum testing is considered the “gold standard” for testing, with extremely reliable sensitivity and specificity (>99.5% for both), and results are available within two days from standard laboratories (USPSTF, 2013).

Limitations: Patients may not return for results Test requires venipuncture by certified laboratory personnel. This makes outreach efforts to identify at-risk infected

populations more difficult. While rapid oral testing can be preferred in some situations, results for early seroconversion can be highly variable, with sensitivity lacking up to 66% of the time for early infections, which suggests that this type of testing may work best when coupled with additional, more definitive testing (Evaluation of a 4th generation rapid HIV test, 2010).

In previous generations of tests, those patients that were antibody-negative would register on those tests as a false negative.

Following determination of reactivity to antibody presence via utilization of 4th generation IA, a second test with a 2nd generation HIV ½ IA should be performed to determine HIV-1 or HIV-2 presence. Incorrect identification of HIV type can result in a delay in accurate results, higher costs and further risk to the patient (Control 2012).

Reliability and Validity of HIV1/2 Screening Tests Enzyme-Linked Immunosorbent Assays (ELISA)/ Enzyme

Immunoassays (EIAs) for detection of HIV Antibody

4th Generation EIAs now able to detect antigen and antibody: Antigen Sandwich Method

0 FDA approved EIAs, 1-4th generation assay

Detection of antibody 3-4 weeks after infection, shortened to 2 weeks if antigen test included for p24 core protein

In a comparison of 36 commercial assays in 1991 before the use of the 4th generation assays, all had a sensitivity of 96% or greater (95% C.I.) and all had a specificity of 96% or greater (95%C.I). (Van Kerckhoven et al., 1991)

Reliability Rapid Tests

4 Rapid tests are approved for use in the U.S.

Dot blot/ Immunoblot easily transported, Tests like Oraquick/Orasure performed on site

Detection of antibody 3-4 weeks after infection

Comparison of Rapid Tests and ELISA yielded an analytical sensitivity greater than ELISA 99.2% and specificity of 99.9%. (Ketema, et al., 2001)

Study of pooled specimens yielded sensitivity of 2 rapid tests 98.88%-100%, specificity 99.45-99.56% concordance with confirmatory EIA/Western blot. (Soroka, et al., 2003)

CDC reports confirm sensitivity and specificity of the Oraquick Advance and Uni-Gold Recombigen tests above 99.0% (95% C.I.)

Positive Predictive Value

ReliabilityImplications for Practice Related to Testing Technology

ELISA/EIA Pooled specimens able to lessen cost of test Standard of care demands follow-up confirmatory test PPV lower in populations with lower incidence and risk assessment could be

necessitated to screen for test

Rapid Tests Point of Care testing, results available in 20-40 minutes May be used in a variety of settings, flexibility in specimen: saliva, plasma,

whole blood, or finger stick Quality control measures/ reagent built in to each singular test Advantageous in Labor and Delivery for women who have had no prenatal

care and antiretroviral therapy may reduce transmission of HIV during delivery to the newborn

Useful in developing countries or alternative settings where laboratory technology cannot facilitate controlled conditions

Disadvantages include subjective interpretation, single test cost, and poor performance in detecting acute infection

Women’s Health Specialists HIV screening test blood draw. HIV ½ antibody, Elisa/reflex WB. Result in 24 hours. Walk-in basis If reactive refers to Shasta Community Health Center’s HIV/AIDS Program Average age 16-26, oldest to request HIV test was 72 year old male Reports to Shasta County Public Health Accepts Family Pact Green Card, Medi-Cal and private insurance. Family Pact pays for those still able to

reproduce Planned Parenthood

Uni-Gold Recombigen Rapid HIV Test, Sensitivity 100%, Specificity 99.7% Whole blood finger stick if reactive orders confirmation HIV ½ antibody, Elisa/reflex WB blood draw Prefer appointments, walk-in accepted If blood lab test reactive refers to Shasta Community Health Center’s HIV/AIDS Program Average age 16-28 Family Pact Green card, Medi-Cal, Private insurance

What is actually done in Shasta County

Shasta Community Health Center Ryan White Early Intervention Services (EIS) Clearview HIV ½ Stat-Pak Sensitivity 99.7% Specificity 99.9% Homeless and incarcerated Free to patients, funded by Federal Grant Ryan White Early Intervention Services

Health Outreach for People Everywhere (HOPE) Mobile Medical Unit Clearview HIV ½ Stat Pak, provided by (EIS) Homeless Free

Shasta County Jail Clearview HIV ½ Stat-Pak Anyone who requests test Performed by EIS nurse weekly Free

Ethical: 1) Confidentiality, 2) Informed Consent, 3) Conflict of Interest 4) Justice

1) Only the person with HIV is able to disclose their status. Healthcare workers can be notified for protection. An obligation to treat people with respect by maintaining confidence.

2) The person that is having the testing done has the right to consent or not consent and will be informed of why it is necessary. Respecting other peoples secrets.

3) Healthcare workers have a duty to do good and avoid harm. Beneficence can be the doctors duty to put the best interest of the patient first. Rights of treatment and the right to refuse treatment.

4) Justice requires that people are treated fairly.

Economics: Higher government spending in healthcare. Ryan White Care Act was passed as a means to help those who are

living with HIV and AIDS and who are unable to cover the cost of their own care. It is the largest federally funded program of its kind in the United States.

Costs to companies through benefit payment and replacement costs.

Ethical, Economical and Legal Issues of HIV Testing

HIPPA-Health Insurance Portability and Accountability Act of 1996 Protect the privacy of patient medical records and other health information. HIPPA has proven to be very effective in

preventing discrimination against people living with HIV/AIDS by preventing others from knowing their HIV status. Fairness to all. Treatment is good, but everyone has to have access to it. ADA-Americans with Disabilities Act of

1990 Legal Resources-AIDS legal Referral Panel. A San Francisco organization that is dedicated to providing free and low-

cost legal assistance and education on any civil matters. Wills, Guardians and Powers of Attorney Assisted Dying Legal Issues in the Workplace Policies on Reporting HIV Test Results-states report the names and demographic information of people diagnosed

with HIV to the federal Centers for Disease Control and Prevention. Repeal HIV Discrimination Act A person engaging in sexual activity without disclosing their HIV status is a felony . Partner notification is important

so that people can become aware of their HIV risks and receive HIV counseling and testing.

Legal

Arduino, R., Baker , M., Fitzpatrick, L., Hare, B., Harrington, R., Turner, O., Turner, O., & Rimland, D. AIDS Info, (2013). Guidelines for the prevention and treatment of. Retrieved from website: http://www.aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf

Centers for Disease Control and Prevention, (2013). HIV in the united states: At a glance. Retrieved from website: http://www.cdc.gov/hiv/statistics/basics/ataglance.html

Centers for Disease Control and Prevention- Testing - HIV Basics - HIV/AIDS. (August, 2013). Retrieved September 28, 2013, from http://www.cdc.gov/hiv/basics/testing.html

Control, D. (2012). Draft Recommendations: Diagnostic Laboratory Testing for HIV Infection in the United States, 4–5. Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy. (January, 2010). Retrieved September 28, 2013, from

http://www.sciencedirect.com.mantis.csuchico.edu/science/article/pii/S1386653212000893 Ketema F, Zeh C, Edelman DC, Saville R, Constantine NT. Assessment of the performance of a rapid, lateral flow assay for the detection of antibodies to HIV. J

Acquir Immune Defic Syndr. 2001 May;27(1):63-70 [PubMed ID: 11404522] Nakagawa, F., May, M., & Phillips, A. (2013). Life expectancy living with HIV: recent estimates and future implications. Current Opinion In Infectious Diseases, 26(1),

17-25. doi:10.1097/QCO.0b013e32835ba6b1 New DHHS treatment guidelines green light earlier HIV treatment: evidence shows benefit of early ART. (2010). AIDS Alert, 25(4), 37-40 Pinkerton, S., Bogart, L., Howerton, D., Snyder, S., Becker, K., & Asch, S. (n.d.). Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/20578906Revised

Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. (September, 2006). Retrieved September 30, 2013, from http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

Soroka SD, Granade TC, Phillips S, Parekh B. The use of simple, rapid tests to detect antibodies to human immunodeficiency virus types 1 and 2 in pooled serum specimens. J Clin Virol. 2003 May;27(1):90-6. PMID: 12727534

U.S. Preventive Services Task Force: Screening for HIV: Final Recommendation Statement. (April, 2013). Retrieved September 28, 2013, from http://www.uspreventiveservicestaskforce.org/uspstf13/hiv/hivfinalrs.htm#summary Van Kerckhoven I, Vercauteren G, Piot P, van der Groen G. Comparative evaluation of 36 commercial assays for detecting antibodies to HIV. Bull World Health Organ. 1991;69(6):753–760.

References