by Nicolas Sheon, Managing Desire Webmaster and HIV InSite Prevention Editor
Testing technologies are changing rapidly
and the current prevention infrastructure
must take advantage of new opportunitiesWorldwide it is estimated that roughly 90% of HIV infections remain undetected. The Centers for Disease Control and Prevention (CDC) estimate that one third of HIV positive people in the United States do not know their status. Although shrouded in controversy when it was first introduced in 1985, HIV antibody testing has become a routine medical procedure. There are now over ten thousand testing centers subsidized by the CDC, many of which offer free and anonymous testing. Many more people routinely test through their private physicians.
Promising new therapies have placed renewed attention on the need for creative methods to entice those at risk to learn their HIV status. In the US, more than half of people at risk have not been tested. The question is, how can testing become a more marketable commodity? Who is the "hard to reach population"? Those at risk or the test clinic staff?
Testing technologies are changing rapidly and the testing and counseling service infrastructure must take advantage of new opportunities if they can make testing more attractive to those who have not been tested. The key issues are access, privacy, and convenience. The new technologies address these issues in terms of lower cost, simpler collection methods, and rapid turn around time for results.
The Current System
The HIV antibody test currently used in most clinics and hospitals requires one or two tubes of blood to be drawn. A screening test, called the ELISA or EIA, is used first to screen out the negatives. When a reactive, or positive, sample is identified using the ELISA test, a confirmatory test, called the Western Blot, is used to rule out false positives. This two step process is highly accurate and is often available free of cost for the patients. However, it has the drawback of requiring a blood draw and a short face to face risk assessment which some people find invasive. After the blood is drawn, confirmed results may take anywhere from 4-14 days to be processed by the lab, requiring the patient to make a second visit to the clinic.
The existing system is clearly flawed because many at-risk people still avoid testing and nearly one third of HIV positives fail to return for their results. This system is also very expensive, since it requires trained counselors, blood drawers, laboratory technicians, and administrative staff in addition to the cost of the test itself.
Home Collection Kits
Ho me collection kits, available over the counter or via mail order were first approved for the US market in 1996. Home collection kits help to alleviate access issues and concerns over privacy and convenience associated with clinic-based testing. Like the traditional tests, home tests use blood, although patients prick their own finger and blot a piece of paper. The sample is then mailed to a lab and results are given over the phone several days later.
This testing systems costs $30 - $40 per test, however, because many people test with their partners, this means a eighty dollar investment paid completely by the patients. As long as free or nominal cost testing is still available from local public health clinic or through insurance, the high cost may deter many people from using home collection kits. Some have also questioned the quality of phone counseling and referrals provided with the home collection test. A person receiving a positive result via telephone can simply hang up and thereby deprive themselves of counseling and referral services. While, home collection kits offer privacy and convenience, their high cost ultimately fails to address the issue of access.
Other Testing Methods
HIV antibodies can be screened in fluids other than blood, with comparable accuracy. In 1996, an oral fluid collection test was approved for use by testing centers. This test, called Orasure, uses a toothbrush shaped probe that is inserted into the patient's mouth. The salty cotton probe absorbs oral-mucosal transudate from the cheek and gum. This is more accurate than testing saliva which has too few antibodies and may contain impurities.
Oral HIV testing is ideal for field-based or mobile testing by outreach workers, for instance at needle exchanges or when notifying partners of infected individuals. Non-blood tests may cost more than traditional tests, yet can result in lower staff costs since no blood drawers are needed, and the risk of accidental needle sticks is eliminated. However, like the blood tests, results must be disclosed during a separate visit since this test requires a the same turn around time as traditional methods.
This week, a testing system for urine was approved by the Food and Drug Administration. The approval of a complete urine testing system offers yet another alternative to blood. Urine-based diagnostic tests already exist for many conditions, including, prostate cancer, pregnancy, drug-abuse, chlamydia, and gonorrhea. Some clinics could use one urine sample for a battery of tests. This raises many concerns over informed consent for HIV testing at the workplace.
Another potential problem with urine tests is establishing a chain of custody for the sample. While blood and oral samples may be more invasive to collect, assuring the identity of a urine sample collected outside the lab could pose additional logistical problems.
Rapid Tests
Rapid screening tests have been in use in the developing world and Europe for several years. Rapid tests exist for blood, urine, and saliva. Until March 1998, testing guidelines developed by the CDC did not allow preliminary positive results to be given to testers since these unconformed results could be false positives. This meant that all clients typically have to wait up to two weeks for results which take one day to process.
Because so many people fail to return for their results at STD clinics, the CDC changed its long-standing policy against giving preliminary results in their guidelines for rapid testing released earlier this year. Rapid testing of blood is now approved for testing centers in the US, but with a major caveat. Because rapid tests have the potential for false positive results, this method is better suited to a clinic which services a high-risk population for which the rate of false positives will be much lower than in a low-risk population. Using rapid testing, negative clients, the vast majority, would test and receive their result in one visit. Positive clients would begiven preliminary positive results and be told to return for confirmatory results, usually the next week. False positives can be ruled out if two different brands of rapid screening tests are used. Unfortunately only one rapid test is currently approved for use in the US. One visit is clearly preferable to two visits, and this technology represents a significant step towards more convenient and accessible testing.
In the Near Future...
Two men exchange glances across a crowded dance club. They meet on the dance floor and then shimmy to the bar for a drink. Ready for action, they decide to leave for the privacy of a nearby apartment. But before leaving, one of them sheepishly glances at a candy jar sitting on the bar, filled with small foil packages. You are thinking, "thank goodness for a well placed stash of condoms," right? What if the foil packages contained easy to use rapid HIV tests? Whatever the test results and ethical issues inherent in this scenario, it is reasonable to assume that test results available within minutes would have a far greater effect on the men's behavior that night, than if they tested at a clinic and waited two weeks for the results.
Accurate, low cost, rapid tests are already in use outside the United States. Home testing kits (as opposed to home collection kits) are already available from fly by night vendors over the internet, but these tests are not approved by the FDA. The biomedical giant, Abbott, has recently acquired companies that produce rapid HIV tests and pregnancy tests, and appears poised to develop the next generation of rapid HIV tests for the US market by the millennium. These simple to use HIV tests are small strips of paper that would change color within minutes when antibodies are detected in whole blood or urine. Pending FDA approval, these new tests would eliminate the main obstacles to testing in the existing system: access to the clinic, laboratory turn around time, and fear of needle sticks.
If testing becomes an even more integral part of courtship rituals or even sexual foreplay between casual partners, prevention messages encouraging universal condom use may have to change their approach to account for the availability of "real-time" testing for sero-status. Bernard Bransen, a long time advocate for wider use of rapid HIV tests, believes that advances in testing technology and improved access will make condom-centered prevention messages less and less relevant. The assumption is that people will choose sero-concordant partners, take into account the 6-12 week antibody window period, and opt to have unprotected sex.
Implications for Prevention Programs
Clearly, both testing and treatment technologies have advanced more rapidly than prevention strategies. If over-the-counter home testing and testing by outreach workers using rapid tests plays a larger role in prevention strategies, we must rethink the role of clinic-based test counseling as well as prevention messages that fail to take into account the behavior of sero-concordant couples.
If these alternative testing modalities can help more people learn their sero-status, the CDC should consider ways to subsidize and distribute test kits among high-risk populations. Partnerships between test distributors and public health agencies should be forged so that new testing technologies are appropriately targeted and not misused to test people without consent or simply to profit from the "worried well." Legal protections for confidentiality and consent should also be revised to reflect the availability of home testing technologies. The potential abuses of the home testing must also be addressed through social marketing campaigns that explain the complex issues raised by rapid home tests.
Instead of a "one size fits all" message based on consistent condom use, complex strategies that take into account local community norms and individual needs within sero-concordant relationships should be encouraged. Most importantly, the effectiveness of testing modalities depends on their seamless integration with other services such as early clinical intervention, support services, and prevention counseling for both positives and high-risk negatives.
For more resources on testing technology see HIV InSite's Testing Technologies Key Topic.
HIV antibody testing: Genito-Urinary Clinic or additional site same-day testing service.
Hudson MM; Nelson WL; Ronalds CJ; Anderson J; Jeffries DJ. AIDS Care 1997 Apr;9(2):209-15
Abstract
It has been suggested that different groups of individuals, possibly those at greater risk, may choose to attend anonymous HIV services not attached to Genito-Urinary Medicine Clinics. This paper reports the results of a comparative study of documented sociodemographic profile and risk category for individuals having HIV antibody tests at a Genito-Urinary Medicine Clinic and at an additional site same-day HIV antibody testing service not attached to a Genito-Urinary Medicine Clinic but within the same hospital. A retrospective case record analysis for 12 months from 1.10.93 to 30.9.94 was performed. During the 12-month study period 954 people had HIV testing at the additional site HIV antibody testing service and 803 had HIV antibody testing at the Genito-Urinary Medicine Clinic. Of those attending the additional site testing service 218 (22.9%) were homosexual/bisexual males as compared with 128 (15.9%) of the Genito-Urinary Medicine Clinic attendees (p < 0.01). A total of 22 (2.3%) of the individuals attending the additional site service gave a history of sexual contact in Africa as compared with 52 (65%) attending the Genito-Urinary Medicine Clinic (p < 0.001). There was no significant difference in the gender or age of those having HIV antibody tests at the two locations (p = 0.82 and p = 0.39 respectively). Four hundred and seventeen (52%) of the tests performed at the Genito-Urinary Medicine Clinic were performed on those who had not already decided to have a test before attending the clinic. Of those individuals who had decided to have a test before attending, 2.5 times as many attended the Same-Day Service as attended the Genito-Urinary Medicine Clinic (954 additional site attenders compared with 384 Genito-Urinary Medicine Clinic attenders). The results suggest that to optimize patient choice and benefit from a HIV antibody testing service this should be available at both Genito-Urinary Medicine Clinics and at additional site testing services.
On-site, rapid HIV testing with same-day results and counseling.
Kassler WJ; Dillon BA; Haley C; Jones WK; Goldman A. AIDS 1997 Jul;11(8):1045-51
Abstract
BACKGROUND: New rapid HIV antibody tests have allowed provision of results and result-specific counseling on the day on initial visit, and have the potential to increase the efficiency of HIV counseling and testing. METHODS: To evaluate the use of rapid testing with same-day results in public clinics, the Single Use Diagnostic System HIV-1 rapid assay was used for a 3-month period at an anonymous testing clinic and a sexually transmitted disease (STD) clinic in Dallas, Texas. Non-reactive rapid test results were reported as HIV-negative. Reactive results were reported as 'preliminary positive'. These procedures were compared with standard testing during a baseline period, with respect to number of clients receiving results and post-test counseling, client satisfaction, counselor acceptance, cost and effectiveness at reducing HIV risk. RESULTS: Rapid testing resulted in an increase in the number of persons learning their serostatus: a 4% increase for uninfected and a 16% increase for infected clients at the Anonymous Testing Clinic; a 210% increase for uninfected patients and a 23% increase for infected patients at the STD clinic. Rapid testing resulted in a cost saving of US$ 11 per test in both the anonymous and STD clinics. Of those previously tested, 88% responded that they preferred the rapid test. In the year following initial HIV test, clients tested with rapid and standard procedures were equally likely to return to the clinic with a new STD (odds ratio, 0.97; 95% confidence interval, 0.7-1.4). CONCLUSIONS: Rapid, on-site HIV testing was feasible, preferred by clients, and, resulted in significant improvement in the number of persons learning their serostatus, without increasing the costs or decreasing the effectiveness of counseling and testing.
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