... by mail and asked to call for an appointment at the blood center to discuss a ... the nurse answered questions and provided counseling, if a donor appeared to ...
Sociodemographic and Behavioral Characteristics of HIV Antibody-Positive Blood Donors PAUL D. CLEARY, PHD, ELEANOR SINGER, PHD, THERESA F. ROGERS, PHD, JEROME AvoRN, MD, NANCY VAN DEVANTER, RN, STEVEN SOUMERAI, DSc, SAMUEL PERRY, MD, AND JOHANNA PINDYCK, MD Abstract: This paper describes the sociodemographic and behavioral characteristics of 173 blood donors who were confirmed by Western blot tests to have antibodies to human immunodeficiency virus (HIV), the etiologic agent for acquired immunodeficiency syndrome (AIDS). Seropositive donors were predominately young, unmarried, and male, and major risk factors could be identified for almost all donors. However, more than 20 per cent of the study
participants were women, and many participants were not aware that they were at risk of infection. The heterogeneity of the study population, the lack of awareness among many subjects of risk factors and self-exclusion procedures, and the high level of distress among many subjects after notification, emphasize the need for intensive, well-designed education and support programs. (Am J Public Health 1988; 78:953-957.)
Introduction Since acquired immunodeficiency syndrome (AIDS) was first discovered in 1981, a great deal has been learned about the epidemiology of human immunodeficiency virus (HIV) infection. ' Most research, however, has focused on persons who have developed overt symptoms of AIDS, and studies of seropositive individuals who do not have AIDS have involved primarily sexually active homosexual men, intravenous drug users, and to a lesser extent hemophiliacs.7 Relatively little is known about persons who are infected but have not developed AIDS and are not aware of their infection. Even less is known about the characteristics of infected persons who are not self-described as being in the primary risk groups mentioned above. Information about people who are HIV antibody positive but have not developed AIDS is important for the development of public health programs aimed at promoting behavior change among such individuals. This paper reports on the sociodemographic and behavioral characteristics of 173 blood donors found to be seropositive for HIV antibodies at the New York Blood Center (NYBC). Background All persons donating blood to the NYBC since 1983 have been asked to indicate on a confidential form whether their blood could be used "for transfusions" (if they were not at risk for HIV infection) or should be used for "studies only" (if they were in an AIDS risk group).8 In March 1985, tests to screen blood for antibodies to HIV were developed and licensed for use by blood blanks. Since April 1985, all donations to the NYBC have been screened for HIV antibodies. In addition, the confidential self-exclusion procedure has been continued, and all blood from donors who do not indicate that their blood may be used "for transfusion" is removed from the distribution blood supply regardless of antibody screening results.
The first step in the HIV screening process is to conduct an enzyme immunoassay (EIA). If there is a positive EIA result, the unit of blood tested is not used for transfusion and two additional EIA tests are conducted. For any sample with two positive EIA tests, a Western Blot (WB) assay is conducted to confirm the donor's HIV antibody status. Donors with a positive WB are contacted by mail and asked to call for an appointment at the blood center to discuss a
Address reprint requests to Paul D. Cleary, PhD, Associate Professor, Department of Social Medicine and Health Policy, Division on Aging, Harvard Medical School, 643 Huntington Aveune, Boston, MA 02115. Dr. Avorn is Associate Professor, and Dr. Soumerai is Assistant Professor, both with that same department at Harvard; Dr. Singer and Dr. Rogers are Senior Research Scholars at Columbia University; Ms. Van Devanter is Director of Community Services Department, and Dr. Pindyck is Research Associate, both at the New York Blood Center; Dr. Perry is Associate Professor of Psychiatry at Cornell University Medical College. This paper, submitted to the Journal September 14, 1987, was revised and accepted for publication January 26, 1988. © 1988 American Journal of Public Health 0090-0036/88$1.50
AJPH August 1988, Vol. 78, No. 8
"finding of importance to their health." No information is given about which test will be discussed. Those who do not respond to this request are sent, if necessary, two follow-up letters to encourage them to come to the NYBC to receive their results. If all three attempts to contact a donor fail, a certified letter is sent explaining the blood test results and encouraging him/her to come to the NYBC for personal counseling or to contact a physician for further information. Methods
The data reported in this paper are from a pilot study designed to collect information that would be useful in developing a randomized controlled trial of two programs for providing information, health education, and psychosocial support to HIV positive donors.9"'0 The eligible subjects for this study were blood donors with a positive confirmatory
WB test who came to the NYBC to learn of their results during the pilot period: September 1985 through June 30,
1986. A nurse clinician with psychiatric training saw each of these donors, and great care was taken to safeguard their confidentiality. Donors were given identification numbers in the mailings and asked to provide identification before they were given information about the test results. A nurse clinician explained the meaning of the test finding, the potential impact of infection on the donor's health, and ways to prevent the spread of the virus to others.'0 All donors were given written materials about HIV and viewed a videotape about HIV in a private room. While donors viewed the tape, the nurse answered questions and provided counseling, if a donor appeared to be distressed. The nurse subsequently provided emotional support and assessed the donor's ability to cope with the information. After notification and counseling, the nurse asked donors if they would be willing to take part in a research study. Those who agreed to participate had a medical history taken and received a brief physical examination. The nurse also drew a blood sample from consenting donors for verification of HIV antibody status and other serologic testing, and answered any questions donors had. The medical history 953
CLEARY, ET AL.
included questions about possible risk factors for HIV infection, and the physical examination included assessment of symptoms that could be due to HIV infection. Study participants next were asked to complete a questionnaire that included questions about awareness of the testing procedure, knowledge about HIV and AIDS, anticipated behavior changes, and psychological distress. To evaluate the amount of distress experienced by donors immediately after notification, the questionnaire included a single question about how worried or concerned they were and asked them to complete the Center for Epidemiologic Studies Depression (CES-D) scale."11,2 To assess how likely donors would be to inform others of their test results, the questionnaire asked whether they intended to tell their test results to specified people. With blood donors who did not report a major risk factor on the initial questionnaire, we conducted a follow-up interview to better understand the source of infection. Each of these donors who could be contacted and who consented was interviewed at a subsequent visit to the NYBC by a specially trained interviewer from the New York City Department of Health who asked a series of detailed questions to elicit possible sources of infection. Those questions covered risk factors that were not included in the initial questionnaire. Results A total of 173 donors agreed to participate in the pilot study. One hundred and sixty-eight completed the medical history and physical examination, as well as the questionnaire on knowledge, attitudes, anticipated behavior change, and distress. An additional three donors completed only the questionnaire. Five who completed the medical history did not have time to answer the questionnaire, and two did not have time to provide any information at the notification visit but did complete a follow-up interview two weeks later. The 173 participants represent 51 per cent of all seropositive blood donors sent notification letters during the study period. Approximately 9 per cent of seropositives could not be contacted, two died prior to notification, about 18 per cent of the donors contacted never made an appointment for notification, 8 per cent appeared for notification and agreed only to have laboratory work done, and the other donors appeared for notification but declined to participate in the study. The proportions of men and women who agreed to participate in the study were nearly identical (51 per cent vs 50 per cent), the proportion of participants in different age groups was not significantly different, and the participation rate of those who donated "for transfusion" (49 per cent) was close to that of "studies only" donors (55 per cent). The sociodemographic characteristics of the antibodypositive blood donors who agreed to participate in the study are shown in Table 1. These results are presented separately for the donors who indicated that their blood should be used for transfusion and those who indicated "studies only." Consistent with the characteristics of AIDS patients nationally, seropositive blood donors tended to be young, unmarried, and male. Almost 30 per cent of the positive donors, however, were or had been married. Those who indicated that their blood should be used for "study only" were more likely to be male, White, better educated, and never married. The proportion of men and women who reported major categories of risk factors on the initial questionnaire are presented in Table 2. It is important to note that these are only risk factors. In no case was it possible to determine the actual route of transmission, and many donors had more than one 954
TABLE 1-Soclodemographic Characteristics of Seropositive Blood Donors
Characteristics Gender Male Female
Age (years) 18-25 26-30 31-35
36-45 46-55 56-65
Race/Ethnicity White Black
Hispanic Other Education Did not complete high school High school graduate Some college and/or post-high school
training College graduate More than college Marital Status
Never married Married Separated or divorced Widowed
For Transfusion (N:1 12)
Studies
(N:61)
Total N (%)
77 35
58 3
135 (78) 38 (22)
33 27 26 16 8 2
14 17 18 10 2 0
47 (27) 44 (25) 44 (25) 26 (15) 10 (6) 2 (1)
37 38 29 2
33 17 7 0
70 (43) 55 (32) 36 (22) 2 (1)
10 23
1 4
11 (7) 27 (16)
42 20 14
24 18 12
66 (39) 38 (23) 26 (16)
68 22 17 1
50 3 6 0
118 (71) 25 (15) 23 (14) 1 (0.6)
Only
risk factor. More than three-fourths of the men in our study reported intimate sexual contact with another man since 1977 and a substantial number reported intravenous (IV) drug use or having had sexual contact with an IV drug user. Among the 104 seropositive men in our sample who reported at least one sexual contact with another male, 62 reported that they had also had sexual relations with a woman since 1977. Nine of these men reported 20 or more contacts, and one reported having had 100 female sexual partners since 1977. All of the 10 male donors who reported using IV drugs on the initial questionnaire reported having sexual relationships with women since 1977. Seven of the IV drug users reported having sexual relationships with 10 or more women in that time. Sixteen of the men reported no major risk factors on this initial interview. The risk factor most frequently reported on the initial interview by women was sexual contact with an IV drug user. One-half of the women did not report being in one of the major risk categories on the initial questionnaire. The subsequent interview by the Department of Health interviewer identified a number of additional possible risk factors. Among the 16 men who did not initially report a major risk factor, five could not be interviewed. Of the 11 interviewed, two were bisexual, one was an IV drug user, one had sexual contact with someone who had received a transfusion and seven had no major risk factor that could be identified. Two of the women who did not initially report a risk factor could not be interviewed; one of these women had received a transfusion. Among the 17 interviewed, four women reported having sexual contact with IV drug users, six had sexual contact with a bisexual male, one reported sexual contact with a Haitian, two had received a transfusion, and one reported having sexual relations with a partner who had received a transfusion. In three of the 17 Department of AJPH August 1988, Vol. 78, No. 8
HIV ANTIBODY-POSITIVE BLOOD DONORS TABLE 2-Reported Risk Factors for HIV Infection among Seropositive Blood Donors*
Men
Risk Factors Sexual contact with a male since 1977 (males only) Sexual contact with a homosexual male since 1977 (women only) Sex with an IV drug user since 1977 Used IV drugs Partner had sex with a homosexual male since 1977 No self-reported risk factor identified in initial questionnaire No risk factor identified in additional interview
For Transfusion (N = 74)
51
Studies
Women
(N = 56)
Total N (%) (N = 130)
For Transfusion (N = 35)
Studies Only (N = 3)
Total (N = 38)
53
104 (80)
_
_
_
4
0
4
Only
_-
-
11 8
4 2
15 (12) 10 (8)
13 0
2 1
15 1
42
43
85 (66)
3
0
3
14
2
16 (12)
18
1
19
9
2
1 1 (9)
3
1
4
*Many donors had more than one risk factor
TABLE 3-Expectations and Beliefs about Testing among Seropositlve Blood Donors
Number of respondents who knew that their blood would be tested for HTLV-111 antibodies Expected test to show that they had been exposed to the virus
For Transfusion N(%)
Studies Only N (%)
Total N (%)
62 (61)
44 (75)
106 (66)
4 (4)
10 (20)
14 (10)
Health interviews with women, no potential risk factor could be identified. We also analyzed seropositive donors' responses to several questions about their awareness of the testing and exclusion procedures (Table 3). In spite of the publicity that blood screening was received, and in spite of the fact that all donors signed an informed consent form that explained the testing procedure, about a third of the donors indicated that they did not know or were not sure that their blood would be tested for HIV antibodies (referred to as HTLV-III antibodies in the questionnaire). Four who gave blood "for transfusion" said that when they donated blood, they expected a positive test result. Only 54 per cent of those with no more than a high school education, but almost 75 per cent with at least a college education said they knew that their blood would be tested. Fifty-six per cent of those who reported no major risk factors AJPH August 1988, Vol. 78, No. 8
said they knew their blood would be tested, whereas 68 per
cent of those with one or more risk factors said they knew
about the testing program. Whites were most likely (74 per cent), Blacks less likely (64 per cent), and Hispanic and Asian donors least likely (54 per cent) to be aware of the testing program. When education, race, number of risk factors, and self-exclusion were used in a regression model to predict knowledge of the testing program, race was the least important predictor of knowledge and no individual variable was statistically significant. With race removed from the equation, education was the only significant predictor. During the notification session, the nurse clinician instructed seropositive donors about the importance of informing their physician of their blood test results and they were counseled on how to share the information with someone whom they could trust and who could provide support for them. A high proportion of donors indicated that they intended to tell their results to others and, consistent with advice provided during the notification visit, donors were most likely to report that they intended to tell health professionals and sexual partners about their results (Table 4). The responses to the questions in the CES-D about distress indicated that the donors were very upset: 28.5 per cent had scores of 16 or higher. In representative community samples, scores on the CES-D above 16 are usually interpreted as indicating that a person is at high risk of depression. Typically, 13 to 19 per cent of community samples score 16 or higher on the CES-D.12 On the single question about distress, more than 80 per cent of the seropositive donors indicate that they were somewhat or very worried or concerned. The majority of respondents indicated that they 955
CLEARY, ET AL. TABLE 4-Reaction to Notification about HIV Infection among Seropositive Blood Donors (N = 166)
Persons donor reported planning to tell: Physician Sexual partner Dentist Family member Counselor Friends
% of Donors Who Would Reveal Test Results 77.8 72.7 62.8 35.1 26.3 21.6
thought they had a relatively low probability of developing AIDS in the next five years, but 28 per cent thought that they had more than a 40 per cent chance. Discussion
The data presented in this paper are from seropositive blood donors, a selected subset of all HIV-infected individuals, and these results are not generalizable to that population. However, they do provide some important insights into the types of people infected with HIV. These data are similar in some respects to the distribution of risk factors among AIDS patients in the entire country. The predominant risk factors for HIV infection are being a sexually active homosexual, a user of illicit intravenous drugs, or a hemophiliac.7"l3'8 For example, in 1985 it was reported that about 76 per cent of the persons in the country with AIDS were homosexual or bisexual and 15.6 per cent were IV drug users.19 Among males in our study, 80 per cent were homosexual and 11 per cent were intravenous drug users. Our data are different from national statistics in several important respects, however. The proportion of seropositive donors in this study who are women is higher. Furthermore, whereas intravenous drug use is the main risk factor among women nationally,20 only one of the women in our sample admitted to intravenous drug use. The heterogeneity of the sample is striking. The fact that 22 per cent of the sample were women is noteworthy in light of the fact that earlier results from screening of blood donors at other sites indicated that 92 per cent of confirmed positive donors were men.2' Also, the fact that most of the men who reported homosexual contacts and all male IV drug users reported having sexual relations with women reinforces the view that the virus may not be as restricted to the gay community, hemophiliacs, and IV drug users in coming years. There has been a vigorous attempt over the past few years to protect the blood supply from HIV virus by asking people at risk of infection not to donate blood as well as by screening donations for HIV antibodies. Although donors may be aware of the inadvisability of donating blood for transfusion, many may feel social pressure to participate in a blood donation drive at their place of work. As indicated above, the NYBC requests donors at high risk of HIV infection to indicate that their blood should be used for " studies only."8 This program appears to have had an effect. The rate of WB confirmed positives in the 98 per cent of donors who gave blood "for transfusion" is 8 per 10,000. Among "studies only" donors, the rate is 24 times higher.'0 It is noteworthy, however, that a substantial number of donors who acknowledged major risk factors for HIV infection had donated blood and indicated that it could be used for transfusion (Table 2). Sixty men and 17 women who donated blood for transfusion and who were seropositive acknowl956
edged a major risk factor for HIV infection at the initial notification interview. When the nurses interview serpositive donors, they do not know whether they donated for transfusion and so we could not ask donors directly why they did not select the appropriate donation category. The lack of awareness that donated blood would be tested, the lack of compliance with the self-exclusion program, especially among donors with less education, and the high levels of psychological distress at notification emphasize the importance of developing better information for all blood donors and intensive notification and support programs for seropositive individuals. HIV screening programs among blood donors will be maximally effective in preventing the spread of infection only if meaningful information can be provided and individuals can be induced to change their behavior in ways that will be beneficial to themselves and others. These data suggest that such programs should be sensitive to the special needs of persons with less education and in different ethnic groups. A necessary component of such a program probably is psychosocial and mental health support and counseling. Clearly, such a task is formidable, but alternative approaches are now being evaluated.9"10 ACKNOWLEDGMENTS
This research was supported by grants from the National Heart, Lung, and Blood Institute (HL 35403-0151), the National Institute of Mental Health (MH15783), the AIDS Institute, and the New York State Department of Health.
REFERENCES
1. Curran JW, Morgan WM, Hardy AM, Jaffe HW, Darrow WW, Dowdle WR: The epidemiology of AIDS: Current status and future prospects. Science 1985; 229:1352-1357. 2. Barre-Sinousi F, Chermann JC, Rey F, et al: Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immunodeficiency syndrome (AIDS). Science 1983; 220:868-870. 3. Popovic M, Sarngadharan MG, Read E, Gallo RC: Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre-AIDS. Science 1984; 224:497-500. 4. Gallo RC, Salahuddin SZ, Popovic M, et al: Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS. Science 1984; 224:500-503. 5. Levy JA, Hoffman AD, Kramer SM, Landis JA, Shimabukuro JM, Oshiro LS: Isolation of lymphocytopathic retroviruses from San Francisco patients with AIDS. Science 1984; 225:840-842. 6. Coffin J, Haase A, Levy JA, et al: Human immunodeficiency viruses. (Letter) Science 1986; 232:697. 7. Carpenter CCJ, Mayer KH: Advances in AIDS and HIV infection. Adv Intern Med 1987; 33:1-62. 8. Pindyck J, Waldman A, Zang, et al: Measures to decrease the risk of acquired immunodeficiency syndrome transmission by blood transfusion. Evidence of blood donor cooperation. Transfusion 1985; 25:3-9. 9. Cleary PD, Rogers TF, Singer E, Avorn J, Van Devanter N, Perry S, Pindyck J: Health education about AIDS among seropositive blood donors. Health Educ Q 1986; 13:317-329. 10. Pindyck J, Avorn J, Cleary P, Rogers T, Singer E, Van Devanter N, Perry S, Soumerai S, Sencer D: Notification of anti-LAV/HTLV-III positive blood donors: Psychosocial, counseling and care issues. In: Petricciani JC, Gust ID, Hoppe PA, Krijnen HW (eds): AIDS: The Safety of Blood and Blood Products. New York: John Wiley & Sons, 1987; 269-280. 11. Radloff LS: The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas 1977; 1:385-401. 12. Boyd JH, Weissman MM, Thompson WD, Myers JK: Screening for depression in a community sample. Arch Gen Psychiatry 1982; 39:1195-1200. 13. Barnes DM: AIDS: Statistics but few answers. Science 1987;
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14. Hardy AM, Allen JR, Morgan WM, Curran JW: The incidence rate of acquired immunodeficiency syndrome in selected populations. JAMA
1985; 253:215-220. 15. Kingsley LA, Kaslow R, Rinaldo CR, Detre K, Odaka N, VanRaden M, Detels R, Polk BF, Chmiel J, Kelsey SF, Ostrow D, Visscher B: Risk factors for seroconversion to human immunodeficiency virus among male homosexuals. Lancet 1987; 1:345-348.
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HIV ANTIBODY-POSITIVE BLOOD DONORS 16. Polk BF, Fox R, Brookmeyer R, Kanchanaraksa S, Kaslow R, Visscher B, Rinaldo C, Phair J: Predictors of the acquired immunodeficiency syndrome developing in a cohort of seropositive homosexual men. N EngI J Med 1987; 316:148-153. 17. Stevens CE, Taylor PE, Zang EA, Morrison JM, Harley EJ, Rodriguez de Cordoba S, Bacino C, Ting RCY, Bodner AJ, Sarngadharan MG, Gallo RC, Rubinstein P: Human T-cell lymphotropic virus type III infection in a cohort of homosexual men in New York City. JAMA 1986; 255:2167-2172.
18. Stoneburner RL, Chiasson MA, Solomon K, Rosenthal S: Risk factors in military recruits positive for HIV antibody. N Engl J Med 1987; 315:1355. 19. Sivak SL, Wormser GP: How common is HTLV-III infection in the United States? N Engl J Med 1985; 313:1352. 20. Guinan ME, Hardy A: Epidemiology of AIDS in women in the United States. JAMA 1987; 257:2039-2042. 21. Schorr JB, Berkowitz A, Cumming PD, Katz AJ, Sandler SG: Prevalence of HTLV-III antibody in American blood donors. (Letter) N Engl J Med 1985; 313:384-385.
AIDS Products in Development: PMA Survey The Pharmaceutical Manufacturers Association (PMA) has released its latest quarterly survey on the development of AIDS-related drugs, showing that 46 companies are involved in developing 50 potential AIDS-related drugs and vaccines. The April 1988 survey also shows that there are 23 diagnostics in development and 10 approved and available. The 50 AIDS-related drugs and vaccines under development are in various stages, ranging from early research in animals to clinical testing in humans. The list includes 16 anti-virals, 21 immunomodulators, three anti-infectives, and 10 vaccines. Which of the drugs will emerge next under approval by the Food and Drug Administration (FDA) is unknown. The United States system of new drug approvals is perhaps the most rigorous in the world, proceeding through numerous steps in the process, including: * Preclinical Testing-Extensive laboratory and animal testing determines if the compound is biologically active and safe. * Investigational New Drugs (IND)-application must be filed with the FDA, showing the results of all animal testing and how the drug is made. * Human Testing (Clinical)-involves three phases of testing, each involving larger numbers of humans than the previous one. -Phase I: Safety Studies and Pharmacological Profiling-to determine the drug's pharmacological actions, safe dosage range, how it is absorbed, distributed, metabolized and excreted, and duration of its action. Phase I usually takes less than one year. -Phase II: Pilot Efficacy Studies: Controlled studies in 200 to 300 volunteers assess the drug's effectiveness, while continuing animal and human studies determine the drug's safety. This phase may require two years. -Phase III: Extensive Clinical Trials usually involve 1,000 to 3,000 volunteer patients in clinics and hospitals. The drug is administered by physicians to patients having the condition the drug is intended to treat. Such studies confirm earlier efficacy studies and identify low-incidence adverse reactions. Phase III lasts about three years. * New Drug Application (NDA)-Following completion of Phase III, the drug sponsor must file an NDA with the FDA, containing all the information gathered. NDAs typically run into thousands of pages, and must include the chemical structure of the drug, scientific rationale and purpose, animal and laboratory studies, results of all tests in humans, formulation and production details, and proposed labeling. The NDA process of FDA takes two to three years. * Approval-After approval, the drug company is required to submit periodic reports to FDA, including adverse reaction data as well as production, quality control, and distributions records. In some cases, FDA requires affirmative post-marketing monitoring or additional studies to evaluate long-term effects. According to PMA President Gerald J. Mossinghoff, it takes an average of 10 years to develop a new drug for diseases that are better understood than AIDS. "It is clear," he said, "that our companies are conducting an extraordinary amount of research on AIDS." All parties to the drug development process are compressing time, seeking to bring remedies, vaccines and diagnostics from laboratory to marketplace in record time. In the brief period since AIDS has been known as a disease, the HIV (human immunodeficiency virus) has been identified and isolated, and two AIDS-related drugs have been approved and made available, he stated. To obtain a copy of the PMA survey chart showing AIDS-related drugs in development, and to receive this information on a regular basis, send your request in writing to: Communications Divisions, Pharmaceutical Manufacturers Association, 1100 15th Street, NW, Washington, DC 20005; telephone
202/835-3400.
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