1 ASSESSING POINT OF CARE HIV TESTING AS PART OF HIV SCREENING AT By: Lydia Gindy University of Manitoba Home for the Summer 2016 Thompson, MB Supervisor: Dr. Michael Isaac
2 Introduction It is estimated that approximately one quarter of Canadians living with HIV are unaware of their HIV status. Moreover, it is estimated that the province of Manitoba has the third highest HIV diagnosis rate in Canada 1. One of the methods used to address the HIV issue in Canada in order to improve HIV testing efficiency and accessibility is Rapid HIV Point-of-Care Testing (POCT). Although Rapid HIV POCT has been available in Canada since 2005, this method of testing is not yet available in all health care settings. Rapid Point of care (POC) HIV testing is a screening test that specifically tests for HIV antibodies and can provide results within minutes. One type of POC HIV test has been licensed for use in Canadian health care settings and is called the INSTI HIV-1/HIV-2 antibody test. This test is a manual, and visually read immunoassay that qualitatively detects HIV antibodies in the blood via a finger-prick. This is in contrast to standard HIV serology testing; both the Rapid POCT and standard serological testing have similar sensitivity and specificity measures (Sensitivity, Specificity > 99%) and both tests can detect antibodies approximately three to four weeks after initial HIV infection 2. The primary difference between POC testing and standard serologic testing is that standard HIV testing requires a laboratory-based method, which is a two-step protocol that combines screening (i.e., enzyme-linked immunoassay, EIA) and confirmatory (i.e., Western Blot) testing. The twostep protocol for standard HIV testing will produce results within a week of the blood draw while the HIV POCT has instant results. Additionally, HIV POCT is non-conclusive and once reactive, requires additional confirmation using serological testing 3. Thompson is a city in Northern Manitoba with a population of 13,123. Thompson provides many health services and has a general hospital with obstetrical services. In contrast, the Pas and Flin Flon, also both in Northern Manitoba, have populations of 5,513 with the latter having a population of 5,592 4. At Thompson General Hospital, Rapid Point of Care HIV testing occurs at the time of delivery when HIV status of the mother is unknown, initial prenatal STI screening was incomplete, or if prenatal records are inadequate. In contrast, the Pas, and Flin Flon do not currently conduct Rapid Point of care HIV testing during the time of delivery despite having obstetrical health services. The aim of this project is to assess current North American literature and data surrounding rapid HIV POC testing and assess data collected from a questionnaire surveying staff at Thompson General Hospital to inform the decision on whether or not Rapid POC HIV testing should be implemented in the Pas and Flin Flon, Manitoba. Methods Two separate methods were used to assess Point of Care HIV testing as part of HIV screening at delivery in the Northern Health Region; the first being literature review and second being a selfadministered questionnaire.
3 Information collected for review assessed databases that included: community health assessment data for the Northern Health Region, Pub Med Central to review POC testing data in North American research, and the Cadham Laboratory database. When using Pub Med Central, the search strategy employed used a broad search using the terms Rapid HIV POCT. When searching for specific articles in PubMed Central, filters that were used found articles that targeted POCT HIV specifically in women, articles that conducted POCT testing in North American hospitals, or articles that conducted POCT at the time of labour and delivery. The self-administered questionnaire used collected data from 14 nurses at Thompson General Hospital trained to conduct Rapid POC testing. For each item, a typical 5-point Likert scale ranging from strongly disagree to strongly agree was used. The statements of the questionnaire were: 1. POC testing is comfortable/easy to administer 2. There was adequate training on how to conduct the test 3. I feel comfortable interpreting the results of the test 4. Patients seem willing to take the test 5. This test should be implemented at labour and delivery in Flin Flon & the Pas, Manitoba All survey test results were taken into consideration with the exception of health care providers who were trained in conducting the Rapid HIV POC test but have not yet performed it. Figure 1 illustrates the questionnaire used for this study. Figure 1: Thompson General Hospital Rapid HIV Point of Care Sample Survey
4 Results Acceptability of Rapid HIV Point of Care Testing An initiative created by the World Health Organization for Sexually Transmitted Diseases Diagnostics developed criteria called the ASSURED criteria that helps decide if tests are adequate enough to address disease control needs: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. This criteria serves as a guideline to ensure that POC diagnostics are affordable by those at risk, both sensitive and specific, simple to perform by administers, enabling treatment at first visit, not requiring refrigerated storage, easily collected, and not requiring complex equipment 5. Rapid HIV point of care testing shows to be comparable to standard HIV testing in sensitivity and specificity. Moreover, evidence from two-quasi experimental and two crosssectional studies demonstrate that HIV rapid testing can be done easily and conveniently in multiple different areas. Rapid HIV testing boasts immediate results, in contrast to standard HIV testing which can take a week or more 2. Other factors to consider besides the ASSURED criteria are preference of tests, the accessibility of information once there are results, affordability, linkage to care, and satisfaction with the test 2. A recent study conducted in a primary care clinic found that 81% of the women surveyed preferred rapid testing to standard testing 6. Moreover, a systematic review found that participants who received rapid testing were almost two times more likely to receive their results than participants who received standard testing 7. Even if more individuals are receiving rapid testing results compared to standard testing, rapid point of care testing should be assessed for affordability. Since each rapid test kit is an additional cost to the health care system, cost-effectiveness must be taken into consideration. Since standard testing requires follow up after test results return while rapid testing results in immediate results, rapid testing is argued to be more cost effective if one takes retrieval of results into account 8. Linkage to care after HIV results should also be considered in deciding whether or not rapid testing is essential. In a cross-sectional study conducted in an emergency department in Winnipeg, out of 501 adults, a total of seven individuals tested reactive with the POC test, all later confirmed by the serological testing. All of the individuals that tested positive were linked with HIV care 9. Another study in the city of Vancouver shows linkage to care rates being 89% 2. Satisfaction with a test is also an important component of deciding on the acceptability of a test. In the study conduced in Winnipeg, out of 501 adults, 96% of the participants reported satisfaction with the test 9. While there are benefits that come from using rapid HIV screening at point of care, there are concerns that must be considered. A concern about Rapid HIV POCT is due to false positive
5 results. If positive results occur during HIV POC testing, patients may be subjected to psychological and emotional distress while awaiting results of confirmatory serological testing. Moreover, in low-prevalence areas, there can be an even greater increase in false positive results that can result in unnecessary interventions in order to prevent transmission during labour using sub-optimal test results. Although there is the convenience of rapid POCT, accessibility to adequate pre-test counseling while testing, and support services after positive test results may not be fully accessible to patients in certain communities 2. While Rapid POC testing is able to fulfill the ASSURED criteria and while current scientific literature suggest that rapid point-of-care testing improves outcomes relative to serological testing, concerns regarding POC testing should be still taken into consideration. It is also important to note that current scientific literature surrounding the ASSURED criteria have been collected outside of the obstetrical ward context. Rapid HIV Point of Care testing in Obstetrical Units Rapid HIV Point of Care testing in obstetrical units is done in settings where antenatal care is inadequate. This implies that standard serological HIV testing that was completed or should have been completed prenatally is not available at the time of labor and delivery. Therefore, rapid HIV POCT at labor and delivery may be the last opportunity to prevent mother-to-child HIV transmission and to begin antiretroviral prophylaxis 10. In 2003, an initiative created by CDC for HIV prevention worked on two goals: making HIV testing as routine as other diagnostic and screening tests, and reducing perinatal transmission of HIV by testing all pregnant women. Due to these preventative measures, results suggest a decrease in incidence of pediatric HIV when routine HIV testing during pregnancy began. In the United States, perinatal transmission rates were lowered to <2% with routine HIV testing in combination with prophylactic administration of antiretroviral drugs, scheduled cesareans when indicated, as well as breast-feeding avoidance if infected 11. The Canadian Perinatal Surveillance Program conducted by the Public Health Agency of Canada has found that the number of infants that were perinatally exposed to HIV has increased over time. However, the proportion of infants confirmed to be HIV-infected has decreased from over 25% before the initiation of antiretroviral therapy in 1996 to less than 1% in 2014 12. There has been a marked increase in the use of rapid HIV testing in labour wards in the United States but despite these outcomes, Canada still only has a few hospitals with labour and delivery units that provide rapid HIV testing 11. An Alberta program attempted to determine if Rapid HIV point of Care testing was successful in finding HIV cases through testing at labour and delivery. This Alberta pilot rapid HIV testing program was implemented in five acute care hospitals that studied 1737 patients, spanning from 2007-2009. Results showed that although the number one reason patients were being tested for HIV was due to unknown HIV status near term, the number of reactive POC test and confirmed
6 positive HIV status in this population was zero. Instead, the demographic that had the most reactive POC testing with confirmed positive HIV status were those from the study that were acutely ill at admission 13. Another study that looked at testing at labour and delivery was the Mother-Infant Rapid Intervention at Delivery (MIRIAD) study; this study was a large, prospective, multicenter American project designed to evaluate the feasibility, acceptability, and accuracy of rapid HIV testing during labor conducted from 2001-2005. MIRIAD included women who had undocumented HIV status during their current pregnancy. Of 12,481 eligible women, 74% were approached for participation and 85.5% of those approached accepted rapid HIV testing. Among 7753 women tested, MIRIAD identified 52 (0.7%) HIV-infected women 14. Rapid Point of Care testing in the Northern Health Regional Authority The Community Health Assessment (CHA) of the Northern Regional Health Authority last reported in 2014 about where the Northern Regional Health Authority stands in regards to key health indicators of the area. As part of the assessment, adequate prenatal care was examined; the number of healthcare professional visits determines adequate prenatal care during the prenatal period. CHA reports that result show that between 2007-2009, the proportion of new mothers who had inadequate prenatal care was 36.4%, above the provincial average of 12.3%. This is important because inadequate prenatal care can limit mothers from receiving HIV serology testing during their initial prenatal visits. Additionally, the Community Health Assessment shows that in the Northern Regional Health area, the HIV rate is 5.4 new laboratory-confirmed infections per 100,000 per population per year, which is slightly lower than the Manitoba average of 5.8 per 100,000. By assessing the trend from 2010-2012, in Manitoba HIV rates have dropped overall but in the Northern Health region, HIV rates seem to be on a steady incline. This trend could be explained by an apparent shift in the reporting of rural cases, as more cases are identified from areas outside of Winnipeg than in previous years. Despite this, the 2014 surveillance report shows that only 2.7% of the new HIV cases in Manitoba were from the Northern Regional Health authority, according to the Public Health Agency of Canada 10. In communicating with the executive directors of the hospitals in Thompson, Flin Flon and the Pas, delivery data was provided. In Thompson, there is an average of 950 deliveries per year. Of those deliveries, there have been 41 HIV POC tests done on the labour and delivery ward since inception of the HIV POC test in Thompson. Forty of those tests were negative for HIV, one was found to be inconclusive but later turned out to be negative for HIV. The Pas averages 350 deliveries per year while Flin Flon averages 150 deliveries per year. Since Rapid HIV POC testing is not performed in the Pas and Thompson, STAT hepatitis B tests at the time of labour and delivery can be used as an estimate of the number of Rapid HIV POC test performed. This can be used as a measure since STAT hepatitis B tests can be conducted when patients have inadequate medical records surrounding hepatitis status. In contacting the Cadham Laboratory, there have been 3 STAT hepatitis B tests sent from the Pas since January 1, 2015. However, these tests are not confirmed to be tests performed during the prenatal period.
7 Flin Flon has had 23 STAT hepatitis B tests sent since January 1, 2015. Again, no information can be used to determine if these tests were sent during the labour and delivery period. Therefore, based on the limited information, results from Cadham laboratory cannot be used as a conclusive measure of Rapid HIV POC testing. The receptiveness of the Rapid HIV POC test staff was estimated by a survey conducted at Thompson General Hospital. Survey results are shown in Table 1. Table 1: Thompson General Hospital Rapid HIV Point of Care Test Survey Results Statements POC testing is comfortable/easy to administer There was adequate training on how to conduct the test I feel comfortable interpreting the results of the test Patients seem willing to take the test This test should be implemented at labour and delivery in Flin Flon & the Pas Strongly Agree Agree Neutral Disagree Strongly Disagree 10 (90.91%) 1 (9.09%) 6(54.55%) 5 (45.45%) 8 (72.73%) 3 (27.27%) 6 (54.55%) 4 (36.36%) 1 (9.09%) 10 (90.91%) 1(9.09%) Overall, survey results show that there was a trend towards having a strong receptiveness towards the Rapid POC test. Of the 14 nurses interviewed, only 11 nurses had actually administered the test. Of the 11 who had administered the test, most strongly agreed that the HIV POCT was comfortable and easy to administer. Approximately half either strongly agreed or agreed that there was adequate training on how to conduct the test. The majority strongly agreed that they felt comfortable interpreting the results of the test. With only one neutral answer, nurse responses either strongly agreed or agreed that the patients seemed willing to take the test. Of those who have previously administered the test, 90.91% strongly agreed that rapid POCT should be implemented in Flin Flon and the Pas at the time of labour and delivery. Limitations and future considerations: This study is limited by the limited information about specific HIV prevalence rates for Thompson, Flin Flon and the Pas. Moreover, lack of information about STAT hepatitis B tests makes it difficult to estimate the need for Rapid HIV POC testing in the Pas and Flin Flon,
8 Manitoba. Also, STAT hepatitis B testing may not be directly correlated with the lack of HIV testing prenatally for the mother in labour. Although Thompson, the Pas, and Flin Flon, are all communities in the Northern Health Region, demographics and health care needs in Thompson may not be reflective of those in Flin Flon and the Pas. The survey conducted in Thompson General Hospital is limited by the self-reporting nature of the surveyed participants, as well as the number of surveyed participants. Additionally, scientific literature assessed outside the context of obstetrical wards may not be reflective of Rapid POC testing performed primarily at the time of labour and delivery. If this study were to be continued it would be valuable to assess community-specific HIV prevalence rates, and assess patient records in all three communities to determine the rate of inadequate prenatal records; this information will better estimate the need for Rapid HIV POC testing at the time of labour and delivery. Conclusion/Recommendations Through data collection and surveying, it is possible to see that Rapid HIV POC testing is an acceptable test to perform with positive receptiveness from patients and nurses. However, there is still ethical concern surrounding the nature of the Rapid HIV POC testing that should be considered when deciding whether or not the test should be implemented in a specific community. Although there is minute incidence of new HIV cases in the Northern Health Region relative to the rest of Manitoba, and there have not yet been any positive HIV results from the Rapid POCT in Thompson to date, one cannot ignore the national HIV statistics and trends. Therefore, it would be worthwhile to collect community-specific information surrounding HIV health care needs in the Pas and Flin Flon, in order to determine the acceptability of implementing Rapid HIV POC testing in the obstetrical wards of these regions.
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