Siegel, Marc MD*†; Kennedy, Leigh MD*†; Rexroth, Karen BS*; Lankford, Margaret NP*; Turner, Melissa MSW*; McKnight, Angela APRN-BC*; Cummins, Shirley BS*; Benator, Debra MD*†; Kan, Virginia MD*†
Within the United States, 1.4 million people were estimated to have HIV infection in 2007,1 and an estimated 21%-27% of infected persons were unaware of their diagnosis.2,3 Alarmingly, in 2008, the estimate of cases of HIV/AIDS in the United States was increased from approximately 40,000 annual new infections since 19982 to a new estimate of 56,300 new infections in 2006,1 of which about 17,280 cases were thought to be due to transmission from persons unaware of their HIV status.4 Among new cases from 1994 to 1999, the Centers for Disease Control (CDC) has shown that 41% will develop AIDS within a year of their diagnosis.5 The CDC revised its recommendations in 2006 for HIV screening to be performed routinely for all patients aged 13-64 years, unless the prevalence of undiagnosed HIV infection in the community is below 0.1%.6 The American College of Physicians published their guidance statement in January 2009 for clinicians to adopt HIV screening as part of routine medical care, to encourage patients to be tested, and to determine the need for repeat screening on an individual patient basis.7
The first rapid HIV-1 antibody test kit was approved by the Food and Drug Administration in November 2002. There are currently 6 rapid test kits for HIV screening, providing results within 30 minutes. The use of rapid HIV antibody tests facilitates patients being informed of their screening results during their initial encounter8 and, in some settings, has resulted in an increased linkage to medical care for those with reactive screening tests.9
In 2009, District of Columbia (DC) had the highest per capita rate of HIV in the United States estimated at 3.2% of the population more than age 12 years.10 The Veterans Affairs Medical Center in Washington, District Columbia (VAMC-DC), is a 158-bed acute tertiary care medical center providing emergency, hospital, and ambulatory care to more than 44,000 veterans in the metropolitan Washington, DC, area. Until now, inpatient HIV testing at the VAMC-DC had been predominantly targeted to patients with disclosed risk factors. We implemented a voluntary rapid HIV testing in several inpatient settings within the VAMC-DC and evaluated patient acceptance of rapid HIV testing, the percentage of patients with reactive screening tests, the prevalence of new HIV infections among those tested, and the rate of linkages to care.
This study was reviewed and approved by the Human Studies Subcommittee and the Research and Development Committee of the VAMC-DC, in accordance with the ethical standards on human studies and with the Helsinki Declaration of 1975 and its revision in 2000.
Rapid HIV screening was performed using the OraQuick Advance Rapid HIV-1/2 Antibody Test (OraSure Technologies, Bethlehem, PA) according to the manufacturer's instructions. The test kits and quality assurance controls were provided by the HIV/AIDS Administration of the District of Columbia Department of Health through their District-Wide HIV Testing Protocol. Both whole blood and oral fluid are acceptable specimens for this test kit. All personnel performing HIV screening were trained and were certified as competent to perform this Clinical Laboratory Improvement Amendments-waived assay.
From November 2007 through March 2009, staff from the Infectious Diseases Section at the VAMC-DC offered bedside educational information and rapid HIV screening to inpatients on 2 medical wards and after weekly group HIV education sessions on the mental health ward. Screening was offered on weekdays but not on weekends or federal holidays. Patients with dementia and/or severe illness interfering with their ability to make medical decisions were deemed ineligible and were not offered testing. Eligible patients were given HIV testing information and a consent form [Veterans Affairs (VA) form 10-0121]. As required by existing federal law (Public Law 100-322) at the time of our study, all patients who agreed to HIV screening had documented written informed consent with pretest counseling in private.
Whole blood samples in EDTA tubes already in the laboratory were used for testing for the medical inpatients, unless the patient requested bedside testing using oral fluid. For the mental health inpatients, testing using oral fluid was performed in a private examination room on the mental health ward. Screening results with posttest counseling were usually provided within 30 minutes of testing for patients tested using oral fluids and within 2 hours of testing for patients tested using whole blood samples, unless patients were away from their rooms or had been discharged. No patients with a reactive screening result were discharged before receiving their test results. Patients who were discharged before receiving their results were contacted by telephone and informed of their nonreactive test results. Condoms were offered at the time of hospital discharge.
Any patients with reactive rapid HIV screening tests were informed of their results, had blood drawn for Western blot confirmation, and were given condoms with transmission risk reduction education. The patients were offered additional support as needed with receipt of their initial reactive screening results. On confirmation with HIV Western blot assay, the patients underwent additional testing for CD4, HIV RNA, and genotypic antiretroviral resistance and were linked to HIV specialty care in the Infectious Diseases Clinic.
During the 17-month study period, our staff visited 4011 inpatients on 2 medical wards and on the mental health ward within the VAMC-DC to offer information about HIV and point-of-care (HIV-POC) testing (Table 1). A total of 544 inpatients were deemed ineligible for testing, and information about rapid HIV-POC testing was offered to 3467 patients. For the various reasons given in Table 1, 2643 patients declined HIV screening.
Among the 3467 eligible inpatients, 824 patients accepted testing (Table 2), representing an acceptance rate of 23.8%. The majority of patients tested (94%) were men and 46 (5.6%) were women. Those reporting race included 84% African American, 14% white, 1% Hispanic, and 0.5% Asian. The median age of tested patients was 60 years (range: 23-96 years). There were no age criteria for our HIV-POC screening, thereby allowing 268 patients (33% of those tested) beyond the 13-64 age range recommended by the CDC.6 Among those who tested, a single patient requested testing with oral fluid after his initial whole blood screening test yielded a reactive result. Results of the rapid HIV screening tests were given to 823 patients (99.9%). One patient did not receive his negative screening result before being discharged. Attempts to contact this individual were unsuccessful, as he died from a motor vehicle accident shortly after hospital discharge. Among those tested, 25% accepted condoms at the time of discharge.
Ten inpatients (1.2% of those tested) had reactive results by our rapid screening, which were all confirmed by Western blot assay. Seven of these patients represented new HIV diagnoses: 6 patients were from the medical wards and 1 patient was from the mental health ward. For 3 patients, HIV infection had been previously diagnosed outside the VA Health Care System but they had never sought HIV care within the VA. Table 3 summarizes the demographic and clinical parameters of these 10 patients with confirmed HIV infection. All patients were men, and 80% were African American. Their median age was 53.5 years (range: 25-65 years) with a single patient whose age was beyond the CDC-recommended age range for testing. Among the 7 newly diagnosed patients, the median CD4 cell count was 171 cells per cubic millimeter (range: 95-679 cells/mm3) with a median CD4 percentage of 15% (range: 10%-37%). Among the 7 newly diagnosed patients, 4 patients (57%) had CD4 cell counts below 350 cells per cubic millimeter. The median detectable HIV RNA among the 7 newly diagnosed patients was 48,013 copies per milliliter (range: 1763 to >500,000 copies/mL). Of the 5 patients with AIDS by CD4 criteria at the time of their rapid testing, 4 patients were newly diagnosed and 1 had been previously diagnosed. All 10 patients were offered linkage to HIV care, but 1 patient did not adhere to his clinic follow-up visits. Six patients began antiretroviral therapy upon linkage to care.
For comparison during the same 17-month study period, 256 conventional HIV serology tests were performed on inpatients at the VAMC-DC who had no HIV-POC screening, representing 2.6% of patients not visited by our staff (Table 2). Nine patients (3.5% of these tested) had reactive results: 8 were confirmed positive and 1 was indeterminate by Western blot assay. Of the 7515 patients hospitalized on the same 3 wards surveyed in our study, we had visited 4011 patients. Among the remaining 3504 patients who were not offered HIV screening by our team, 133 HIV serology tests were performed, representing a conventional testing rate of 3.8%. Among these patients tested, there were 7 reactive results, which were all by Western blot assay, representing a seropositivity rate of 5.3% among those tested.
With 3.2% of the residents of DC living with HIV or AIDS, this epidemic has become the top public health priority of the DC Department of Health, which has set goals to “Promote” testing, “Prevent” transmission, and “Protect” those individuals already infected through increased access to antiretroviral therapy.10 In November 2007, we initiated the first inpatient HIV-POC screening program within a VA hospital setting. During 2000-2007, the mean annual rate of HIV testing targeted to those at risk had been 4.25% of those patients receiving care at the VAMC-DC, with an HIV seropositivity rate of 3.4% among those tested.11 By offering routine voluntary screening to 4011 inpatients, our test acceptance rate increased to 23.8%, representing a rise of more than 5-fold. We documented an incidence of 1.2% of reactive results, which were all confirmed by Western blot assay. Following the CDC-recommended age range for testing of 13- to 64-year-old patients,6 our seropositivity rate was 1.6% among the 556 patients tested within this age group. Of all the patients tested, 99.9% of patients were informed of their results. All confirmed patients with HIV were linked to medical care in our Infectious Diseases Clinic.
Few hospitals in the United States have reported routine voluntary inpatient testing programs.12-15 One of the first voluntary HIV testing programs was implemented at Boston Medical Center in 1999,12 where the rate of HIV seropositivity with targeted testing in the 15 months before their study had been 14.3%. This study evaluated only medical inpatients and used conventional serologic testing. During their study, only 6.4% of 7356 hospitalized patients underwent testing and the rate of positive test results among those tested was 6.8%, which nearly doubled their yield of new HIV diagnoses. The authors acknowledged that their seropositivity rate would likely have fallen, if more patients had been screened; they did not discuss in detail the reason(s) for their low testing rate. This study relied on admitting house staff and attending physicians to offer testing and then to inform a counselor, who would consent the patients and draw the blood samples. These extra responsibilities imposed on busy physicians may have resulted in their low testing rates.
In a second study performed at a New York City hospital in 2005,13 420 consecutive patients, hospitalized on a general medicine ward, were offered testing. Similar to our study, physicians offered and performed OraQuick rapid HIV testing using fingerstick whole blood only on weekdays; Western blot confirmation was done on all positive screening results. There was a 24% acceptance rate, which is comparable to our study. Three patients had initial reactive screening results that were all confirmed by Western blot, yielding a seropositivity rate of 0.7%.
In October 2006, Howard University Hospital (HUH) in Washington, DC, implemented a hospital-wide HIV screening program in the emergency department, in a designated outpatient testing room and on the inpatient units using rapid oral fluid-based testing.14 In contrast to prior studies, the testing staff included not only physicians but also dentists and nurses. During the 8-month period, 9817 patients were approached and 5642 patients consented to testing, representing a 57.5% patient acceptance rate. However, only 37.4% of the 139 patients with reactive rapid HIV tests had Western blot confirmation because there was no on-site confirmatory test available during the first 6 months of screening. Patients with reactive screening test results were contacted to return for Western blot testing, but many patients could not be located; they reported an initial confirmation rate of 30%. During the last 2 months of their study, Western blot confirmatory tests were immediately available for positive results and this raised their confirmation rate to 76.5%. These experiences from HUH highlight the importance of prompt confirmation of patients' positive screening results. During our study, we were able to achieve a 100% confirmation rate because we were able to use blood samples already in the laboratory for Western blot assays and to provide linkage for patients to receive these confirmatory results in a timely manner.
In the HUH study, only 38 of the 52 patients with reactive screening tests who received Western blot assays were confirmed to have HIV infection,14 indicating false-positive rate of 27% and highlighting the lower specificity (73%) reported for rapid testing with oral fluid15,16 compared with whole blood.17,18 For our inpatient HIV-POC testing program, we had no false-positive results (100% specificity) with rapid testing performed on 611 whole blood samples and on 213 oral fluid samples.
Although our HIV-POC screening program allowed us to offer testing to a large number of inpatients on 2 services, our staff did not offer rapid screening to 3504 inpatients on the 3 wards in our study. This group represented 39% of medical and 73% of mental health inpatients. Whereas we approached medical ward inpatients at the bedside on weekdays, we provided testing after weekly HIV education sessions for mental health inpatients as coordinated with our mental health providers. These pragmatic methods for the 2 services likely contributed to differences in our testing rates and seropositivity rates. In addition, the number of patients outside the HIV-POC program who were cogent to provide consent for HIV testing is unknown. However, the conventional HIV antibody testing rate using phlebotomized blood for these 3504 patients was 3.8% during our study period; this rate is comparable to our annual testing rates of 3.8%-4.9% during 2000-2007, when testing was primarily targeted to those with risk behaviors.11 As we did not perform screening on weekends and holidays, we may have missed patients who were discharged during those days, adding other differences in patient selection bias. These discharged patients may have had milder disease severity, fewer medical comorbidities, and better medical outcomes compared with inpatients approached in our HIV-POC screening.
Our overall acceptance rate for HIV-POC testing was 24%, but there was considerable variation in the acceptance rates between medical (20%) inpatients at the bedside and mental health (48%) inpatients after weekly group sessions. This may suggest that acutely ill medical patients may be less likely to address issues that they perceive may not be immediately relevant to their hospitalization, whereas mental health inpatients attending group education sessions may be more prone to accept HIV screening in the context of routine health maintenance.
Low acceptance rates for testing remain a major hurdle in addressing the HIV epidemic. During our screening program, VA Public Law 100-322 Section 124 subpar. 9c (1988) required documented written informed consent with both pretest and posttest counseling for HIV testing. It is unclear how much this requirement may have affected our acceptance and testing rates. This law was repealed in October 2008, and since August 2009, VA has adopted a policy for routine HIV screening of all Veterans. Patients must be provided with written educational materials about HIV testing and give verbal consent before testing. This policy for routine testing that is in accordance with CDC recommendations6 and American College of Physicians guidance7 is expected to increase our testing rates.
There are several reasons to adopt routine HIV-POC testing for all inpatients. First, routine rapid HIV screening on admission has been shown to be beneficial for hospitals in shortening lengths of inpatient stays.19 Of 103 newly diagnosed HIV-infected patients admitted to Cook County Hospital, 47% underwent rapid screening in the emergency room followed by Western blot confirmation, whereas the remaining inpatients were diagnosed through traditional testing. The length of stay for those with rapid testing was significantly shortened by 5.4 days compared with the 53% who had conventional HIV testing. This reduced length of stay was attributed to more efficient care because patients who tested positive were transferred to an HIV inpatient ward where they were managed by staff experienced in streamlining tests/services and coordinating HIV care. Even though many hospitals do not have dedicated HIV wards, earlier knowledge of a patient's HIV status should allow for earlier directed therapy. Shortening lengths of inpatient stays would dramatically decrease hospitalization costs, especially in areas with high HIV prevalence.
Second, patients are more likely to accept rapid HIV testing and should, as a consequence, be more likely to receive their test results. Our program achieved a 99.9% result notification rate. A survey of emergency room patients in Rhode Island found that 65.1% favored having a rapid HIV test instead of a conventional HIV test and that 94.6% preferred to have test results within 1 hour.20 A randomized study among individuals with high-risk behaviors showed that there was a statistically significant increased rate of HIV testing and receipt of test results when patients were offered rapid blood or oral fluid testing compared with traditional serum testing.21 Because individuals who are tested with reactive rapid HIV tests are more likely to receive notification of their test results, they can be more successfully linked to the appropriate medical care before discharge. Earlier linkage to care would allow timely initiation of antiretroviral therapy without progression to AIDS. Earlier identification of HIV infection and earlier initiation treatment at 350 cells per cubic millimeter rather than 175 cells cubic millimeter has also been estimated to result in a survival advantage of about 1.5 years.22
In addition, these patients can be counseled about adopting safer sexual behaviors, thereby reducing the risk for further HIV transmission.23 A one-time HIV screening program has been estimated to reduce by 21% the annual transmission rate through changes in high-risk behaviors and decreased viral loads among those who started antiretroviral therapy.22
All patients diagnosed with HIV infection were provided linkage to our Infectious Diseases Clinic, and 60% initiated antiretroviral therapy. Our overall rate of new HIV diagnoses was 0.8%. This rate is lower than the 3.2% HIV prevalence reported in the DC in 2009.10 However, the HIV rate among our inpatient population was comparable to the inpatient prevalence rates of 0.8%-6.9% documented from blinded anonymous serum samples from 6 other VA health care sites.24 We did not perform any blinded testing on those patients who declined HIV testing. Therefore, the prevalence of HIV infection is not definitively established for our inpatient population.
There are a number of potential reasons for our lower than expected rate of reactive tests. First, the patient population for the VAMC-DC includes surrounding areas in Maryland, Virginia, and West Virginia, which have lower HIV prevalence rates than Washington, DC. Second, many patients with high-risk behaviors may decline testing, as they may not perceive themselves at risk. A study from a New York City hospital evaluated patient acceptance of routine voluntary HIV testing using a self-administered survey. Of those completing the survey, 69% stated that they had no risk factors for HIV, despite 53% of respondents reporting 1 or more specific clinical or behavioral HIV-related risk factors.13 Among those with 1 or more risk factors, only 56% had reported prior HIV testing.13 These authors concluded that “most patients do not accurately self-identify risk,” highlighting the need for routine HIV screening as part of medical care. Among HIV-infected patients in care at VAMC-DC, 41.5% disclosed no HIV risk factors.11 During our 15-month study period, only 6.7% patients declined testing due to absence of risk factors. However, the actual number may have been much higher because 53.3% stated that they were “not interested” without giving further explanation.
Third, 82% patients tested at VAMC-DC were 50 years or older; 268 patients were 65 years or older, which was above the CDC-recommended age range for testing. Among the patients with confirmed HIV in our HIV-POC program, 57% were 50 years or older. This rate was much higher than the rate of 10%-15% reported nationally25 and the rate of 12% in Washington, DC,10 for the newly diagnosed HIV/AIDS cases among persons 50 years and older. Based on the 2006 national survey, the largest age group at diagnosis was the 35- to 44-year-old age group (32%) followed by the 25- to 34-year-old age group.26 Within Washington, DC, the highest rate of HIV diagnosis was 35.7% among the 30- to 39-year-old age group.10 Although the majority of patients whom we tested were older than 50 years, testing in our Veteran population remains cost effective in DC. This has been supported by the findings of Sanders et al27 that screening can be cost effective even for people aged 65-74 who do not have a partner at risk for HIV infection, if the prevalence of HIV in the community approaches 0.5%.
We have demonstrated how expanding HIV-POC testing among our hospitalized patients enhanced their acceptance for HIV screening, identified previously undiagnosed infection, and improved linkage to care for those with HIV infection. Hurdles remain in optimizing the HIV screening process, which will have the greatest impact on enhancing risk reduction education, improving early HIV diagnosis, facilitating antiretroviral treatment, and reducing HIV transmission. We strongly advocate for continued voluntary testing using rapid HIV-POC screening for inpatients regardless of risk factors or age as the first line in the goal of achieving routine universal testing as a standard of medical care.
The authors thank Robert E. Williamson, PhD, for his assistance with clinical database extractions and Maggie Czarnogorski, MD, for her careful review of this article.
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