AIDS PATIENT CARE and STDs Volume 19, Number 4, 2005 Mary Ann Liebert, Inc. Rapid HIV Testing of Clients of a Mobile STD/HIV Clinic THOMAS S. LIANG, M.P.H., 1 EMILY ERBELDING, M.D., M.P.H., 3 CLAUDE A. JACOB, M.P.H., 2 HOWARD WICKER, 1 CAROL CHRISTMYER, 4 STERLING BRUNSON, 4 DAMARIS RICHARDSON, 4 and JONATHAN M. ELLEN, M.D. 1 ABSTRACT HIV rapid testing may enhance the effectiveness of a mobile HIV/sexually transmitted disease (STD) screening clinic in at-risk populations who normally do not seek care. Our goal was to determine the usability and post test counseling rates of rapid HIV testing services for clients tested on a mobile clinic. HIV Oraquick rapid HIV-1 testing (OraSure Technologies, Inc., Bethlehem, PA) (blood) was offered to clients seeking HIV/STI counseling and testing services from the street at predetermined locations in areas of high STD morbidity, drug use, and commercial sex work. Rapid test results were available on the same day at the van within 10 minutes. Disease intervention specialists (DIS) attempted to locate and counsel positive clients who did not stay for results. By comparison, when offered at the same time, 64.5% of clients preferred Oraquick to traditional serologic testing. The post test counseling rate for clients tested for Oraquick was 89% for infected and 93% for uninfected. By comparison, 11% of infected clients and 40% of uninfected clients tested for traditional test were post test counseled. Clients who tested for the traditional enzyme immunoassay (EIA) test were told to return to the van in 14 days for results and post test counseling. In the adjusted model, we also found statistically significant differences comparing clients who choose Oraquick to traditional serologic tests. These data suggest that rapid HIV testing services may enhance the effectiveness of mobile STD/HIV clinics. INTRODUCTION THE UJIMA PROJECT is a STD/HIV mobile screening clinic aimed at identifying HIV and STI-infected individuals and link them in care and prevention. It is operated by the Baltimore City Health Department (BCHD), Johns Hopkins University, and the Maryland AIDS Administration, Maryland Department of Health and Mental Hygiene (DHMH) as part of the Centers for Disease Control and Prevention (CDC) sponsored Prevention for HIV Infected Persons Project (PHIPP). Staffed with a nurse practitioner, phlebotomist, community health educators, and outreach workers, the mobile van is stationed at predetermined loca- 1 Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland. 2 Division of Health Promotion and Disease Prevention, Baltimore City Health Department, Baltimore, Maryland. 3 Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. 4 AIDS Administration, Maryland Department of Health and Mental Hygiene, Baltimore, Maryland. 253
254 tions in areas of high STD morbidity, drug use, and commercial sex work. The van operates during normal business hours during the week and occasionally in the evening or weekend at health fairs. In Baltimore City, the majority of exposures to HIV were via injection drug use, heterosexual sex, and men who have sex with men. Among the HIV-infected population in Baltimore, the majority is African American (89.8%) and male (59.8%). There are also many infected individuals who do not know their serostatus and are not linked in any prevention or medical services. Health departments are tasked with identifying individuals at high risk for transmitting HIV (e.g., injection drug use and commercial sex work), enrolling them in medical care, and providing services designed to reduce their HIV-related risk behaviors. Identification of HIV-infected individuals and post test counseling (PTC) are pivotal steps in preventing and reducing HIV transmission, particularly in outreach settings. However, barriers exist in counseling and testing and referral (CTR) programs designed for individuals who do not seek care. In our previous study, we found that many of the HIVinfected individuals who received traditional serologic testing on our mobile HIV/STI screening clinic were not receiving post test counseled. 1 Recent studies show that rapid testing may enhance the effectiveness of nonstandard testing programs. 2 6 Rapid tests are less invasive and results are available in less than 20 minutes. The Food and Drug Administration (FDA) recently approved a third rapid HIV test: Oraquick Rapid HIV-1 antibody test (OraSure Technologies, Inc., Bethlehem, PA). 7,8 Using blood obtained from finger stick, Oraquick has a sensitivity of 99.6% (98.5% 99.9%) and a specificity of 100% (99.7 100%). The other two approved tests include Reveal Rapid HIV-1 antibody test (blood) (MedMira Laboratories, Halifax, Nova Scotia) and Single Use Diagnostic System (SUDS) HIV-1 rapid test (blood), the latter of which has recently been taken off the market. Based on clinical studies, rapid tests are comparable in results and are more cost efficient than traditional EIA HIV tests. Faster results from rapid tests can increase the number of individuals who get tested but would otherwise not return for results and know of their serostatus. Failure to return prevents CTR programs from administering post test counseling, which is designed to explain test results, promote safe sex and condom use practices, and provide a referral to a health clinic if infected. We introduced Oraquick rapid HIV testing services on the UJIMA mobile clinic. The objectives of this paper are (1) to determine the usability of rapid HIV testing services, (2) examine the differences in risk factors between those who chose rapid and traditional tests, and (3) to determine and compare post test counseling rates for HIV-infected and uninfected individuals tested for rapid and traditional tests on our STD/HIV mobile screening. MATERIALS AND METHODS The UJIMA demonstration project and these analyses were exempt from human subjects considerations by the BCHD and DHMH institutional review boards. Study participants were recruited from the street by outreach workers or walked into the mobile clinic on their own. HIV Testing Demographic characteristics, clinical history, and personal risk behaviors were collected from clients seeking HIV/STI services at the time of testing by trained health educators. Participants received pretest HIV counseling and the choice of a traditional test serum-based HIV-1 rlav enzyme immunoassay test (EIA) (BIO-RAD, Hercules, CA) or Oraquick rapid HIV-1 test. EIA and Oraquick rapid HIV tests were offered from May 2003 to February 2004. Clients were notified of the availability of test results before making their selection. All reactive results were confirmed by Western blot (WB) (BIO-RAD). Post test counseling LIANG ET AL. Clients who were tested with a traditional test were told to return to the van at least 14 days later for their test results. Oraquick results were ready within 10 minutes. Clients with a reactive
RAPID HIV TESTING 255 TABLE 1. BASELINE DEMOGRAPHICS Traditional Oraquick a Characteristic n 156 n 284 Mean age, years 34.7 36.7 Female 63 (40.4) 105 (37.1) African American 118 (75.6) 246 (86.9) Ever treated for an STD 63 (39.1) 114 (40.3) Positive STD diagnosis at visit 9 (5.9) 27 (10.4) Drug treatment in last 3 months 54 (34.6) 71 (25.1) Commercial sex work in last 3 months 17 (10.9) 30 (10.6) Drugs Never used 46 (29.5) 107 (37.8) Used noninjection in last 3 months ago 46 (29.5) 90 (31.8) Used injection in last 3 months ago 64 (41.0) 86 (30.4) a OraSure Technologies, Inc., Bethlehem, PA. STD, sexually transmitted disease. Oraquick test result were post test counseled as preliminary positive and referred to the STD clinic for confirmatory testing. A disease intervention specialist (DIS) attempted to notify and provide post-test counseling (PTC) services to all HIV-infected clients as soon as test results were available (approximately 7 10 days later). Using collected personal information obtained at the van or from the local health clinic, the DIS tried to contact and locate infected clients for 28 days after the date of the test result. Days to PTC was defined as the time in days between the test date and the subsequent visit to the van/health clinic or the time between the test date and the date notified by DIS. Analysis Data was analyzed using Stata 7.0 (Stata Corp., College Station, TX). We compared characteristics of clients tested for HIV using simple logistic regression, computing unadjusted odds ratio and 95% confidence intervals. RESULTS During the study period, a total of 461 firsttime clients were seen and of those, 439 (95%) accepted confidential HIV testing services. Of those tested for HIV, the client age ranged from 13 to 70 with an average age of 36.0 years old. The majority were African American (82.9%) and male (61.7%). A total of 18 HIV-positive individuals were identified and the overall HIV infection rate was 4.1%. Table 1 lists demographic, clinical, and behavioral factors for clients tested by HIV test. Almost two thirds (64.5%) of clients preferred Oraquick to a traditional test. In the adjusted TABLE 2. COMPARISON OF CLIENTS WHO CHOSE RAPID VERSUS TRADITIONAL TESTING Characteristic Unadjusted Adjusted Age 1.02 (1.00 1.04) 1.02 (0.99 1.04) Female 0.87 (0.58 1.53) 0.78 (0.51 1.18) African American 2.14 (1.29 3.54) a 1.91 (1.11 3.28) a Ever treated for an STD 1.05 (0.70 1.57) Positive STD diagnosis at visit 1.85 (0.85 4.05) Drug treatment in last 3 months 0.61 (0.40 0.93) a 0.58 (0.37 0.92) a Commercial sex work in last 3 months 0.93 (0.50 1.76) Drugs Never used Reference Reference Used noninjection in 3 months ago 0.83 (0.51 1.37) 0.93 (0.55 1.58) Used injection in 3 months ago 0.58 (0.36 0.94) a 0.67 (0.40 1.10) a p value 0.05. STD, sexually transmitted disease.
256 model, we found statistically significant differences between those who choose Oraquick to traditional test. Clients who are African American were more likely to choose Oraquick to a traditional test; those who had been in drug treatment in the past three months were less likely (Table 2). Of the 429 HIV-uninfected clients, 314 (73%) received PTC and 9 of the 18 (50%) HIV-positive clients received PTC. Table 3 lists PTC by test for uninfected and infected clients. Of the 284 clients tested for Oraquick, 8 of 9 positive clients (89%) and 255 of 275 (93%) negative clients were post test counseled at the same visit to the mobile clinic. By comparison, 11% of infected and 40% of uninfected clients receiving a traditional test were post test counseled. The one infected client who received PTC returned to the mobile clinic for results. Among the uninfected, 59 of 147 (40%) were post test counseled for their results. DISCUSSION Our analysis suggests that rapid testing is highly feasible and effective for nonstandard programs such as mobile health clinics. By comparison, when offered at the same time, 64.5% of clients preferred Oraquick to a traditional test. Clients who are African American were more likely to choose Oraquick over a traditional test, while those who had been in drug treatment in the past 3 months were less likely LIANG ET AL. to do so. Although clients were not surveyed to determine the reason for their test choice, Oraquick was likely more appealing to clients with less social stability, including those who are unwilling to return to the van 2 weeks later for test results. Among clients tested using Oraquick, 89% of clients with reactive test results were post test counseled during the same visit, while 93% of uninfected clients were counseled and notified of their result (90% at same visit). These rates are substantially higher than those for traditional testing. The Centers of Disease Control (CDC) reported national PTC rates in 1998 for HIV CTS publicly funded sites of 52% overall and 62.5% for HIV-infected individuals (9). In a previous study, we reported post test counseling rates of 43% of HIV-uninfected and 66% of HIV-infected clients on our mobile STD/HIV screening clinic offering traditional testing, in spite of DIS efforts to notify and refer HIV-infected individuals tested on our mobile STD/HIV screening clinic. These data support the use of rapid HIV testing in nontraditional outreach programs such as mobile HIV/STD clinics. The advantages observed with rapid testing such as fast and reliable results and easy storage contribute to the higher preference and post test counseling rates observed among clients tested on the mobile HIV/STD clinic. However, rapid tests are not without their limitations including their impact on clinic flow and need for confirmation. TABLE 3. HIV POST TEST COUNSELING RATES Test result Positive Negative Clinic Clinic Clinic notification Clinic notification notification (different DIS notification (different Test Number (same day) day) notification Total % Number (same day) day) Total % Oraquick a 9 8 0 0 8 89% 275 246 9 255 93% Traditional 9 N/A 1 0 1 11% 147 N/A 59 59 40% test Total 18 8 1 0 9 50% 429 246 68 314 73% a OvaSure Technologies, Inc., Bethlehem, PA. DIS, disease intervention specialists
RAPID HIV TESTING 257 ACKNOWLEDGMENTS The authors thank the UJIMA staff for their contribution to this study, including Joshua Michaud, Eka Gvasalia, and Michelle Chung for technical support. This project was supported by a grant from the Centers for Disease Control and Prevention (U62/CCU302047), Department of Health and Human Services (DHHS). REFERENCES 1. Ellen JM, Liang TS, Jacob CA, Erbelding E, Christmyer C. Post HIV test counseling of clients of a mobile STD/HIV clinic. Int J STD AIDS (2004;15:728 731). 2. Ekwueme DU, Pinkerton SD, Holtgrave DR, Branson BM. Cost comparison of three HIV counseling and testing technologies. Am J Prev Med 2003;25: 112 121. 3. Burrage J Jr. HIV rapid tests: Progress, perspective, and future directions. Clin J Oncol Nurs 2003;7: 207 208. 4. Keenan PA, Keenan JM. Rapid HIV testing in urban outreach: a Strategy for improving posttest counseling rates. AIDS Educ Prev 2001;13:541 550. 5. Peralta L, Constantine N, Griffin Deeds B, Martin L, Ghalib K. Evaluation of youth preferences for rapid and innovative human immunodeficiency virus antibody tests. Arch Pediatr Adolesc Med 2001;155:838 843. 6. Kassler WJ, Dillon BA, Haley C, Jones WK, Goldman A. On-site, rapid HIV testing with same-day results and counseling. AIDS 1997;11:1045 1051. 7. Centers for Disease Control and Prevention. Approval of a new rapid test for HIV antibody. JAMA 2002;288:2960. 8. Centers for Disease Control and Prevention. Approval of a new rapid test for HIV antibody. MMWR Morb Mortal Wkly Rep 2002;51:1051 1052. 9. CDC Annual Report of 1997 and 1998. HIV Counseling and Testing in Publicly Funded Sites. Annual Report 1997 and 1998. Atlanta: CDC, 2001. Address reprint requests to: Jonathan M. Ellen Johns Hopkins Hospital, Park 307 600 North Wolfe Street Baltimore, MD 21287 E-mail: jellen@jhmi.edu