OR WAIT null SECS
In 2006, the CDC recommended “opt-out” routine HIV testing in all health care encounters for persons 13 to 64 years of age. While this recommendation has garnered some support, concerns about the feasibility of such routine testing in a busy office without disrupting patient care has persisted. We report the results of a pilot study to determine the feasibility of routine testing in a busy urban clinic.
An estimated 55,400 new HIV infections occur annually in the United States.1 Results of an analysis by the CDC indicate that in 2006, 40.4% of the population aged 18 to 64 years (an estimated 71.5 million persons) reported ever being tested for HIV infection, with 10.4% tested in the preceding 12 months.2,3 At the end of 2006, approximately 232,700 total persons, or 21%, infected with HIV were unaware of their infections.2,3
In September 2006, the CDC recommended HIV testing without the need for risk assessment and counseling (“opt-out”) in all health care settings. The objectives of the recommendation were to increase HIV screening of patients, foster earlier detection of HIV infection, link identified persons to clinical and prevention services, and reduce perinatal transmission of HIV in the United States.3
Studies have reported the cost-effectiveness and acceptance of universal screening compared with voluntary screening for HIV infection among pregnant women.4,5 Concerns have been raised about the feasibility, cost, and consequences of the CDC recommendation for a routine testing program in health care settings.6
Although Nevada has the nation’s 35th largest population, it ranks ninth in the nation for the rate of adolescents and adults living with AIDS.7 In 2006, 91% of persons living with HIV/AIDS in Nevada lived in Clark County.8 Nevada is one of the 15 states and the District of Columbia that has no special requirement for consent before HIV screening.9 Finally, Nevada is among the states that have a critical physician shortage.10 All of these factors make Nevada an excellent site for assessing the routine HIV testing recommendation.
The objectives of our study were to determine:
•The feasibility of a routine HIV screening program in a busy urban outpatient setting.
•The barriers to patient completion of HIV testing using whole blood assay.
Patients and Methods
This study was approved by the University Medical Center of Southern Nevada Institutional Review Board, with a waiver of written informed consent.
•Study setting. The outpatient clinic of a busy county hospital located in Las Vegas serves as a teaching facility for the University of Nevada School of Medicine residency programs in internal medicine and pediatrics. It has a dedicated continuity clinic used for residency training that is staffed by residents and faculty members from the school of medicine. The clinic provides care to approximately 6000 patients annually (24 to 28 patients per day). It was selected because of both its continuity nature and the supervised training of residents, factors that make slowing of clinic flow more evident and easily observed.
•Study design. From March 1, 2007, through June 30, 2007, patients were given written information delineating the 2006 CDC recommendations during registration and there was a brief discussion about the potential benefits and risks of HIV screening. They received a form describing the screening program, at the end of which was a box they could check to refuse (opt-out of) the recommended screening. When the box was not checked, the patient was assumed to have agreed to HIV screening. A medical assistant attached a test requisition form to charts with unchecked boxes, and a phlebotomist collected blood samples for HIV testing.
•Post-test follow-up. Blood samples were tested for HIV antibodies by the Health District laboratory. Because standard HIV enzyme-linked immunosorbent assay kits were used rather than rapid tests, patients were informed they could obtain test results in 1 of 2 ways. A card containing a code number identical to the one on the requisition form and a confidential telephone number operated by the Health District were given to patients. They could obtain their test results by calling the confidential number or through their physician at follow-up visits. Patients who had positive test results and called through the confidential telephone line were counseled and referred to their physicians for follow-up. Primary physicians discussed test results with all participating patients during follow-up visits. Clinic staff did not discuss the screening program further unless specifically asked by patients (Figure). All clinic staff members completed a 1-page questionnaire that assessed their perception of the program.
•Pre-study training. Physicians, nurses, medical assistants, and clerical staff members of the clinic participated in pre-study training. Although the clinic was open from 9 AM to 5 PM, forms were provided for patients only from 9 AM to 3 PM to allow investigators time to complete same-day chart review.
•Data collection. A team of pediatric and internal medicine residents, supervised by adult and pediatric infectious disease specialists, reviewed the charts of patients who attended the clinic on the same day. Data that included demographics (sex, ethnicity, age, and insurance), documented behavioral risk factors for HIV, and previous HIV screening results were collected.
•Data analysis. All descriptive and inferential statistics were calculated using SPSS version 15.0, SAS version 9.0, and NCSS/PASS 2004. Program feasibility was determined through a 1-page survey of the perception of the program by physicians, nurses, and clerical staff. Patients who did not sign the opt-out form where considered to have accepted the testing protocol.
During the 4-month study period, 742 patients were enrolled. The mean age was 49.9 years; 52% were female; and 44% were white, 26% were black, 24% were Hispanic, and 6% represented another race or ethnicity. Overall, 43% of patients (316/742) who received the information sheet accepted testing (Table). There were no statistically significant differences in acceptance rate by sex, ethnicity, pay source, or age range. A total of 41% of males (147/357) and 44% of females (169/385) accepted, as did 41% of whites (134/324), 41% of blacks (80/196), and 47% of Hispanics (83/178). The acceptance rate was 42% (169/400) among those who were insured, 44% (147/337) among the uninsured, 45% (142/316) among those 49 years and younger, and 41% (172/418) among those 50 years and older. Only 10% of patient medical records had documentation of the presence or absence of HIV medical or behavioral risk factors. Twenty-five completed surveys by clinic staff members were analyzed. When asked if a routine testing program was feasible without disrupting clinic flow, 100% (25/25) of the nursing and clinic staff surveyed agreed. A minority of the patients (1.8%) specifically asked the nursing or medical staff about the testing protocol, and none objected when further information was provided.
This study has several limitations. First, because we did not survey participants, we were unable to ascertain why patients accepted or did not accept routine testing. Although valuable information could have been obtained from their responses, consent would have been required to interview the patients or to have them fill out a questionnaire, which we considered a potential barrier to testing. Second, we used whole blood for HIV antibody testing instead of a rapid HIV test method. Although consideration was given to the use of rapid HIV testing, the county health department was unable to supply the kits and was concerned about test performance by non–laboratory-trained staff because this study was used to determine local point prevalence. Medical staff wanted to incorporate HIV testing into other routine testing, such as measuring cholesterol levels. Third, attempts to correlate testing acceptance with the known presence or absence of recorded risk factors for HIV acquisition was not feasible because the vast majority of medical records did not specifically address such factors as sexual orientation, sexual history, history of sexually transmitted infection, use of illicit drugs, transfusion history, or history of having had or having been tested for viral hepatitis.
The availability of treatment has dramatically improved survival rates for patients living with HIV infection.11 Early diagnosis and treatment are related to better outcome; the disease is more likely to progress to AIDS in persons whose HIV diagnosis is made late in the course of infection.12,13 Institution of routine HIV screening among pregnant women following evidenced-based interventions to reduce mother-to-child transmission of HIV resulted in a significant reduction in perinatal HIV transmission in the United States.14,15
The estimated incidence rate for HIV of 56,000 cases annually has been relatively stable over the past decade.16 This persistent level of infection and an estimated 20% to 25% of infected persons being unaware of their HIV status prompted the CDC to revise recommendations in 2006. The new recommendations sought to remove perceived barriers to HIV screening by advocating routine HIV testing for all persons aged 13 to 64 years as part of standard medical practice, similar to screening for other treatable conditions.3,4 The prevalence of undiagnosed HIV infection is high in socioeconomically disadvantaged patients, the same patients who commonly seek care in our county hospital.
Our study demonstrated that a routine HIV screening program can be implemented in a busy urban clinic with minimal interruption of workflow. Pre-study staff training and administration support was instrumental in the successful implementation of the screening program. The county health department provision of testing material removed the cost to our patients, which could have been a potential barrier to screening.
Our study implemented an actual testing practice and was able to determine the proportion of patients who agreed to be tested and who completed testing. Slightly fewer than 50% of patients who were offered routine testing accepted, but a significant number did not complete the test because they asked to go to a neighborhood laboratory on days when the phlebotomist was not available. Although we noticed this development early in the study, we chose not to alter the clinic routine of sending patients to outside laboratories when the phlebotomist was not available. The finding that most of these patients never went to the outside laboratory indicates that an on-site phlebotomy service may be essential for completion of testing among patients who agree to be tested.
The absence of statistical differences in age, sex, ethnicity, and insurance status among those who accepted testing was surprising. Previous research findings have indicated that independent of social-demographic characteristics, risk perception, and risk behaviors, persons covered by Medicaid were more likely to have voluntary HIV testing, suggesting that the type of health insurance may affect a person’s access to HIV counseling and testing services.17
The lack of documentation of potential risk factors in medical records further supports the recommendation for universal rather than specific risk–based screening in general primary care settings.
Routine, opt-out voluntary HIV testing is feasible in a busy urban clinic. An on-site phlebotomy service potentially improves completion of testing among patients who agree to such testing. A rapid HIV test method could offset the need for a phlebotomist and may increase the number of patients who complete the HIV test.
Author contributions: EEE and AG conceived and supervised the conduct of the study. NG, OE, EE, and JB collected and managed the data. EEE drafted the manuscript, and all authors contributed to its revision.
Funding and support: Supported in part by the Southern Nevada Health District, which provided HIV testing free of charge for participants.
Presented in part at the Pediatric Academic Societies meeting, May 5, 2008, Honolulu.
AcknowledgmentsThe authors are grateful to physicians, nurses, and clinic staff at the Lied Clinic, who implemented the screening program. We are grateful to Lawrence Sands, DO, and his team at the Southern Nevada Health District for their support with HIV testing.
Routine HIV Testing Study TeamDeepti Hemranjani, MD, Kanapa Kornsawad, MD, Ahmad Norman, MD, Cuong Nguye, MD, Jennifer Lising, MD, Sowmya Satya, MD.
References1. Hall HI, Song R, Rhodes P, et al; HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008;300:520-529.
2. Centers for Disease Control and Prevention. Persons tested for HIV-United States, 2006. MMWR. 2008;57:845-849.
3. Centers for Disease Control and Prevention. New Estimates of U.S. HIV Prevalence, 2006. October 2008. http://www.cdc.gov/hiv/topics/surveillance/resources/factsheets/pdf/prevalence.pdf. Accessed June 1, 2009.
4. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR. 2006;55(RR14):1-17.
5. FernÃ¡ndez MI, Wilson TE, Ethier KA, et al. Acceptance of HIV testing during prenatal care. Perinatal Guidelines Evaluation Project. Public Health Rep. 2000;115:460-468.
6. Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention’s recommendations for opt-out HIV testing. PLoS Med. 2007;4:e194.
7. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report, 2006. Vol. 18. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2008:1-55. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2006report/pdf/2006SurveillanceReport.pdf. Accessed June 9, 2009.
8. Nevada State Health Division. HIV/AIDS Surveillance Program. HIV/AIDS Fast Facts, 2006.http://health.nv.gov/PDFs/HIV_STD_TB/hivandaidsinnevada20002006.pdf. Accessed June 9, 2009.
9. National HIV/AIDS Clinicians’ Consultation Center. Nevada. In: Compendium of State HIV/AIDS Testing Laws. 2009. http://www.nccc.ucsf.edu/StateLaws/State%20Laws/Nevada.pdf. Accessed June 1, 2009.
10. Center for Workforce Studies. Recent Studies and Reports on Physician Shortages in the U.S. Washington, DC: Association of American Medical Colleges; 2009. http://www.aamc.org/workforce/recentworkforcestudies.pdf. Accessed June 8, 2009.
11. Palella FJ, Deloria-Knoll M, Chmiel JS, et al; HIV Outpatient Study Investigators. Survival benefit of initiating antiretroviral therapy in HIV-infected persons in different CD4+ cell strata. Ann Intern Med. 2003;138:620-626.
12. Centers for Disease Control and Prevention. Late versus early testing of HIV-16 sites, United States, 2000-2003. MMWR. 2003;52:581-586.
13. Sanders GD, Bayoumi AM, Sundaram V, et al. Cost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy. N Engl J Med. 2005;352:570-585.
14. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331:1173-1180.
15. Centers for Disease Control and Prevention. Achievements in public health. Reduction in perinatal transmission of HIV infection-United States, 1985-2005. MMWR. 2006;55:592-597.
16. Centers for Disease Control and Prevention. Increases in HIV diagnoses-29 states, 1999-2002. MMWR. 2003;52:1145-1148.
17. Tao G, Kassler WJ, Paterman TA; Association for Health Services Research Meeting. Health insurance status and HIV testing in the United States [abstract]. Abstr Book Assoc Health Serv Res Meet. 1998;15:54.