US Pharm. 2013;38(4):8-11.

The scourge of HIV/AIDS continues with little relief in sight. According to the CDC, an estimated 1,148,200 U.S. citizens aged 13 years and older live with HIV infection, and about 18% of those individuals do not know they are infected.¹ Further, the CDC estimates that 1,129,127 people have been diagnosed with HIV/AIDS in the U.S. since the epidemic began, resulting in an estimated 619,400 deaths. HIV incidence (new infections) is about 50,000 annually, a number that has gone neither up nor down in the past several years.^1,2

Epidemiology of HIV

Given the fact that health care resources are limited, the CDC developed a strategy to prioritize prevention efforts by concentrating on groups where HIV is more common.² The goal is to eliminate disparities by lowering the incidence in those at greater risk.

The list of high-risk groups for contracting HIV has not changed appreciably since the initial investigations. Foremost is the large group of gay men, bisexual men, and all other men who have sex with men (MSM), regardless of race or ethnicity. This group experienced a 12% increase in number of new HIV infections from 2008 to 2010 (26,700 and 29,800, respectively).¹ While MSM only constitute 4% of the males in the U.S., they contracted 78% of new HIV infections in males and 63% of all new infections.¹

Heterosexuals and injection drug users continue to be at high risk. Heterosexuals contracted 25% of new HIV infections in 2010, and injection drug users contracted another 8%.¹

Race/ethnicity also plays a critical role in the epidemic. Blacks constitute only 14% of the U.S. population, but experienced 44% of new HIV infections in 2010. If present trends continue to hold, the CDC estimates that 1 in 16 black men and 1 in 32 black women will contract HIV. Hispanics/Latinos are also at increased risk. They make up 16% of the U.S. population, but experienced 21% of new infections in 2010. Latinos are 2.9 times more likely to experience new HIV infection than white males, and Latinas have a risk rate 4.2 times higher than that of white females.¹

The Role of STD Testing in Preventing HIV

The CDC published an informational brochure emphasizing the importance of detecting the presence of other sexually transmitted diseases (STDs).³ It explained that people with an existing STD are 2 to 5 times more prone to acquire and/or disseminate HIV infection through sexual contact than those without an STD. This is partly due to the fact that certain STDs (e.g., syphilis, herpes, chancroid) cause genital ulcers. These breaks in the skin or genitourinary mucosa create a portal of entry for HIV. Patients with coexisting HIV and other STDs are also more likely to shed HIV in their genital secretions. For instance, men with gonorrhea and HIV have a 10-fold increase in HIV in their semen compared to a group without gonorrhea. The CDC stressed that detecting and treating an existing STD is vital in halting HIV.³

When Should Patients Be Tested for HIV?

Editor's Note (4/30/13): The U.S. Preventive Services Task Force (USPSTF) recommends that all adolescents and adults aged 15 to 65 years be screened for HIV. Pregnant women and anyone younger or older at increased risk should also be screened.

The FDA attempted to clarify the issue of when to test for HIV.⁴ The agency explained that every-one who engages in behavior that puts him or her at risk for HIV should be tested on a regular basis. If his or her partner engages in such behavior, it is also mandatory to obtain regular testing. The agency then explained the concept of the “window period.” This is the time frame between contracting HIV infection and producing sufficient antibody to be detectable. Although HIV screening tests suggest that persons are HIV negative during this window, they are infected nevertheless and can disseminate HIV to sexual partners. About 97% of those infected will develop detectable antibody levels in the first 3 months after infection (the window period), although some patients may take as long as 6 months.⁴

Choosing an HIV Detection Method

When patients ask about being tested, pharmacists can question them about the factors that differentiate current testing methods. For some patients, anonymity is the chief concern. Others wish to obtain the fastest result. Patients may prefer a test that does not require a blood sample.

Professional HIV Tests

If the patient chooses to visit a physician to undergo professional HIV testing, there is no anonymity, as a name must be divulged before the office will even make an appointment. While HIPAA rules always apply, the physician will know the patient’s status, and patients may fear that other personnel in that practice who know them and/or their partner(s) will have access to their charts.

Patients may know that positive results will be reported to their state health department, just as other STD results are reported.⁵ Patients may also be worried that if they request a professional test, their insurance company will be notified. The CDC explained that, generally, testing laboratories are not required to provide results to insurance companies, and can only reveal the results to the “authorized person” (i.e., the patient or physician who ordered the test and is responsible for using the results).⁵

A further issue with professional HIV testing is that immediate results are not possible. If patients want to discover their status so they can make a decision about an upcoming sexual encounter, the results may not be available in time for them to make the necessary decisions and take the appropriate precautions.

Home Access Test Kits

Two products are sold under the Home Access HIV-1 Test System trade name (standard and express), differing in cost and the rapidity with which the patient may obtain results. The FDA reported that when HIV is present, the test will provide a positive result in more than 99.9% of cases.⁶ Similarly, when HIV is not present, the test will yield a negative result over 99.9% of the time.

The use steps for both tests are virtually identical.^7,8 The patient (hereafter referred to as “he” for ease of reading) first locates the Blood Specimen Collection (BSC) Card and tears away its top sheet, which contains a confidential personal Home Access Code Number. He reads the informed consent section of the enclosed booklet and calls the toll-free number included in the kit (1-800-400-8988) to register his confidential 11-digit code number. Making the call indicates that he has agreed to the informed consent section of the booklet. The registration phone call can be made anytime, 24 hours a day, 7 days a week. Counselors are available to speak to patients and answer questions, except for on holidays.

To collect the Blood Spot Specimen, the patient places the specimen collection kit on a clean, dry surface in a location where he will be uninterrupted for 20 minutes or so. He washes and dries his hands with soap and warm (not hot) water. He next uncovers a printed circle on the BSC Card where the blood specimen will be placed. The middle or ring fingers are preferred sampling sites. (At one time, the manufacturer advised against using the little finger since sufficient blood may not be available.) He chooses a puncture site on the soft pad of the fingertip. Callused areas should be avoided to ensure that an adequate amount of blood can be collected.^7,8

The patient cleans the puncture site with the alcohol pad included in the kit, then hangs that hand by his side for 30 seconds and shakes it back and forth vigorously for a few seconds to stimulate blood flow to the fingers. The hand is then positioned on a table or countertop with the palm up to help avoid inadvertent flinching or pulling away. The lancet included in the kit is held between the first and second fingers of the other hand. The patient presses the tip of the lancet against the target finger, applying steady pressure to indent the skin in the selected location. The thumb is used to depress the lancet trigger, using steady pressure. After the skin is pierced, the patient turns the hand over to allow large drops of blood to collect at the puncture site. Blood flow can be increased by using the thumb and first finger of the opposite hand to gently apply pressure to the puncture site.^7,8

The patient then touches a large drop of blood to the circle printed on the BSC Card. Additional drops may be placed around the edges of the primary drop to completely fill the circle. He then pulls back a protective cover to allow him to examine the back of the card, to ensure that blood has completely soaked through and filled the back of the circle. If it has not, he places more blood on the front of the card. He applies an adhesive bandage from the kit over the puncture site and inserts the used lancet in the lancet disposal container included in the kit.^7,8

To finish the process, the patient writes the Home Access Code Number and the date the specimen was collected on the BSC Card. The blood spot must air dry for 30 minutes before proceeding further. He then places the BSC Card inside the Specimen Return Pouch included in the kit, sealing the pouch tightly and placing it in the U.S. Mail envelope included in the kit for the standard Home Access HIV-1 Test System. If the patient purchased the Home Access Express HIV-1 Test System, the sealed sample is placed in the prepaid FedEx envelope provided for overnight shipping.^7,8

The patient can call for results after 7 business days with the standard test or 1 business day (excluding weekends and holidays) with the more expensive express test. The company has not investigated use of the product in patients <18 years of age.^7,8

OraQuick In-Home HIV Test

Compared to the Home Access line, the OraQuick In-Home HIV Test has several distinct advantages.^9,10 It allows the user to determine his own status, without any other individual learning the results. Unlike Home Access, OraQuick is saliva-based. It gives more rapid results than any other test. OraQuick is for those aged 17 years and above. The patient does not eat, drink, or use oral care products for 30 minutes prior to testing. Dentures and oral appliances are removed. The patient then swabs the test stick once between the teeth and upper and lower gums. The stick is inserted into a test tube (supplied with the kit) for 20 to 40 minutes and is read at home. Positive results should be confirmed by another test.

The FDA states that OraQuick detects HIV 92% of the time when infection is present, and that it gives negative results 99.98% of the time when HIV is not present.^9,10

PATIENT INFORMATION

Who Is at Greatest Risk of HIV/AIDS?

Unprotected sexual contact (oral, vaginal, rectal) with a partner of either gender is risky. The largest group of people affected by HIV continues to be gay and bisexual men, as well as any other men who have sex with men. At least 63% of all new HIV infections occur in this group, with the greatest number of new infections being in young blacks/African Americans aged 13 to 24 years. Approximately 25% of new HIV infections occur in heterosexuals, and injection drug usage continues to be a risk factor. Blacks/African Americans and Hispanics/Latinos are disproportionately affected. Patients in these risk groups may wish to test for the presence of HIV/AIDS.

The Value of HIV Home Testing

All high-risk patients should check for the presence of HIV. Remaining unsure about your HIV infection status is of no benefit. On the other hand, discovering that you are HIV positive allows you to visit your physician to begin therapy earlier. Furthermore, if you discover you are HIV positive, you can take the steps necessary to protect your sexual partner(s) from contracting HIV too.

At-Home HIV Tests

At the present time, you have two options for detecting HIV at home. The products mentioned here are the only home test kits proven effective at detecting HIV. You may see ads for other products, especially on unscrupulous Web sites, but do not be fooled by them. If you would like to find out whether a particular test is approved by the FDA, search the agency’s Web site (www.fda.gov).

Home Access Products: Two related products are available under that name: Home Access HIV-1 Test System and Home Access Express HIV-1 Test System. With both products, you are required to send a sample of your blood to the company. The tests differ only in how rapidly the results are available. The first promises results in 7 business days (excluding Sundays and holidays) after your sample is shipped to them, while the express version’s results are available the same day the lab receives your sample (excluding weekends and holidays). In both cases, results can be obtained via a phone call, after you have provided the confidential code number found in the package. The Home Access standard test is available online from the manufacturer for $44, while the express kit costs $59.95.

OraQuick: OraQuick is a recently introduced in-home HIV test that differs markedly from the older Home Access products. It uses an oral fluid sample rather than blood to detect HIV. Moreover, no mailing is required, as the test gives results in your home within 20 to 40 minutes. It costs about $39.99 and is available online and at retail pharmacies. Counselors are available 24 hours a day to answer any questions at the OraQuick Support Center (1-866-436-6527).

Further Information

You should always Consult Your Pharmacist if you have questions about OTC products such as at-home HIV tests. Additional information can be obtained by consulting the manufacturers’ Web sites, www.homeaccess.com and www.oraquick.com.

Remember, if you have questions, Consult Your Pharmacist.

REFERENCES

1. HIV in the United States: at a glance. CDC. www.cdc.gov/hiv/resources/factsheets/us.htm. Accessed February 22, 2013.
2. CDC fact sheet: estimates of new HIV infections in the United States, 2006-2009. CDC. www.cdc.gov/nchhstp/newsroom/docs/HIV-Infections-2006-2009.pdf. Accessed February 22, 2013.
3. The role of STD detection and treatment in HIV prevention—CDC fact sheet. CDC. www.cdc.gov/std/hiv/STDFact-STD-HIV.htm. Accessed February 22, 2013.
4. Testing for HIV. FDA. www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/HIVHomeTestKits/ucm126460.htm. Accessed February 22, 2013.
5. Questions and answers for the general public. CDC. www.cdc.gov/hiv/topics/testing/resources/qa/qa_general-public.htm. Accessed February 22, 2013.
6. Information regarding the Home Access HIV-1 Test System. FDA. www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311903.htm. Accessed February 22, 2013.
7. HIV-1 Test: how it works. Home Access Health Corporation. www.homeaccess.com/HIV_How_Works.asp. Accessed February 22, 2013.
8. Express HIV-1 Test: how it works. Home Access Health Corporation. www.homeaccess.com/ExpressHIV_How_Works.asp. Accessed February 22, 2013.
9. Information regarding the OraQuick In-Home HIV Test. FDA. www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311895.htm. Accessed February 22, 2013.
10. OraQuick. OraSure Technologies, Inc. www.oraquick.com. Accessed February 22, 2013.
11. Herbal treatments and remedies. Food and Agriculture Organization of the United Nations. www.fao.org/docrep/005/Y4168E/y4168e10.htm. Accessed February 22, 2013.

To comment on this article, contact rdavidson@uspharmacist.com.