Showing posts with label HIV Screening. Show all posts
Showing posts with label HIV Screening. Show all posts

December 1, 2013

Join the Fight Against HIV/AIDS by Getting Tested

Quinn Tivey Photographer

Posted: 12/01/2013 11:51 am

At the 1992 Freddie Mercury Tribute Concert, my grandmother, Elizabeth Taylor, gave some simple and on-point sexual advice: "Straight sex, gay sex, bisexual sex: use a condom -- whoever you are."

It might seem a bit unusual to hear your grandma reminding you (and a packed stadium) that if you're getting laid, use a condom. But she was always blunt -- and someone who spoke straight from her heart.

Since her death, I've been striving to continue on the path that my grandmother helped to establish in the fight against HIV/AIDS. Last year I helped to start a Los Angeles branch of genCURE, a youth-oriented division of amfAR (which she helped to form in 1985), and over the last few months, I have been working closely with the support-based Elizabeth Taylor AIDS Foundation (ETAF) that she started in 1991.

At 27 years old, I've noticed that many of my friends don't seem to regard HIV/AIDS as a major concern in their lives. This is bewildering considering that here in the U.S. the CDC counts 20-24 year olds as the largest group of new infections and young adults and teens between 13 and 29 as comprising over 35 percent of new infections across all age groups. Of course, my age group is not uniquely at risk of infection. Persons of every age, background, sexuality, everywhere in the world, can be at risk. There are approximately 35 million people living with HIV around the world (WHO), with over a million here in the U.S., a fifth of whom do not realize they are positive (aids.gov).

So now, 25 years after the first World AIDS Day in 1988, I'm writing to reiterate the same fundamental call to awareness and action that World AIDS Day was founded upon and to which my grandmother was dedicated. I'm asking my friends and peers, young and old, gay and straight -- anyone who is reading this -- to engage in the individual responsibilities that we all share in the global fight against HIV/AIDS.

In 1986 the US Surgeon General C Everett Koop released a report on AIDS in which he recommended condom use, testing to know one's HIV status and avoiding sharing needles as individual ways of stopping transmission of the virus. These basic principles aren't new but they are worth repeating year after year and generation after generation.

Get tested if you could have been exposed to anything that puts you at risk of HIV infection. The importance of getting tested is eloquently summarized in this brief video produced by Portland, Oregon-based Cascade AIDS Project, which is funded in part by ETAF. As the video clearly states: "one in five people who have HIV don't know they have it, but when they do know, they are 70 percent less likely to pass HIV to their partners, and if they take medication, use protection, and stay in care, then transmission rates can drop by up to 96 percent."

To expand upon that: If you are in an exclusive and trusting relationship and don't want to use protection, get tested together. I have friends who entered into exclusive relationships and began having unprotected sex because both parties thought (or claimed) themselves to be negative. They later learned, too late, that one of the partners had actually been positive and had transmitted the virus.

At the Freddie Mercury tribute concert I mentioned earlier, my grandma went on to give some more good advice: "If you share drugs, don't share a needle." She stood behind that advice by personally funding 59 syringe exchange programs since 1992. According to the Lower East Side Harm Reduction Center in Manhattan, to which ETAF has been providing funding since 1999, the transmission rate among injection drug users in New York State has plummeted from over 50 percent in 1992 to about 5 percent as of 2008. That exceptional drop in transmission speaks volumes to the importance of using clean syringes if you are using injection drugs.

ETAF and amfAR have helped to save countless lives around the world. Such organizations are imperative in our communal response to HIV/AIDS. Our individual actions are too.

If you engage in sexual or drug-related activities, it doesn't matter whether you identify them as being "high risk" or "low risk," because either way, you can be at risk. So, I'm writing now to simply say: please be careful. Demonstrate responsibility to yourself and those with whom you might share yourself. It is through such individual responsibility that we can each participate in the international fight against HIV/AIDS, and work towards ending the pandemic one step at a time.

Source

November 27, 2013

HIV Screening for New Inmates Has Low Yield

Published: Nov 27, 2013

By Michael Smith, North American Correspondent, MedPage Today

Screening for HIV among people entering a prison system might not pick up a lot of new cases, researchers reported.

In an 11-month period, HIV testing of new inmates in North Carolina found that 1.45% of them had HIV, according to David Wohl, MD, and colleagues at the University of North Carolina in Chapel Hill, N.C.

But only a handful of those cases -- less than 0.1% -- were previously undiagnosed, Wohl and colleagues reported in the Nov. 27 issue of the Journal of the American Medical Association.

The finding suggests that undiagnosed HIV might be relatively rare among prisoners, contrary to the common perception that prisons are hotbeds of unknown infections, Wohl argued.

"The whole concept is let's screen these people because we'll find undetected, undiagnosed HIV; that there's going to be a wellspring of undetected HIV," he told MedPage Today. "We found that was not the case at all in our state."

In North Carolina, an HIV test on prison entry was voluntary during the study period in 2008-2009, but a syphilis test was mandatory, Wohl and colleagues noted.

HIV testing is now mandatory in the state's prisons, Wohl said.

The researchers used excess blood from the syphilis tests for an HIV assay, but before the HIV results were de-identified, they were compared with the North Carolina Department of Health and Human Services HIV testing database.

Of the 23,373 people who entered the system from June 2008 through April 2009, 22,134 (94.7%) had sufficient excess blood to allow HIV testing.

All told, 320 inmates (1.45%) were HIV-positive, but 300 were already known to be infected with HIV.

In other words, just 20 of 22,134 new inmates were HIV-positive -- 0.09% -- and not previously known to be, Wohl and colleagues found.

Among the 1,239 new inmates without enough excess blood for HIV testing, 1,066 had a voluntary test in prison and 36 (4.8%) were HIV-positive. All 36 were previously known by the state health department to be infected, Wohl and colleagues reported.

"I was astounded that 94% of people coming into prison who have HIV were already known to have HIV," Wohl said.

The study suggests that aggressive testing in prisons is unlikely to reap a good yield of new HIV cases, Wohl said.

"If you want to go find a place where there's a lot of people undiagnosed with HIV, the prison population in North Carolina is not it," he said.

The prevalence of HIV among the new inmates -- about 1.43% among all of those who were tested -- is about the same as the CDC estimate of 1.4% among the national prison population, both state and federal.

Other researchers have found relatively high rates of HIV among people held in local jails, usually for short periods of time, before they are released or sent on to prison.

But it's "likely that the prison population is fairly representative of what we're talking about in jails," Wohl said, although the jail population is larger.

Wohl and colleagues cautioned that it's possible that a known HIV diagnosis might have resulted from screening during a previous prison term, although almost half the people with a known infection had not previously been incarcerated.

They also noted that North Carolina has the eighth highest HIV prevalence in the U.S. and the findings of the study might not apply to other states.

The study had support from the National Institute of Mental Health and the University of North Carolina Center for AIDS Research.

Wohl reported financial links with Janssen, Gilead, GlaxoSmithKline, and ViiV.

Primary source: Journal of the American Medical Asssociation
Source reference: Wohl DA, et al "Detection of undiagnosed HIV among state prison entrants"JAMA 2013; 310(20): 2198-2199.

Source

August 17, 2013

Rapid HIV Self-testing: Long in Coming but Opportunities Beckon

AIDS

Julie E. Myers, Wafaa M. El-Sadr, Allison Zerbe, Bernard M. Branson

AIDS. 2013;27(11):1687-1695.

Abstract and Introduction

Abstract

The recent approval by the United States Food and Drug Administration of a rapid HIV self-test marks a significant milestone in the evolution of HIV testing approaches. With nearly one in five people living with HIV in the United States still undiagnosed and an even higher proportion unaware of their infection globally, this decision reflects a new willingness to offer diverse options to get tested for HIV. Rapid self-testing offers several distinct opportunities to improve testing among those with undiagnosed HIV: to encourage testing among those who might not otherwise be tested, to increase the frequency of testing among persons at highest risk for new infection, and to facilitate mutual HIV testing with sex partners. To date, the path to regulatory approval has been long but instructive. The studies and clinical trials required for regulatory approval in the United States provide insight into the performance and potential implications of HIV self-tests as they become available for sale directly to consumers. Although some persistent reservations about self-testing for HIV remain, including the 'window period' of the current test kit, its cost, and its effectiveness for facilitating entry to medical care, others have been dispelled. Self-testing in resource-constrained settings is also promising, including self-testing of health professionals. At present, although the impact has yet to be determined, availability of this new option might offer potential opportunities to improve HIV diagnosis and facilitate both treatment and prevention.

Introduction

Nearly one in five people living with HIV in the United States are unaware they are infected.[1] Globally, approximately 60% of those with HIV are unaware.[2] Persons who are unaware of their infection account for almost half of all sexual transmissions in the United States[3] and contribute disproportionately to the continued spread of HIV. Thus, HIV testing remains essential to HIV prevention efforts in the United States[4,5] and worldwide.[6] Prompt identification of HIV infection offers many benefits to both the individual and community. In the United States, antiretroviral therapy (ART), with the goal of viral suppression, is now recommended for all persons with HIV infection;[7] in resource-constrained settings, WHO has recommended ART for all persons with a CD4+ cell count of less than 350 cells/μl and for the HIV-positive partner in serodiscordant couples.[8,9] Durable viral suppression improves immune function and quality of life, decreases morbidity, and improves survival.[7] HIV-positive persons in the United States appear to reduce high-risk sexual behavior after they become aware of their diagnosis, at least temporarily.[10] Mathematical models provide support that early ART initiation would decrease HIV transmission[11–15] and findings from the HIV Prevention Trials Network 052 study,[16] which documented this benefit, further stimulated interest in scaling up HIV testing and using of ART for prevention. Thus, additional effective methods are needed to increase HIV testing.

Self-testing, with its convenience, privacy, and anonymity, might present a promising option. With approximately 208 000 persons with undiagnosed HIV infection in the United States alone, 50 000 annual new infections in the United States[17] and 2.7 million globally,[2] it is essential to promptly identify HIV-infected persons.

Rapid Self-tests: Possible Roles

Rapid self-testing offers several potential opportunities. First, it might be used by persons in high-prevalence communities who have eluded previous prevention and testing efforts.[18] In the United States, the proportion of persons with undiagnosed infection is highest among racial and ethnic minorities and young people; an estimated 68% of all persons with undiagnosed HIV are black or Hispanic[1] and 60% of persons aged 13–24 years with HIV are unaware of their infection.[1] These same populations, that is, racial and ethnic minorities and young people, expressed high levels of interest in using rapid HIV self-tests in a 2006 population-based telephone survey in New York City (NYC).[19] MSM, a population at high risk in the United States,[5] were the subject of an online survey in six cities.[20] Among those who had never been tested for HIV, 86% of those likely to get a test in the next year expressed strong intentions to use a rapid self-test, if available. A majority (87%) of MSM surveyed online in France were interested in self-tests, if available; interested men were more likely to have never tested or to have not tested in the past year, and to live their sex lives with men 'in absolute secrecy'.[21] The small proportion of the MSM (3.5%) in the study who had already accessed unapproved tests online had similar characteristics.[22]

A second prospect for rapid HIV self-tests might be to facilitate more frequent testing among persons at highest risk for HIV. Centers for Disease Control and Prevention (CDC) guidelines recommend HIV testing at least annually for individuals at high risk of HIV.[23,24] More frequent testing is necessary for populations with high incidence, and the convenience of self-testing could facilitate this. In the 2008 US National HIV Behavioral Surveillance (NHBS), HIV prevalence was 19% among MSM; nearly half (44%) were unaware of their infection.[25] Although 61% of the MSM recruited from venues in 21 metropolitan areas reported testing for HIV within the preceding 12 months, 7% of these had a new, positive HIV test.[25] Fully 45% of the MSM who were unaware of their infection had been tested within the preceding 12 months.[25] Among MSM in a study of HIV self-testing at a Seattle sexually transmitted infection (STI) clinic, 84% said they would test more frequently with a rapid self-test – depending on its cost.[26]

A third potential for rapid self-test is that such tests might facilitate mutual HIV testing with sex partners or even 'point-of-sex' testing.[27] During in-depth interviews with HIV-negative MSM in NYC who never or rarely used condoms, 80% indicated that they would likely use an over-the-counter rapid HIV test to test sex partners (some with new partners and others indicated with established partners).[28] In a follow-up study, 27 participants who received rapid test kits used them before planned intercourse with approximately 100 prospective sex partners; some of the kits were also used to test acquaintances.[29] No sexual intercourse took place after a detected positive test, and most participants said that having and using rapid HIV test kits shifted their perceptions of risk and led to changes in behavior.[29]

Availability of rapid HIV self-tests offers a fourth opportunity. Such tests could be used to help detect 'window period' infections by repeat testing several weeks after a negative HIV test in persons with very recent potential exposure to HIV. Rapid tests in wide use in the United States and globally detect only IgG antibodies and have an estimated window period of 25–35 days.[30,31] Studies at HIV testing programs in STI clinics demonstrated that, among patients with undiagnosed HIV, 5% of those in Malawi, 9% of those in NYC, and 20% of MSM in Seattle had detectable HIV RNA despite a negative rapid antibody test.[32–34]

Self-testing for HIV: Old Concept, New Opportunities

The concept of self-testing for HIV is not new. Home collection kits for HIV testing were first proposed in 1986. However, professional organizations, public health agencies, and gay activists expressed concern that the tests might be inaccurate or increase the risk of suicide.[35] In addition, the US Food and Drug Administration (FDA) expressed concern about the safety and efficacy of obtaining HIV test results without professional supervision. Nonetheless, in 1996, the FDA approved two home sample collection kits for HIV as technology advanced and desire for greater personal autonomy for healthcare decisions grew.[35] Both involved self-collection of dried blood spot specimens that are mailed to a laboratory for testing with access to test results by telephone.[35] Postmarketing data demonstrated that the kits were used by persons at risk and by those with no other access to HIV testing; more than half (including half with positive tests) had not been tested previously.[36] However, home sample collection kits were not widely adopted by persons at high risk for HIV infection.[37]

Prospects for true self-testing for HIV changed considerably with FDA's approval, in 2002, of rapid HIV tests eligible for waiver under the Clinical Laboratory Improvement Amendments (CLIA)[38] (Table 1), and their subsequent widespread use (even though their sale was limited to agents of a clinical laboratory).[39] Rapid HIV tests significantly increase the number of people who learn their test results[40] and are preferred by high-risk persons[41] and those not previously tested.[42]

Table 1.  Five United States Food and Drug Administration-approved, Clinical Laboratory Improvement Amendments-waived rapid HIV antibody screening tests.

Test type FDA approval received Specimen typea Manufacturer Approved for HIV-2 detection?
OraQuick ADVANCE Rapid HIV-1/2 antibody test Nov 2002 Oral fluid

Whole blood (fingerstick or venipuncture)
OraSure Technologies, Inc. www.orasure.com/productsinfectious/products-infectiousoraquick.asp (Bethlehem, Pennsylvania) Yes
Uni-Gold Recombigen HIV Dec 2003 Whole blood (fingerstick or venipuncture) Trinity Biotech; www.unigoldhiv.com (Jamestown, New York) No
Clearview HIV 1/2 STAT-PAK

Clearview COMPLETE HIV 1/2
May 2006 Whole blood (fingerstick or venipuncture) Alere, Inc. (formerly known as Inverness Medical Professional Diagnostics); www.alere.com/EN_US/index.jsp (Waltham, Massachusetts) Yes
INSTI HIV-1 antibody test Nov 2010 Whole blood (fingerstick) bioLytical Laboratories, Inc.; www.biolyticalus.com (Richmond, British Columbia, Canada) No

FDA, United States Food and Drug Administration.

aSpecimens types for which the tests are Clinical Laboratory Improvement Amendments (CLIA)-waived. The tests are categorized as moderate complexity under CLIA if used with serum or plasma.

Experiences With HIV Self-testing

Three US-based studies conducted with the oral fluid HIV test use demonstrated self-testing was feasible and persons were willing to perform the test. In an emergency department study in a Baltimore hospital, rapid HIV self-test results were 99.6% concordant with results of tests performed by healthcare professionals; 97% of participants agreed that oral fluid samples were 'not at all hard to collect'.[43] In a randomized study of unobserved self-test use among MSM in Seattle, 68 men received a kit, 45 of whom obtained 100 additional kits for subsequent testing. Among 43 men who completed 69 surveys about the kits, it was noted to be 'very easy to use' on 66 (96%) surveys and 'somewhat easy to use' on the other three.[26] Among 42 MSM in a self-testing study in NYC, most participants performed the test without mistake while being observed.[28] International studies found similar results. In Malawi, 260 (92%) of 283 study participants elected an oral fluid self-test after a demonstration.[44] Accuracy was 99.2% (two of 48 participants with positive finger-stick blood rapid tests obtained negative oral fluid self-test results). Although 98.5% of participants agreed that the test was 'not at all hard to do,' 10% made minor procedural errors, and 10% required extra help. A study of oral fluid self-testing in Singapore had similar findings:[45] 977 (99.1%) obtained correct results, and more than 80% said they would purchase a self-test.

The Path to Regulatory Approval

In some countries, rapid HIV tests have been available over-the-counter for several years (e.g., in Hong Kong and Macao since 2005[46] and in South Africa since 2007[47]). In other countries, including the United Kingdom and Australia, sale of HIV tests to the public is prohibited,[48,49] although HIV self-tests of uncertain accuracy are available directly via the internet.[50]

In 2005, after review and public testimony, an FDA advisory committee concluded that self-testing offered potential for public health benefit and later established criteria to allow FDA approval.[51] These included a minimum threshold for accuracy, acceptable performance in a 'real-world' context, and validation of instructional materials demonstrating that users understood the accuracy and limitations of the test (including the 'window period'), and correct interpretation.[52]

In 2012, the manufacturer of the oral fluid HIV self-test, OraSure Technologies (Bethlehem, Pennsylvania) submitted data to the FDA on 5800 participants recruited for unobserved self-testing[53] and presented these to the FDA advisory committee.[54] Label comprehension exceeded 80% on all aspects of performing the test and interpreting the results.[55] Of 5662 individuals who received test kits (Fig. 1), 4562 (82%) were from high-prevalence populations (18% MSM and 82% high-risk heterosexuals). Only 56 (1.11%) users were unable to obtain a result ('test system failures'); 88 self-test results were true-positive, eight false-negative, 4902 true-negative, and one false-positive. HIV prevalence was 2.12%, sensitivity of the self-test 91.67% [95% confidence interval (CI): 84.24–96.33%] and specificity 99.98% (95% CI: 99.89–100.0%).[55]

 808032-fig1

Figure 1.

Disposition of participants in analytic populations of OraSure Technologies phase III clinical trial data submitted to the United States Food and Drug Administration.55 *Data were excluded from 107 individuals who did not complete the study and from 500 individuals from one of the clinical trial sites due to the need for further validation of the data from that site.

Although the test's sensitivity did not meet the recommended minimum requirement, FDA constructed a Monte Carlo model to evaluate the test's potential public health risks and benefits. The model predicted, based on certain assumptions and the results of the clinical trial, that 2.8 million persons with a seropositivity of 1.6% would use the self-test during the first year, yielding 45 000 true-positive and 3800 false-negative test results.[56] Based on the assumption that eight to 10 transmissions would be averted for every 100 persons who learned they were HIV-positive,[3] the model predicted that the self-test might avert more than 4000 new transmissions of HIV during the first year. False-negatives due to the test's sensitivity had implications for individual health, but sensitivity had little effect on the number of net transmissions averted in the model: 4100 at 84% sensitivity; 4600 at 96%. Based on this information, the FDA approved the oral self-test (OraQuick In-Home HIV Test) on 3 July 2012. However, the predicted HIV seropositivity rate of 1.6% might be an overestimate. In the clinical trial, the low prevalence population had a seropositivity of only 0.09%; a population with such a prevalence might be expected to be more representative of kit users.[57]

Concerns About Self-testing: Some Dispelled, Some Remain

Several reservations have been expressed regarding self-testing including concerns about correct interpretation, emotional consequences of a positive result, and theoretical misuse; the FDA-approved test's suboptimal sensitivity and window period of up to 3 months; cost; its effectiveness for facilitating entry to care; and the possibility of 'risk compensation' (that frequent testing or testing before sexual encounters might lead to increased risk behavior).

Lack of counseling and supervision is inherent to self-testing, and mental distress or even suicide after a positive test result is possible.[58,59] However, home sample collection for HIV has proceeded for more than a decade without documentation of adverse consequences,[36,59] and concerns about suicide have not been substantiated.[35,60] Evidence suggestive of increases in suicide comes from older studies prior to availability of effective ART.[61,62] A large study of military recruits did not find a statistically significant increase in the risk of suicide in the months immediately following a positive HIV test.[63] The availability of effective ART has also changed perception of the disease. In fact, some at-risk individuals have reported reduced anxiety[64] or feeling 'calm'[55] upon learning their results.

Concern also persists about the self-test's sensitivity compared with professional-use tests on blood specimens and the possibility that unsupervised self-testing might lead to false reassurance during the acute HIV infection 'window period'.[65–67] These concerns might be especially relevant for the same high-risk populations who expressed specific interest in self-testing. In the study of MSM at the Seattle STI clinic, 16 (8%) of 192 HIV-infected patients had a negative OraQuick rapid test but positive enzyme immunoassay, and an additional 23 (12%) had detectable HIV RNA but no detectable antibody.[34] However, this limitation is applicable to all rapid HIV tests whether conducted by professionals or via self-test, and highlights the importance of frequent retesting in high-risk individuals. Despite the window period, screening prospective sex partners before sex with a rapid HIV test might help reduce HIV transmission.[29,68] One model of transmission among MSM who never used condoms determined that rapid HIV self-testing with unprotected intercourse after a negative result led to a lower probability of HIV infection. However, this benefit was lost if condoms were used in at least one in four sexual encounters.[68]

The price for the self-test kit might affect its potential public health benefits if its adoption is limited only to those who can afford it, rather than those who need it.[18,69] The current retail price of the FDA-approved test in the United States is $39.99. In the report of the 1998–1999 HIV Testing Survey, among the 939 participants who had heard of home collection kits but had not used them, kit cost was the third most common concern (34%) after concerns about accuracy (56%) and lack of in-person counseling (47%).[37] Among heterosexuals in urban areas of the United States, HIV prevalence rates are inversely related to socioeconomic status,[70] and HIV diagnosis rates among all adults and adolescents are higher in communities with a lower socioeconomic composition.[71] Thus, the populations in greatest need of an HIV test might be the least able to pay for it.[69] In NYC, among persons who considered self-testing acceptable, approximately half presented some financial barriers to its purchase.[19] MSM in the Seattle study were also sensitive to price: only 17% would pay $40 or more for a kit.[26] In Spain, 17.9% would pay $38 or more,[72] but in Singapore, only 27.9% of clinic attendees were willing to pay up to $15.[45]

A major concern about the HIV self-test is whether some persons might fail to seek confirmatory testing or medical care after a positive test result. With the home collection kit, 65% of HIV-positive users accepted referrals for medical care, and 23% already had a source of care.[36] In the clinical trial of the self-test, 88% of those testing positive reported they would 'definitely' follow-up with a doctor or clinic; another 8% were 'highly likely' to do so.[55] These results are reassuring, but in the clinical trial, follow-up contact was required, and, thus, responses were not necessarily representative of eventual users. In the Seattle self-test study, one sex partner of a study participant tested positive with a kit obtained from the participant, assumed that the test result was definitive, and did not seek timely confirmatory testing or follow-up care.[73]

Finally, it is not known whether persons who use self-tests might adopt riskier behaviors (i.e. risk compensation) after receiving 'good news' (a negative self-test result). Although risk compensation has not been noted in recent large trials with frequent HIV testing in conjunction with preexposure prophylaxis[31] and male circumcision studies,[74] these trials also included intensive risk-reduction counseling. In contrast, one observational study suggested that increased risk behavior might occur after nonoccupational postexposure prophylaxis.[75] Further, in a vaccine preparedness study that included quarterly HIV testing and counseling, more than half of MSM who subsequently seroconverted reported unprotected anal intercourse after study visits at which they tested negative.[76] This decreased substantially after they received their HIV-positive test result. Definitive answers might await an ongoing clinical trial randomizing MSM to a rapid self-test or a clinic-based test to determine the effects of self-tests on the frequency of testing and risk behaviors.[77]

Strategies for Use of HIV Self-tests

The optimal self-testing paradigm has yet to be established, but a number of alternatives might be feasible. Distributing HIV self-tests through internet solicitations might help reach and increase testing frequency among persons at high risk of HIV acquisition, such as MSM who seek both sexual partners and health information online. Persons visiting social networking sites and urban sexual health clinics are willing to receive HIV testing materials through the mail,[78,79] and French MSM participating in an online survey confirmed their willingness to obtain HIV self-tests online.[21] Alternatively, persons with ongoing HIV risks who seek testing could be invited to distribute kits to their social and sexual networks. Use of social networks to recruit persons for testing has proven successful for identifying a high percentage of persons with undiagnosed HIV.[80]

Self-testing in Resource-Constrained Settings

Although much of the research and discussion about self-testing has been focused in the United States and Europe, such tests also hold promise for resource-constrained countries. Nearly all of 257 heterosexual participants in the community-based study of self-testing in Malawi expressed willingness to test themselves in the future, and all would recommend self-testing to friends and family.[44] However, special challenges in this context include the inability to offer counseling when access to telephones or internet is limited, and the difficulty in obtaining HIV care and treatment for those who test positive. Obstacles to procuring test kits, either due to cost or supply chain logistics, might be another barrier.[81] The lack of regulation to ensure quality of self-testing products poses another challenge.[58,59] However, support for a self-testing paradigm is already mounting,[2] especially as a strategy to increase rates of HIV testing among healthcare workers in Africa,[58] and Kenya's National Guidelines for HIV testing and counseling now include self-testing as a possible option.[82]

Looking Ahead

As the HIV epidemic continues into its fourth decade, rapid HIV self-tests might offer a new tool to increase the number of persons with HIV who become aware of their infection, particularly if the tests are affordable or if test kits can be subsidized for persons at high risk to expand testing and to expedite earlier diagnosis, two key elements of strategies for control of HIV globally.

Yet many questions remain unanswered. Who will ultimately purchase and use the test? Will persons at risk substitute the less sensitive self-test for professional testing, with its better sensitivity? Will those at high risk who have been unwilling to test for HIV use self-tests ([18,57,69])? Will cost of the test limit its adoption among those who could benefit the most? What will be the rate and public health impact of false-negative results in various populations? Will persons with a positive self-test seek follow-up testing and ultimately access medical care?

Finally, the approval of the first self-test kit by the FDA will likely stimulate development of other, potentially better self-test kits. Rapid tests with shorter window periods (e.g. fourth-generation antigen-antibody combination assays) are already available outside the United States,[83] and may, in the future, represent a viable over-the-counter option, based on a recent user feasibility study.[72] Regardless, it is important that policymakers, public health leaders, clinicians, and researchers continue to explore ways to evaluate new tools and bring them into the hands and homes of those most at risk of HIV acquisition. The HIV self-test may be an important step forward on this path.

References

  1. CDC. Monitoring selected national HIV prevention and care objectives by using surveillance data-United States and 6 U.S. dependent areas – 2010. HIV Surveillance Supplemental Report 2012; 17 (No. 3, part A). http://www.cdc.gov/hiv/surveillance/resources/reports/2010supp_vol17no3/index.htm. [Accessed 17 August 2012]

  2. Joint United Nations Program on HIV/AIDS (UNAIDS). UNAIDSWorld AIDS Day Report 2011, 2011. http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/
    jc2216_worldaidsday_report_2011_en.pdf.

  3. Hall HI, Holtgrave DR, Maulsby C. HIV transmission rates from persons living with HIV who are aware and unaware of their infection. AIDS 2012; 26:893–896.

  4. Cohen SM, Van Handel MM, Branson BM, Blair JM, Hall HI, Hu X, et al. Vital signs: HIV prevention through care and treatment – United States. MMWR Morb Mortal Wkly Rep 2011;60:1618–1623.

  5. Office of National AIDS Policy. National HIV/AIDS Strategy. Washington, DC: Office of National AIDS Policy; 2010.

  6. WHO. Global health sector strategy on HIV/AIDS 2011–2015, 2011. http://whqlibdoc.who.int/publications/2011/9789241501651_eng.pdf. [Accessed 27 December 2012].

  7. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://www.aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. [Accessed 16 August 2012].

  8. WHO. WHO Antiretroviral Therapy for HIV Infection in Adults and Adolescents: recommendations for a Public Health Approach, 2010. http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf. [Accessed 27 December 2012].

  9. WHO. WHO Guidance on Couples HIV Testing and Counseling Including Antiretroviral Therapy for Treatment and Prevention in Serodiscordant Couples: recommendations for a Public Health Approach, 2012 April. http://apps.who.int/iris/bitstream/10665/44646/1/9789241501972_eng.pdf. [Accessed 27 December 2012].

  10. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr 2005;39:446–453.

  11. Bendavid E, Brandeau M, Wood R, Owens D. Comparative effectiveness of HIV testing and treatment in highly endemic regions [abstract 999] In: 17th Conference on Retroviruses andOpportunistic Infections. San Francisco, California; 2010.

  12. Dodd PJ, Garnett GP, Hallett TB. Examining the promise of HIV elimination by 'test and treat' in hyperendemic settings. AIDS 2010; 24:729–735.

  13. Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet 2009; 373:48–57.

  14. Wagner BG, Blower S. Voluntary universal testing and treatment is unlikely to lead to HIV elimination: a modeling analysis. Nat Precedings 2009. http://precedings.nature.com/documents/3917/version/1/files/npre20093917-1.pdf.

  15. Charlebois ED, Das M, Porco TC, Havlir DV. The effect of expanded antiretroviral treatment strategies on the HIV epidemic among men who have sex with men in San Francisco. Clin Infect Dis 2011; 52:1046–1049.

  16. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365:493–505.

  17. Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, et al. Estimated HIV incidence in the United States. PLoS One 2011; 6:e17502.

  18. Walensky RP, Paltiel AD. Rapid HIV testing at home: does it solve a problem or create one? Ann Intern Med 2006; 145:459–462.

  19. Myers JE, Bodach S, Cutler B, Shepard C. Acceptability of home self-test kits for HIV in New York City, 2006 [abstract 121]. IDWeek: San Diego, California; 2012.

  20. Mackellar DA, Hou SI, Whalen CC, Samuelsen K, Sanchez T, Smith A, et al. Reasons for not HIV testing, testing intentions, and potential use of an over-the-counter rapid HIV test in an internet sample of men who have sex with men who have never tested for HIV. Sex Transm Dis 2011; 38:419–428.

  21. Greacen T, Friboulet D, Blachier A, Fugon L, Hefez S, Lorente N, et al. Internet-using men who have sex with men would be interested in accessing authorised HIV self-tests available for purchase online. AIDS Care 2013; 25:49–54.

  22. Greacen T, Friboulet D, Fugon L, Hefez S, Lorente N, Spire B. Access to and use of unauthorised online HIV self-tests by internet-using French-speaking men who have sex with men. Sex Transm Infect 2012; 88:368–374.

  23. Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in healthcare settings.MMWRRecomm Rep 2006; 55:1–17; quiz CE11–CE14..

  24. Workowski KA, Berman S. Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep 2010;59:1–110.

  25. Oster AM, Miles IW, Le BC, DiNenno RE, Wiegand AW, Heffelfinger JD, Wolitski R. HIV testing among men who have sex with men – 21 cities, United States, 2008. MMWR MorbMortal Wkly Rep 2011; 60:694–699.

  26. Katz D, Golden M, Hughes J, Farquhar C, Stekler J. Acceptability and ease of use of home self-testing for HIV among MSM [abstract 1131]. In: 19th Conference on Retroviruses andOpportunistic Infections (CROI). Seattle, WA; 2012.

  27. Branson B. HIV diagnosis: new tests, new algorithms [Paper 114]. In: 19th Conference on Retroviruses and OpportunisticInfections. Seattle, Washington; 2012.

  28. Carballo-Dieguez A, Frasca T, Dolezal C, Balan I. Will gay and bisexually active men at high risk of infection use over-the-counter rapid HIV tests to screen sexual partners? J Sex Res 2012; 49:379–387.

  29. Carballo-Dieguez A, Frasca T, Balan I, Ibitoye M, Dolezal C. Use of a rapid HIV home test prevents HIV exposure in a high risk sample of men who have sex with men. AIDS Behav 2012;16:1753–1760; http://dx.doi.org/10.1080/00224499.2011.647117. [Accessed 16 August 2012].

  30. Branson BM, Stekler JD. Detection of acute HIV infection: we can't close the window. J Infect Dis 2012; 205:521–524.

  31. Masciotra S, McDougal JS, Feldman J, Sprinkle P, Wesolowski L, Owen SM. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections. J Clin Virol 2011;52 (Suppl 1):S17–S22.

  32. Pilcher CD, Price MA, Hoffman IF, Galvin S, Martinson FE, Kazembe PN, et al. Frequent detection of acute primary HIV infection in men in Malawi. AIDS 2004; 18:517–524.

  33. Shepard CW, Gallagher K, Bodach SD, Kowalski A, Terzian AS, Begier E, et al. Acute HIV infection – New York City, 2008. MMWR Morb Mortal Wkly Rep 2009; 58:1296–1299.

  34. Stekler JD, Swenson PD, Coombs RW, Dragavon J, Thomas KK, Brennan CA, et al. HIV testing in a high-incidence population: is antibody testing alone good enough? Clin Infect Dis 2009;49:444–453.

  35. Wright AA, Katz IT. Home testing for HIV. N Engl J Med 2006;354:437–440.

  36. Branson BM. Home sample collection tests for HIV infection. JAMA 1998; 280:1699–1701.

  37. Colfax GN, Lehman JS, Bindman AB, Vittinghoff E, Vranizan K, Fleming PL, et al. What happened to home HIV test collection kits? Intent to use kits, actual use, and barriers to use among persons at risk for HIV infection. AIDS Care 2002; 14:675–682.

  38. CDC. Approval of a rapid test for HIV antibody. MMWR MorbMortal Wkly Rep 2002; 51:1051–1052.

  39. CDC. CLIA Certificate of Waiver fact sheet. http://www.cdc.gov/hiv/topics/testing/resources/factsheets/roltclia.htm. [Accessed 16 August 2012].

  40. Hutchinson AB, Branson BM, Kim A, Farnham PG. A metaanalysis of the effectiveness of alternative HIV counseling and testing methods to increase knowledge of HIV status. AIDS 2006; 20:1597–1604.

  41. Cohall A, Dini S, Nye A, Dye B, Neu N, Hyden C. HIV testing preferences among young men of color who have sex with men. Am J Public Health 2010; 100:1961–1966.

  42. Phillips KA, Chen JL. Willingness to use instant home HIV tests: data from the California Behavioral Risk Factor Surveillance Survey. Am J Prev Med 2003; 24:340–348.

  43. GaydosCA,HsiehYH,HarveyL,BurahA,WonH,Jett-GoheenM, et al. Will patients 'opt in' to perform their own rapid HIV test in the emergency department? Ann Emerg Med 2011; 58:S74–78.

  44. Choko AT, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, et al. The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi. PLoS Med 2011; 8:e1001102.

  45. Ng OT, Chow A, Lee V, Chen M, Lin L, Chua A, et al. Accuracy and user-acceptability of HIV self-testing using an oral fluid HIV rapid test [abstract 1075] In: 18th Conference on Retroviruses and Opportunistic Infections. Boston, Massachusetts; 2011.

  46. Asia Pacific Foundation of Canada. MedMira Launches Rapid HIV Test in Hong Kong, Macao; 2005. http://www.asiapacific.ca/fr/news/medmira-launches-rapid-hiv-test-hong-kong-macao. [Accessed 18 August 2012].

  47. INTEC; 2012. http://selfdetect.com/en/index.html. [Accessed 16 August 2012].

  48. HMGovernment. The HIV Testing Kits and Services Regulations 1992. http://www.legislation.gov.uk/uksi/1992/460/contents/made. [Accessed 16 August 2012].

  49. Commonwealth of Australia. 2011 National HIV Testing Policy. http://testingportal.ashm.org.au/resources/Australian_National_HIV_Testing_Policy_v1-1.pdf. [Accessed 16 August 2012].

  50. Food and Drug Administration (FDA). Vital facts about HIV home test kits. http://www.cdc.gov/hiv/topics/testing/rapid/rtcomparison.htm. [Accessed 16 August 2012].

  51. Blood Products Advisory Committee (BPAC). Transcript of the BPAC 85th Meeting: November 3, 2005. http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4190t1.htm.

  52. BPAC. Transcript of the BPAC 86th Meeting: March 10, 2006. http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006- 4206t2.pdf. [Accessed 17 August 2012].

  53. OraSure Technologies. OraSure Makes Final FDA Submission for Approval of Over-the-Counter Rapid HIV Test (press release). http://phx.corporate-ir.net/phoenix.zhtml?c=99740&p=irol-corpnewsArticle&ID=1643909&highlight=. [Accessed 18 August 2012].

  54. FDA. OraQuick In-Home HIV Test Summary of Safety and Effectiveness; 2012. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/
    PremarketApprovalsPMAs/UCM312534.pdf. [Accessed 17 August 2012].

  55. OraSure Technologies. Final Advisory Committee Briefing Materials: available for Public Release: OraQuick In-Home HIV Test. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
    BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM303652.pdf. [Accessed 18 August 2012].

  56. Forshee RA. Model to estimate the public health benefits and risks of the OraQuick In-Home HIV Test kit based on its performance in phase III trials; 2012. http://fda.yorkcast.com/webcast/Viewer/?peid=ba104b31fe4c4c099568bacda9a4e5401d. [Accessed 17 August 2012].

  57. Paltiel AD, Walensky RP. Home HIV testing: good news but not a game changer. Ann Intern Med 2012; 157:744–746.

  58. Mavedzenge SN, Baggaley R, Ru Lo Y, Corbett EL. HIV selftestingamong health workers: a review of the literature anddiscussion of current practices, issues, and options for increasingaccess to HIV testing in Sub-Saharan Africa. In. Geneva: World Health Organization (WHO); 2011.

  59. Richter M, Venter WD, Gray A. Home self-testing for HIV: AIDS exceptionalism gone wrong. S AfrMed J 2010; 100:636–642.

  60. Campbell S, Klein R. Home testing to detect human immunodeficiency virus: boon or bane? J Clin Microbiol 2006; 44:3473–3476.

  61. Marzuk PM, Tierney H, Tardiff K, Gross EM, Morgan EB, Hsu MA, et al. Increased risk of suicide in persons with AIDS. JAMA 1988; 259:1333–1337.

  62. Cote TR, Biggar RJ, Dannenberg AL. Risk of suicide among persons with AIDS. A national assessment. JAMA 1992;268:2066–2068.

  63. Dannenberg AL, McNeil JG, Brundage JF, Brookmeyer R. Suicide and HIV infection. Mortality follow-up of 4147 HIVseropositive military service applicants. JAMA 1996; 276:1743–1746.

  64. Perry SW, Jacobsberg LB, Fishman B, Weiler PH, Gold JW, Frances AJ. Psychological responses to serological testing for HIV. AIDS 1990; 4:145–152.

  65. Branson BM. The future of HIV testing. J Acquir Immune DeficSyndr 2010; 55 (Suppl 2):S102–S105.

  66. Louie B, Pandori MW, Wong E, Klausner JD, Liska S. Use of an acute seroconversion panel to evaluate a third-generation enzyme-linked immunoassay for detection of human immunodeficiency virus-specific antibodies relative to multiple other assays. J Clin Microbiol 2006; 44:1856–1858.

  67. Wawer MJ, Gray RH, Sewankambo NK, Serwadda D, Li X, Laeyendecker O, et al. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis 2005; 191:1403–1409.

  68. Ventuneac A, Carballo-Dieguez A, Leu CS, Levin B, Bauermeister J, Woodman-Maynard E, et al. Use of a rapid HIV home test to screen sexual partners: an evaluation of its possible use and relative risk. AIDS Behav 2009; 13:731–737.

  69. Paltiel AD, Pollack HA. Price, performance, and the FDA approval process: the example of home HIV testing. Med DecisMaking 2010; 30:217–223.

  70. Denning P, DiNenno E. Communities in crisis: is there a generalized HIV epidemic in impoverished urban areas of the United States? [abstract WEPDD101]. In: XVIII InternationalAIDS Conference. Vienna, Austria; 2010.

  71. An Q, Prejean J, McDavid Harrison K, Fang X. Association between community socioeconomic position and HIV diagnosis rate among adults and adolescents in the United States 2005 to 2009. Am J Public Health 2013; 103:120–126.

  72. de la Fuente L, Rosales-Statkus ME, Hoyos J, Pulido J, Santos S, Bravo MJ, et al. Are participants in a street-based HIV testing program able to perform their own rapid test and interpret the results? PLoS One 2012; 7:e46555.

  73. Katz DA, Golden MR, Stekler JD. Use of a home-use test to diagnose HIV infection in a sex partner: a case report. BMC ResNotes 2012; 5:440.

  74. Gray R, Kigozi G, Kong X, Ssempiija V, Makumbi F, Wattya S, et al. The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow up study in Rakai, Uganda. AIDS 2012; 26:609–615.

  75. Sonder GJ, Prins JM, Regez RM, Brinkman K, Mulder JW, Veenstra J, et al. Comparison of two HIV postexposure prophylaxis regimens among men who have sex with men in Amsterdam: adverse effects do not influence compliance. Sex Transm Dis 2010; 37:681–686.

  76. Colfax GN, Buchbinder SP, Cornelisse PG, Vittinghoff E, Mayer K, Celum C. Sexual risk behaviors and implications for secondary HIV transmission during and after HIV seroconversion. AIDS 2002; 16:1529–1535.

  77. National Institutes of Health (NIH). Home self-testing for HIV to increase HIV testing frequency in men who have sex with men (The iTest Study). In: ClinicalTrials.gov website; 2011. http://clinicaltrials.gov/ct2/show/NCT01161446?term=NCT01161446&rank=1. [Accessed 18 August 2012].

  78. Sharma A, Sullivan PS, Khosropour CM. Willingness to take a free home HIV test and associated factors among internetusing men who have sex with men. J Int Assoc Physicians AIDSCare (Chic) 2011; 10:357–364.

  79. Wayal S, Llewellyn C, Smith H, Fisher M. Home sampling kits for sexually transmitted infections: preferences and concerns of men who have sex with men. Cult Health Sex 2011; 13:343–353.

  80. Kimbrough LW, Fisher HE, Jones KT, Johnson W, Thadiparthi S, Dooley S. Accessing Social Networks with High Rates of Undiagnosed HIV infection: the Social Networks Demonstration Project. Am J Public Health 2009; 99:1093–1099.

  81. Spielberg F, Levine RO, Weaver M. Self-testing for HIV: a new option for HIV prevention? Lancet Infect Dis 2004; 4:640–646.

  82. National AIDS and STI Control Programme. Guidelines for HIVtesting and counseling in Kenya. Nairobi, Kenya: Ministry of Public Health and Sanitation; 2010.

  83. Rosenberg NE, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, et al. Detection of acute HIV infection: a field evaluation of the determine(R) HIV-1/2 Ag/Ab combo test. J Infect Dis 2012; 205:528–534.

Source

June 25, 2013

June 27 is National HIV Testing Day

Provided by Infection Control Today

Posted Yesterday

The Centers for Disease Control and Prevention (CDC) recommends human immunodeficiency virus (HIV) testing for everyone at least once as a part of routine healthcare, and for high-risk groups more often.

This year marks the 19th annual National HIV Testing Day, a time to promote one of the best tools for HIV prevention. Too many people don’t know they have HIV; more than 1 million people are living with HIV in the United States, but 1 in 5 don’t know they are infected.

In April 2013, the U.S. Preventive Services Task Force (USPSTF) released HIV testing recommendations that everyone aged 15 to 65 should be screened for HIV infection; teens younger than age 15 and adults older than 65 also should be screened if they are at increased risk for HIV infection; and all pregnant women, including women in labor who do not know if they are infected with HIV, should be screened for HIV infection. CDC recommends an HIV test once a year for people at increased risk—such as gay and bisexual men, people who inject drugs, or people with multiple sex partners. CDC data suggests that sexually active gay and bisexual men might benefit from more frequent testing (e.g., every 3 to 6 months) Regular testing allows people who have HIV to know their status, get life-saving treatment and care, and prevent HIV transmission to others.
It’s easy to get tested. Ask your doctor for a test, or find a nearby testing site through National HIV and STD Testing Resources. Home test kits are also available. Two FDA-approved tests are available online or from drugstores: a rapid testing kit that provides results in 20 minutes using a swab of oral fluid from your gums, and a kit that involves collecting a finger stick blood sample and sending it to a licensed laboratory, then calling in later for results. In both cases, testing is anonymous, and the manufacturer provides confidential counseling and referral to care.

When you know your status, you can take care of yourself. If you find out that you are infected with HIV (if you test positive), you can seek medical care and get treatment, which helps people with HIV live longer, healthier lives and also lowers the chances of passing HIV to others.

If you don’t have HIV (if you test negative), take steps to stay negative. Remember that if you have unprotected sex or share needles for drug use after your test, you need to get tested again to make sure you are still HIV-negative. Your HIV test result “expires” every time you have risky sex or share needles or related works.

Knowing your HIV status is empowering. When you know your status, you can take care of yourself.

The CDC continues to work with federal, state, and local partners to expand routine HIV testing—not just on National HIV Testing Day but all year long. In 2010, CDC implemented new phases of its successful Expanded Testing Initiative, funding 30 health departments to focus on increasing HIV testing among African Americans and Latinos as well as gay and bisexual men and injection drug users of all races and ethnicities. The men who have sex with men (MSM) Testing Initiative will identify MSM with HIV who were previously unaware of their infection and link them to HIV medical care.

CDC’s Act Against AIDS (AAA) campaigns work to further expand HIV testing, raise awareness about HIV and AIDS among all Americans, and reduce the risk of infection among the hardest-hit populations.
- Reasons/Razones, the newest AAA campaign, promotes HIV testing among gay and bisexual Latino men.
- Let’s Stop HIV Together, a general-awareness AAA campaign to reduce stigma, urges everyone to “get the facts, get tested, and get involved.”
- Testing Makes Us Stronger encourages African American gay and bisexual men to get tested for HIV.
- Take Charge. Take the Test. encourages African American women to get tested for HIV.

On this National HIV Testing Day and throughout the year, people can:

- Get tested for HIV. Ask your doctor for a test, check National HIV and STD Testing Resources for a nearby testing site, call 1-800-CDC-INFO, text your ZIP code to “KNOW IT” (566948), or use one of the home testing kits.

- Get tested once a year or more often if you have multiple sex partners, inject drugs, or are a man who has sex with other men.

- Lower your risk for getting HIV by having sex with only one partner whom you know is not infected, or using a condom every time you have anal, vaginal or oral sex.

- If you have HIV, get medical care as soon as possible to stay healthier longer and to keep from passing the virus to others.

Healthcare providers can:
- Offer patients HIV tests as a routine part of their healthcare.

- Test women for HIV each time they are pregnant.

- Connect people at high risk for HIV to services that help them lower their risk and prevent them from getting infected.

- Make sure people who have HIV get treatment and the services they need to stay healthy and lower their risk of passing the virus to others.

Download materials for healthcare providers from CDC’s Act Against AIDS website.

State and local health departments can:

- Coordinate National HIV Testing Day awareness and testing events to help prevent the spread of HIV and build a local network that responds year-round to the epidemic.

- Create programs and adopt policies to get people at high risk tested early and often. Make sure that those who have a positive test get care quickly.

- Provide services such as medical care, social services, and programs shown to change behavior and lower risk to people at risk for HIV and those living with HIV.

- Promote and use national referral systems for places to get tested, such as National HIV and STD Testing Resources.

- Use CDC’s Act Against AIDS materials to promote HIV testing in target populations.

A Twitter chat with CDC director Thomas Frieden will take place on June 27, 2013, from 2 p.m. to 3 p.m.. ET. Use #CDCchat.

Source: CDC

Source

June 24, 2013

National HIV Testing Day: What You Need to Know

NHTDhdrSeal

Learn why it’s important to get tested for HIV and discover ways to raise awareness on National HIV Testing Day, celebrated on June 27th.

By Amy Boulanger | Jun 24, 2013 12:14 PM EDT

According to the Centers for Disease Control and Prevention (CDC), nearly 1.1 million people are living with HIV (human immunodeficiency syndrome), and one in five are unaware that they are infected.

National HIV Testing Day (NHTD) was created to encourage people to get tested for HIV and seek medical care to live healthy lives and reduce the risk of spreading the infection to others. It was first observed on June 27, 1995. "Take the Test, Take Control."

Who Should Be Tested?

Many people with HIV don't present symptoms. They may not feel or look sick but are carrying the infection inside their body. That's why it's important to get tested so the infection is not passed to someone else.

Everyone between the ages of 15 to 65 should get tested for HIV at least once. All pregnant women should get tested.

HIV Testing

There is no cure for HIV. However, there have been great strides in the medications used to treat HIV. These medications can limit or slow the destruction of the immune system, improve health, and possibly reduce a person's ability to pass HIV to someone else.

Testing is quick and easy. The most common HIV tests use blood to detect an infection. Tests using saliva or urine are also available. Tests can take up to a few days for results. But rapid testing can show results in about 20 minutes.

All positive HIV tests must be followed up by another test to confirm the result.

Where To Get Tested

You can find an HIV testing location in various places:

  • HIV testing centers
  • health departments
  • hospitals
  • private doctors' offices
  • clinics

Find a testing site near you.

How is HIV spread?

The most common factors in the spread of HIV include:

  • Not using a condom. It is extremely risky to have unprotected sex with someone who has HIV.
  • Unprotected anal sex. This type of sex is riskier than unprotected vaginal sex.
  • Multiple sex partners.
  • Unprotected oral sex. Though it's a lower risk than anal or vaginal sex, this can also be a risk for HIV transmission.
  • Sharing drugs with needles.
  • Having another sexually transmitted infection (STI).
  • Being born to an infected mother. HIV can be passed from mother to child during pregnancy, birth, or breast-feeding.

Other less common factors may include:

  • Receiving blood transfusions, blood products, or organ/tissue transplants that are contaminated with HIV. This risk is extremely remote due to the rigorous testing of the U.S. blood supply and donated organs/tissue.
  • Unsafe or unsanitary injections. HIV may also be transmitted through unsanitary injections or other medical or dental practices. The risk, however, is extremely low thanks to current safety standards in the United States.
  • Eating food that has been pre-chewed by an infected person. This is a rare mode of HIV transmission, and has only been documented among infants whose caregiver gave them pre-chewed food.
  • Being bitten by a person with HIV. While very rare, there have been some documented cases of HIV transmission from a human bite, which involved severe trauma and blood. There is no risk of transmission if the skin is not broken.
  • Contact between broken skin, wounds, or mucous membranes and HIV-infected blood or blood-contaminated body fluids — an extremely rare method of transmission.
  • Tattooing or body piercing. While no cases of HIV transmission from tattooing or body piercing have been documented, it's still safe to use sterile equipment.
  • "French" or deep, open-mouth kissing. This is an extremely rare way of contracting HIV, but could potentially be passed from an HIV-infected person if the HIV-infected person's mouth or gums are bleeding.
How Can You Raise Awareness?

There are many ways that you can help spread HIV awareness.

Host a fundraising or community event, such as a run or walk, to raise money for a local HIV organization.

Send Twitter posts.

  • Sample Tweets:
    • Today is National HIV Testing Day. Take the test, take control. Find HIV testing & services near you: http://1.usa.gov/9h37x0 #NHTD
    • One in five people living with #HIV in the U.S. don't know they have it. Get tested: http://1.usa.gov/VqGcRW #NHTD

Make a website announcement to encourage people to get tested.

Learn more about the National HIV/AIDS strategy.

Source

June 22, 2013

Better Testing Catches Early HIV Infection

40017

By Michael Smith, North American Correspondent, MedPage Today

Published: June 21, 2013

Action Points

  • New approaches to HIV testing can detect acute infections that would have gone undetected with older methods.
  • Note that new 4th-generation tests detect both immunoglobulin M-class and G-class antibodies as well as the p24 antigen whereas early immunoassays detected only immunoglobulin G-class antibodies to HIV.

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

New approaches to HIV testing can detect acute infections that would have gone undetected with older methods, according to a CDC report.

A 4th-generation immunoassay, coupled with an HIV-1/HIV-2 antibody differentiation test, picked up acute infections where traditional methods did not, according to two studies reported by CDC in the June 20 issue of Morbidity and Mortality Weekly Report.

The acute phase of infection -- which plays a "disproportionate" role in transmission -- is the period between the appearance of HIV RNA in plasma and the detection of HIV antibodies, the agency noted.

Testing for HIV has usually begun with an immunoassay, followed by a Western blot or indirect immunofluorescence assay if the initial test is positive.

Early immunoassays detected only immunoglobulin G-class antibodies to HIV. That was improved so that 4th-generation tests detect both immunoglobulin M-class and G-class antibodies as well as the p24 antigen, an important HIV protein.

Because the p24 antigen can be detected before antibodies appear, the 4th-generation tests can pick up some acute HIV infections, the agency report noted.

But a negative supplemental test with a Western blot or indirect immunofluorescence assay has often resulted in erroneously classifying people as HIV-negative, the report added.

Two evaluations of the new test algorithm suggest it is likely to do better:

  • HIV screening at a Phoenix emergency department identified 37 undiagnosed HIV infections from July 2011 through February 2013, including 12 (or 32.4%) in the acute phase that would not have been found using earlier methods.
  • A three-site screening program found 99 cases with a positive first test and a negative supplemental test; 55 (or 55.6%) were shown to be acute HIV infections but a large proportion of those would not have been found by traditional methods.

The new algorithm begins with a 4th-generation immunoassay, followed by the HIV-1/HIV-2 antibody test. If that second assay is negative or indeterminate, the definitive step is testing for the presence of HIV RNA.

In the Phoenix emergency room, the agency reported, the first test found 37 cases of infection, including 25 in which the supplemental test was positive and 12 in which it was negative or indeterminate.

RNA testing confirmed acute HIV infection in those 12, the CDC report said.

The median HIV viral load among those 12 was 3,636,176 copies of HIV RNA per milliliter, compared with 27,125 copies per milliliter among the 25 with established infection, the report said.

In the Screening Targeted Populations to Interrupt On-going Chains of HIV Transmission with Enhanced Partner Notification (STOP) study, initial testing of 37,876 patients, screened from September 2011 through September 2012, found HIV in 654, or 1.7%.

Of those, 99 had a negative or indeterminate result on the HIV-1/HIV-2 antibody differentiation test, but HIV RNA was present in 55, indicating an acute infection. The traditional supplemental tests -- Western blot or indirect immunofluorescence assay -- were negative in 37 cases and indeterminate in seven, the agency reported.

Taken together, the agency report said, the findings show that acute HIV infection detected with newer immunoassays is often misclassified as HIV-negative by traditional supplemental tests, "potentially leading to adverse clinical outcomes for patients and further HIV transmission within the community."

The researchers cautioned that the findings might not apply to all screening programs. The Phoenix program aimed to screen as many people as possible, but some tests might have been ordered because of an increased index of suspicion.

And the STOP study looked at people at high risk for HIV, so that the proportion of infections that were acute might be higher than in other populations, the agency report noted.

The analysis was supported by the CDC. Peters is an employee of the agency.

Primary source: Morbidity and Mortality Weekly Report
Source reference:
Centers for Disease Control and Prevention "Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing algorithm -- United States, 2011–2013" MMWR 2013; 62: 489-494.

Source

June 5, 2013

AHF Launches First 1-minute “INSTI” HIV Testing Program in New York City

ahf_2011_withname_thumbnail

June 05, 2013 09:00 AM Eastern Daylight Time 

AIDS Healthcare Foundation will launch the program at the Brooklyn Pride Festival on Saturday, June 8th, offering free one-minute results HIV tests through two mobile testing units

1-minute “INSTI” testing will be available on an ongoing basis through AHF’s new Out of the Closet Thrift Store in Brooklyn and through its mobile testing program

NEW YORK--(BUSINESS WIRE)--On Saturday, June 8th, AIDS Healthcare Foundation (AHF) will make history as the first HIV testing program in New York City to use a revolutionary HIV test that provides results to people in just one minute. The program will be launched at the 17th annual Brooklyn Pride Festival where free testing will be offered out of AHF’s mobile testing unit and the visiting Condom Nation van throughout the festival from 11:00 am to 5:00 pm. Free, confidential 1-minute INSTI testing will be available on an ongoing basis at AHF’s new Out of the Closet Thrift Store in Brooklyn (475 Atlantic Ave.) every Monday-Saturday from 10:00 am to 7:00 pm beginning on Monday, June 10th. AHF is a proud sponsor of this year’s Brooklyn Pride.

 

What:  

AHF launches 1-minute HIV testing at Brooklyn Pride Festival

     
When:  

SATURDAY, June 8th 11:00 am to 5:00 pm

     
Where:  

Brooklyn Pride Festival

    Park Slope on 5th Avenue from 3rd to 9th Streets
    AHF booth will be located at 5th Ave. between 4th and 5th Streets
     
Who:  

Michael Camacho, MPH, NYC Regional Director, AIDS Healthcare Foundation

    AHF HIV testing counselors
     
B-roll:   Mobile testing unit and Condom Nation van offering free INSTI HIV testing
     
Contacts:  

Michael Camacho, AHF NYC Regional Director, mobile 646.265.7460

   

Lori Yeghiayan Friedman, AHF Assoc. Dir. of Communications, mobile 323.377.4312

Last September, AHF was the first HIV testing program in the United States to use the revolutionary HIV test when it launched a program to offer it at all of its Los Angeles locations last September. AHF now offers the test at many of its locations throughout Florida as well. For more information about AHF’s testing locations in New York and other parts of the U.S., please visit: www.freehivtest.net.

“With an estimated 15% of people who are HIV-positive unaware of their status, our hope is that the INSTI one-minute test removes a barrier that prevents people from getting tested regularly,” said Michael Camacho, NYC Regional Director for AHF. “Though the 1-minute test has been widely deployed in other countries in Africa and elsewhere over the past four years, it has only been available in the U.S. since last September. Unlike other tests that take 15 to 30 minutes for results, the INSTI™ test produces results in as little as 60 seconds—a revolution for testing in the U.S. – and, now, New York!”

bioLytical Laboratories’ one-minute HIV test, the INSTI™ Rapid HIV Test, was approved for widespread use in the United States in late July 2012 by the Food and Drug Administration (FDA). At the time, Whitney Engeran-Cordova, Senior Director of AHF’s Public Health Division, said, “The increased availability of the INSTI™ 60-second rapid test in the U.S. … is a game-changer and will allow for large-scale testing events and new ways for point-of-care testing in Emergency Rooms. Most importantly, it will lead to new techniques to reach people.”

According to a bioLytical statement of the time of FDA approval in July, “The INSTI™ Rapid HIV Antibody Test is the first rapid HIV test to meet the stringent requirements of the updated Clinical Laboratory Improvement Amendments (CLIA) guidelines, which pertain to the complexity of laboratory tests. A CLIA Waived test is categorized as a ‘simple laboratory examination or procedure that has an insignificant risk of an erroneous result,’ meaning the tests can be performed by untrained users at point-of-care (POC) locations across the country.” bioLytical also noted, “The INSTI™ Rapid HIV-1 Antibody Test, the world’s only proven 60-second test for HIV/AIDS, is being made more widely available to the U.S. population. Found to meet the CLIA Waived performance requirements for finger-stick blood samples, INSTI™ can now be used by HIV testers and healthcare providers in a significantly expanded variety of settings.”

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 200,000 individuals in 28 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Contacts

AIDS Healthcare Foundation
Lori Yeghiayan Friedman
AHF Assoc. Director of Communications
Telephone: 323-308-1834
Mobile: 323-377-4312
loriy@aidshealth.org
or
Michael Camacho, MPH
NYC Regional Director, AHF
Mobile: 646-265-7460
michael.camacho@aidshealth.org

Source

May 20, 2013

Clinical Pointers on Rapid Home-Use HIV Testing

CDC Expert Commentary

Philip J. Peters, MD

May 20, 2013

On July 3, 2012, the US Food and Drug Administration approved the OraQuick® In-Home HIV Test, a rapid home-use HIV test kit that can be purchased over the counter and online. The kit provides a test result in 20-40 minutes and allows patients to conduct a self-test in their own home. The kit, which tests a sample of fluid from the mouth, is approved for sale in stores and online to anyone age 17 years and older.

Given the availability of a home-use HIV test, should primary care clinicians advise their patients to use this test, and in what situations is it expected to be most useful?

The Centers for Disease Control and Prevention (CDC) recommends HIV screening for all persons aged 13-64 years, regardless of risk, in healthcare settings where the prevalence of undiagnosed HIV is ≥ 0.1% or the yield of screening is at least 1 new HIV infection identified per 1000 persons screened.[1]

Annual HIV testing is recommended for those at high risk for HIV infection. The best approach for patients is to go to a physician and get tested as part of regular medical care, which is what the CDC recommends. Home-use self-testing is not a substitute for getting tested by a healthcare provider. Primary care clinicians should continue to encourage their patients to get tested for HIV.

Some patients might be reluctant or reticent to test for HIV with their provider or prefer the convenience of HIV testing at home.[2] Having access to a home-use, over-the-counter HIV test could lead to increased HIV testing and earlier HIV diagnoses among people who are not currently getting tested for HIV. If so, it will be an important advance.

Some patients at high risk for HIV infection may benefit from frequent (every 3-6 months) HIV testing. For these patients, home-use self-testing might be convenient.

How should physicians counsel patients who use the home-use HIV test?

It is important for patients to read and follow the test instructions carefully. Performing the test incorrectly can result in an invalid (uninterpretable) test result. In a clinical study, 1% of people who took the test did not get an interpretable test result.[3] A 24/7 support center toll-free number is provided with the test instructions in case there are any questions about how to perform the test correctly. Patients should be aware that in a clinical study, the home-use HIV test did not detect every HIV infection. Among people determined to have HIV infection, approximately 1 in 12 had a negative home-use HIV test result (8% rate of false negative results),[3] so patients should be counseled that a negative home-use HIV test result does not completely rule out HIV infection. Compared with a blood test performed by a healthcare provider, there is a trade-off for the convenience of self-testing oral fluid at home.

Patients should also be aware that this test does not detect recent HIV infection. This test detects antibodies against HIV approximately 3 months after infection occurred. Patients who are concerned about very recent HIV exposure should discuss this with their healthcare provider to determine whether medication to prevent HIV infection (eg, antiretroviral postexposure prophylaxis for HIV exposures within 72 hours) or diagnostic tests for early HIV infection (eg, a fourth-generation combination HIV antigen/antibody test or an HIV RNA test) are indicated.

Is additional HIV testing recommended for patients who report a positive home-use HIV test result?

Like any rapid test, a positive or reactive home-use, over-the-counter HIV test is a preliminary positive result that needs to be confirmed with additional testing. HIV testing always involves at least 2 tests. Patients who report a positive home-use HIV test should be counseled that they have a preliminary positive test result and must have blood drawn and sent to a laboratory for HIV testing to determine whether HIV infection is truly present or whether the test result is a false positive. (In clinical studies, only 1 false positive result occurred in 4903 tests on HIV-negative people.[3]) Patients with a confirmed positive HIV test result should be immediately referred for HIV medical care.

Given the high rate of false negative results, when should a clinician consider retesting a patient who reports a negative home-use HIV test result?

Self-testing for HIV at home is not intended as a substitute for going to a healthcare provider and getting tested. Patients who are concerned that they might have been exposed to HIV should be offered an HIV test even if they report a negative home-use test result. The clinical trials showed that the home-use HIV test was positive in 92% of persons who were infected. This is not as accurate as a blood test performed by a healthcare provider. Also, the home-use HIV test does not detect recent HIV infection (less than 3 months after exposure). Some laboratory tests (fourth-generation combination antigen/antibody tests or HIV RNA tests) can detect HIV as soon as 10-14 days after infection. Patients who might have been exposed to HIV very recently (that is, within 72 hours) also should be evaluated for possible use of postexposure prophylaxis with antiretroviral drugs. In addition, patients with ongoing potential exposures to HIV infection should be retested at least annually. Some patients, such as sexually active men who have sex with men, might benefit from testing as often as every 3-6 months. Therefore, the decision to repeat HIV testing should be based on the patient's specific circumstances.

How should clinicians advise partners of high-risk individuals about taking the home-use HIV test?

Partners of people at high risk for HIV infection are an important group to test for HIV infection. Clinicians with patients at high risk for HIV infection should encourage them to discuss HIV testing with their partners and urge their partners to be tested for HIV infection as well. Ideally, these partners could come to your office and receive HIV testing as part of their medical care. Further information on finding an HIV testing site is also available online. Some partners, however, may be reluctant or reticent to test for HIV because of perceived stigma or other reasons. In addition, some couples may prefer to test together, and HIV testing at home offers a convenient way to do that. Patients should be reminded that self-testing for HIV at home does not detect recent HIV infection (less than 3 months after exposure). Because individuals with recent HIV infection are at especially high risk for transmitting HIV infection to their partners, a negative home-use HIV test should not be used to make decisions about behaviors, such as having unprotected sex, that might place them at risk for HIV.

Web Resources

For information on CDC's HIV screening recommendations in healthcare settings: http://www.cdc.gov/actagainstaids/hssc/index.html

For general information on HIV testing: http://www.hivtest.org/

For general information on HIV infection: http://www.cdc.gov/hiv/default.htm

Philip J. Peters, MD, DTM&H, is a Medical Officer with the Division of HIV/AIDS Prevention, US Centers for Disease Control and Prevention, in Atlanta, Georgia. Dr. Peters is the activity leader for HIV testing in the Division of HIV/AIDS Prevention's Epidemiology Branch. He is responsible for conducting epidemiologic and biomedical research activities to evaluate acute HIV infection and important HIV-related coinfections such as Staphylococcus aureus, influenza, and hepatitis B virus. Dr. Peters received his medical degree from Cornell University Medical College. He completed his clinical training in internal medicine at Massachusetts General Hospital and his clinical training in infectious diseases at Emory University. He began his career at the CDC in 2006 when he joined as an Epidemic Intelligence Service Officer. His professional interests include improving HIV diagnosis in the clinical setting.

References

Source