After reading The Lancet correspondence, the following letter was sent by Dr. Frerichs to Dr. Mertens (later widely circulated among international HIV/AIDS investigators).  Dr. Mertens elected not to respond. 

Personal Correspondence (June 12, 1994)

Thierry Mertens, M.D., Ph.D.

Chief, Surveillance, Evaluation, Forecasting and Health Care Support

Global Program on AIDS

World Health Organization

20, Avenue Appla

CH-1211 Geneva 2, SWITZERLAND

Dear Dr. Mertens:

When we met during your recent trip to Los Angeles, I was impressed with your open and candid manner and your apparent willingness to consider new approaches to HIV control. We discussed my concern with the Global Program on AIDS (GPA) and their apparent commitment to control policies that are well meaning but lack proven effectiveness. I commented that I am a great admirer of the World Health Organization (WHO), having served as a consultant to GPA/WHO in Geneva and to WHO/Western Pacific in the Philippines. Yet for some while I have been disturbed by their lack of interest or support for alternative HIV intervention strategies. Some in GPA seems to more concerned with protecting HIV infected persons from the wrath of society than protecting uninfected persons from viral transmission. While such a stance may be deemed appropriate by special interest groups or colleagues who practice clinical medicine, I feel that such policy is at odds with our public health mandate to prevent infection. During our conversation, I mentioned that I would willing to present to GPA/WHO an alternative strategy that features inexpensive home testing, as described in my recent viewpoint in The Lancet.[1] You felt the idea was controversial but seemed to agree that discussion was necessary, and expressed a willingness to initiate such talks when returning to Geneva.

With this in mind, I was startled and saddened by your recent response (Lancet 1994; 343: 1293) to my Lancet viewpoint. Instead of exploring ways that a home testing strategy might better serve public health, you and your colleagues expressed confusion over the intent of such an effort, linked it to mandatory testing programs, and rejected the notion out of hand. I responded to your letter and those of others with a reiteration in The Lancet of the magnitude of the HIV problem in third world countries and the desperate need for new views that offer practical alternatives for people in the field. My intention here is not to re-state my response (which I anticipate will be published), but rather to address various issues you raised in your letter. Since your confusion may have resulted from my lack of clarity, I would like to address more completely my intent. To facilitate discussion, please distribute this letter to others in your organization. I have taken the liberty of sending a copy to Dr. Piot with the hopes that he will distribute it as well. Some may share my view that new control strategies are necessary and home testing does have a roll to play. If so, I would be very willing to work with this group to flesh out details of the strategy so that it can be formally presented for consideration to governments in developing countries, the World Bank, and other international donor organizations.

First I will explain how the home testing strategy evolved. As Associate Director of the UCLA/Fogarty International HIV/AIDS Training Program, I have worked closely with Professor Roger Detels, Director of the Fogarty program, and various students and colleagues in developing countries to assist in the battle against HIV. In our travels, we found that health officials in many countries were reluctant to admit that HIV/AIDS posed a problem to their nation or region. To address this issue, we strongly emphasize the importance of surveillance to identify and control HIV, specifically sentinel surveillance with HIV prevalence in several high and low risk groups.[2]  In this regard, we are in close agreement with the position of GPA/WHO.[3]  We have involved WHO personnel in many of our workshops and both Professor Detels and I have enjoyed working with them. As a result of our collaborative efforts, sentinel surveillance programs now exist in Myanmar, Thailand, Philippines, Indonesia, and Rio de Janeiro State, Brazil.

As surveillance programs become established, the next hurtle was (and remains) to get people to use the information on HIV prevalence for program planning. Unfortunately, we have been less successful in this regard. Often health officials seem more comfortable monitoring HIV trends and commenting about the untenable burden the disease is placing on their societies, than committing themselves to tough actions stimulated by levels of HIV prevalence. Thus instead of viewing surveillance as a monitoring and control process,[4] the system is used only to monitor HIV prevalence. This reluctance to act is partially due to human nature, but also to the poor control strategies that are available. For example, we try to use principles of universal precaution or protection by admonishing people to act as if "everyone could be infected." We offer condoms and more condoms but such efforts seem to have little effect on the epidemic. The reasons are not hard to discern, but seem difficult to accept. Men are not willing to use condoms for the 75-125 coital event that occur in a typical year. They may use them every now and then, but not on a regular basis. Most condom-use surveys of the general male population show low usage, with coverage typically less than 20 percent, even in well-educated, developed countries. Within marriages, condoms remain the least favored of modern contraceptive methods. We also offer people the hope of vaccines, although no vaccines are near being available. Then we discuss the importance of access and care for sexually transmitted diseases, with the hope that fear of AIDS will improve programmatic efficiency. Finally, we focus on high risk groups, telling homosexuals and prostitutes to use condoms, and drug addicts to sterilize their needles and injection equipment. Of course new efforts are on the horizon such as vaginal microbicides and female condoms, or use of zidovudine (AZT) during pregnancy by HIV infected women to prevent infection of their offsprings, but little consideration seems to be given to cost or willingness of the population to use these methods. Instead the same underlying assumption always seems to be made: namely that people will act continuously and consistently based on education and guidance, but without knowledge of HIV status.

Like many of your colleagues at GPA/WHO, Professor Detels and I are committed to the philosophy of "information for action," at least at the community level, and have made this theme a cornerstone of our workshops and lectures. More than others, I feel that a natural extension of this philosophy is to the individual level. Here needed information is HIV status of potential sexual partners, and action is avoidance of infectious acts or protection from infection. Just as sentinel surveillance empowers communities to act in their best behalf, home testing empowers individuals to do what is necessary to prevent viral transmission. It is a simple concept, but hard to bring about in the developing world. First, we had to develop an inexpensive test that could easily be used in third world settings. In collaboration with Dr. Eugene Seymour, a dedicated physician and UCLA public health graduate who heads a small start-up company (Saliva Diagnostic Systems, Inc.), and colleagues in Myanmar and Thailand, we conducted a series of studies that demonstrate the validity of noninvasive, saliva-based HIV antibody tests [5, 6, 7]. The article in AIDS will be published in July or August and will be the largest study to date on saliva testing, and one of the few that includes both "hard testers" and "easy testers" from an on-going sentinel surveillance program. That is, we did not take a set of know HIV positive persons and known HIV negative persons and retest them with the saliva assay. Instead we took persons as they were selected for the sentinel surveillance program, and tested both their serum and saliva. I felt it was important to create as realistic an evaluation as possible, since we may not have leverage later to do such extensive and realistic field investigations. My collaborators and I are also evaluating if saliva can be used for pooling (five specimens per batch), and how long specimens can remain at ambient temperatures before the HIV antibody protein denatures. The latter is especially important if specimen collection for home testing is to be done in remote areas away from central laboratories, a necessary condition for 80 percent of people in the developing world.

While low-cost collection devices are now available (for example, WHO is planning to offer the Omni-Sal saliva collection device to member nations for a unit price of $0.56), we need to do more to evaluate inexpensive ELISA tests for use with saliva. Starting later this month we will be doing field trials in Thailand using Detect, an inexpensive assay produced by a small company in Canada, and in the next few months in Rio de Janeiro and Sao Paulo using both Detect and assay supplied by Abbott. If these assay work as well as the GACELISA (an excellent test with saliva) my colleagues and I will have reached our goal for a low-cost HIV testing device.

While these developments are taking place in the developing world, others are aiming their efforts at the United States and Europe. Likely by November or December, 1994, the Food and Drug Administration will have licensed a blood-spot home test developed by Johnson and Johnson. According to a recent article in the Wall Street Journal, Johnson and Johnson plans to sell the test for $30, far too expensive for use in developing countries. In the coming year, Epitope will likely have the Orasure saliva collection device licensed by the Food and Drug Administration, followed several months later by the Omni-Sal device of Saliva Diagnostic Systems.

What is creating this interest in home testing? It is becoming apparent to many in the United States and elsewhere that clinic-based HIV testing programs that feature blood screening, confirmatory testing, and pretest and posttest counseling are expensive undertakings, and not very efficient. Typically, US testing centers report that 1-4 percent test positive and 96-99 percent test negative. Pretest counseling typically takes 5 minutes and posttest counseling takes 15 minutes if HIV negative and 45 minutes if HIV positive.[8]  The cost of a negative test sequence is estimated to average about $50 and of a positive test sequence to average about $150.[9]  Since the vast majority of people coming for testing are HIV negative, an enormous amount of money is being spent on counseling those who are not infected. In this inefficient system, the cost of finding a single HIV positive case to counsel is in the thousands of dollars, two expensive for most developing countries, and possibly too expensive for taxpayers in the United States. As the Los Angeles Times and other news media are making people aware of how public funds are being spent, further restrictions on spending for HIV testing of an overwhelmingly HIV negative population are inevitable. Home testing offers an inexpensive means for improving the efficiency of the testing effort, and for getting more people in need to come to testing and counseling centers. As a screening tool, home tests will eliminate the "worried well" (i.e., those who think they are positive but are really negative) and alert the asymptomatic sick (i.e., those who are positive but do not know it) that they are in need of care, treatment and counseling. Since home test kits would be sold in the private sector, the cost of screening would be borne by the consumer, not by the government. The cost per detected case at public-funded testing clinics would decline as proportionately more positives come forward for testing. As a result, taxpayers would feel more inclined to fund such service centers. Home screening as envisioned would be done anonymously by those who purchase the test kits. They would collect the specimen and send it to a laboratory for anonymous testing. The results would come back to the sender either by mail to a dropoff point such as a pharmacy or grocery store, or by a telephone message. If found to be reactive with the saliva test, the person would be referred to a blood testing site (either government-sponsored or in the private sector) for confirmatory testing.

I foresee that such a test could be made available in developing countries for less than $2.00 for the collection device and ELISA test combined. Twenty cents would be drawn off the top as a licensing fee by the government, to be used to certify the testing laboratories. Thus the government would be responsible for promoting the product and ensuring the quality of the laboratories. In exchange for this support, the vendor would need to offer a product that is priced for widespread sales. Combining the best efforts of public and private sector in creative ways will be necessary if ever we are to make a dent in this complex and ever-escalating epidemic. Since many developing countries spend less than five percent of their gross national product on health, I see few funding options for government-sponsored HIV control program. This is why I favor a combined approach that involves both government and private enterprise. I am sure that there are many at the World Health Organization who would agree with this view.

POINTS OF MISUNDERSTANDING

In your letter to the editor, you and your associates addressed several issue. First, I use the term "personal testing" because individuals will use the test to evaluate either their own HIV status or that of potential sexual partners. The screening effort will have two intentions: 1) to identify HIV infected persons so as to postpone death, and 2) to identify persons who are HIV infected in order to prevent transmission to HIV negative persons. While some may feel that personal screening will not accomplish these goals and therefore should not be supported, I do not agree. Instead I feel that the issue should be addressed in the market place. If people value personal HIV testing, they will buy the home test kits and use the new-found knowledge to reduce their risk of infection. If such kits have no value, people will not buy the products and they will sit idle on shelves of drug and grocery stores until removed by frustrated merchants. I do not accept the idea that you or others have the right to deny people the use of a convenient and accurate home test, especially if they elect to buy it for personal testing. While you may be skeptical of the process, at least give the idea a chance in the freedom of the marketplace. WHO/GPA is willing to accept the effectiveness of condom-promotion programs, and is willing to gamble on vaginal microbicides or female condoms. The same spirit of openness and willingness to try new things should apply to HIV home testing.

Second, counseling as you envision it is an expensive activity (see above). While it may be acceptable in wealthier societies (and even here in the United States the notion is being debated), developing countries cannot afford such luxuries. Home screening will alert people of their risk and encourage those who test positive to come forward for additional testing and care. If funds are available, it is screened-positive group that would be counseled. The nature and extent of counseling services must be determined by each society, taking into account the cost and effectiveness of the effort. Saying that testing without counseling is unethical and therefore if money is limited it is better to not test at all, seems strange to me. I prefer to have these issues debated by local governments who know their financial situation, rather than dictated by international experts or organizations.

Third, the process of sending the collected specimen to a laboratory will be worked out within each country. Once the test is widely available, we will see if women are able to use it to test their partners, and if both partners are able to wait until the results come to engage in sexual relations. As mentioned above, I would rather have such issues evaluated after the product is being widely used, rather than deciding ahead of time by those who feel such a strategy will not work.

Fourth, you comment that "the potential for financial profit for the marketeers of testing kits is clearly large if populations are led to believe that testing slows HIV spread." This is a curious statement, given your earlier comments that home tests would not be acceptable to the general public. Like you seem to imply in this contradictory statement, I anticipate that there will be an enormous demand for the tests, especially if price is low. I am less concerned than you and your associates with the profit margin of "marketeers," feeling that competition, government certification, and the free marketplace will serve to control price and quality. This is how we sell condoms, drugs, spermicides and other related items in most societies. I am sure that you do not lament profit-making in these enterprises. Home testing should be no different.

Fifth (and final), I was perplexed by your twist of logic when you introduced your objection to mandatory premarital testing. In the previous paragraph you had just finished lamenting profits that would be made by marketeers from the widespread sales of home tests. Then you implied that people would be "unwilling to undergo testing" and used mandatory premarital testing in the United States to support your argument. You are dealing with two separate questions. Will people voluntarily purchase home tests for use in the privacy of the home? Do people in the United States accept mandatory premarital testing for HIV if they are given a choice? Concerning the first question, I favor leaving it to the private sector to provide the answer. People will either buy or not buy such tests, depending on demand and price. The answer to the second question is more complex. Specifically, you stated in your letter that "in a state of the USA where premarital testing was made compulsory, a large proportion of premarital couples got married elsewhere." Actually, there were two states involved in the analysis of this issue: Louisiana and Illinois [10]. Both states began mandatory premarital HIV screening on January 1, 1988, when the prevalence of HIV was likely less than one-half percent. In Illinois, 16 percent fewer marriage licenses were issued in 1988 than the average in 1986 and 87. Correspondingly, the number of marriages increased by 7 percent in states surrounding Illinois. In Louisiana, there were 9 percent fewer marriages in 1988 than the average of 1986-87, not unlike 7 percent decrease in its surrounding states. While there are well-known perils to making inferences from ecological data, lets assume that the reduction is true and that it is due to people not wanting to be HIV tested. I would not categorize 16 percent or 9 percent as "a large proportion," since 84-91 percent of the population was willing to be tested. Peterson et al. concluded their policy analysis of this issue by stating, "compared with other HIV prevention programs, mandatory premarital screening would be expensive and would probably have a minor impact on the HIV epidemic."[10a] That is, their objection was due more to cost and the low level of HIV in the tested population, rather than citizen non-participation. Subsequently McKay and Phillips published a cost-benefit analysis of mandatory premarital testing for HIV in the United States and concluded, "In the cost-benefit analysis, the benefit-cost ratio in the most likely scenarios ranges between 3.1 and 28.2."[11] That is, the benefits of such testing exceeded the cost by a considerable margin, and this in a country such as the USA with a low HIV prevalence. The McKay and Phillips analysis has not been repeated for developing countries with much higher HIV prevalence levels but less income. It is likely, however, that such an analysis would also find that benefits far exceed the costs.

CONCLUDING REMARKS

At present I do not favor mandatory premarital testing, but want instead to give people the option of testing themselves for HIV on a voluntary basis. Because they are paying for the home test, the results belong to them and only them, and thus should not be reported to the government. The government, however, may want to monitor laboratories for summaries tallies of test findings. Since testing in the private sector would be done anonymously, the names of those who test positive would not be known to the government. Once people come forward for confirmatory testing and to seek the assistance of government or private physicians, the issues of reporting and confidentiality remain as they are in the current care delivery system.

While it is clear that I differ with some in GPA/WHO, it is likely that others will agree with me and be supportive of personal screening. Rather than limit myself to debates in The Lancet or to letters such as this, I trying to share my ideas with colleagues in developing countries and have them decide if the notions do or do not make sense. Starting next week I will be speaking to a group in Honolulu on the policy-aspects of HIV. Included in this workshop will be officials from HIV/AIDS control programs in China, Taiwan, Philippines, Indonesia, Myanmar, Thailand, Sri Lanka, Laos and Vietnam. Next I will journey to Ho Chi Minh City where Professor Detels and I will be giving an HIV workshop to HIV/AIDS control officers from throughout Vietnam. After that, I travel to Bangkok to give a talk several times entitled, Home testing - an alternative strategy for HIV control at the Chulalongkorn University, the Armed Forces Institute of Medical Sciences, the Ministry of Public Health, and the CDC HIV/AIDS Collaboration. Next I will be in Yangon, Myanmar giving the same talk to officials of the Department of Health and completing our field research on the effects of time and temperature on the saliva test. Finally, I will be stopping in Manila to present my talk at the University of the Philippines College of Public Health, and possibly at the Department of Health.

My purpose in these various workshops and presentations is not primarily to encourage home testing. Instead, I am trying to address various options health officials have available to confront the HIV epidemic and to suggest an additional option that should be considered, namely, information on HIV status for personal action. Most have welcomed my presence because others have not addressed this option. Rather than disagreeing with you and associates at GPA/WHO on this issue, I favor working with your organization to further develop the notion of personal screening and to assist governments in establishing private sector testing programs. Those of us in the world of ideas and service do better for the public when we are able to work together.

Starting on June 18, I will be away from my office both on matters described above and on vacation. Therefore please do not take offense if you respond and I do not write back until August. I look forward to continuing this dialogue with both you and others at GPA/WHO who view the concept of home testing in a more favorable light.

Sincerely,

Ralph R. Frerichs, D.V.M., Dr.P.H.

Professor and Chairman

Department of Epidemiology

REFERENCES

1. Frerichs RR. Personal screening for HIV in developing countries. Lancet 1994; 343: 960-962.

2. Frerichs RR, Ungchusak K, Htoon MT, Detels R. Sentinel surveillance in Thailand - an example for developing countries. Asia-Pacific Journal of Public Health 1994; (In Press)

3. Chin J. Public health surveillance of AIDS and HIV infections. Bulletin of the World Health Organization 1990; 68(5): 529-536.

4. Frerichs RR. Epidemiologic surveillance in developing countries. Annual Review of Public Health 1991; 12: 257-280.

5. Frerichs RR, Htoon MT, Eskes N, Lwin S. Comparison of saliva and serum for HIV surveillance in developing countries. Lancet 1992; 340: 1496-1499.

6. Frerichs RR, Eskes N, Htoon MT. Validity of three saliva assays for HIV-antibodies. Journal of Acquired Immune Deficiency Syndromes 1994; 7(5): 522_524.

7. Frerichs RR, Silarug N, Eskes N, et al. Saliva-based HIV antibody testing in Thailand. AIDS 1994; (In Press)

8. Otten MW, Zaidi AA, Wroten JE, Witte JJ, Peterman TA. Changes in sexually transmitted disease rates after HIV testing and posttest counseling, Miami, 1988 to 1989. American Journal of Public Health 1993; 83(4): 529-533.

9. Phillips KA, Lowe RA, Kahn JG, Lurie P, Avins AL, Ciccarone D. The cost-effectiveness of HIV testing of physicians and dentists in the United States. JAMA 1994; 271(11): 851-858.

10. Petersen LR, White CR. Premarital screening for antibodies to human immunodeficiency virus type 1 in the United States. The Premarital Screening Study Group. American Journal of Public Health 1990; 80(9): 1087-1090.

10a. Same reference as #10

11. McKay NL, Phillips KM. An economic evaluation of mandatory premarital testing for HIV. Inquiry 1991; 28(3): 236-248.