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PubMed1999

HIV counselling and testing: overemphasizing high acceptance rates a threat to confidentiality and the right not to know.

OBJECTIVE: To examine factors affecting the readiness for HIV-related voluntary confidential counselling and testing (VCT). METHODS: In a population-based HIV survey in selected urban and rural areas in Zambia, adults aged > or = 15 years were selected by stratified random cluster sampling. The participants were asked to provide a saliva sample for anonymous HIV testing (n=4812, consent rate 93.5%) and, as a part of an interview, were asked about previous HIV testing experience and if they wished to be counselled and tested for HIV. Those indicating interest (initially willing) were provided with an invitation letter to see a counsellor. In rural areas, VCT was provided by personnel brought in from outside the local community, whereas in urban areas it was provided by locally recruited staff. RESULTS: The overall HIV test rate was 6.5%, but rates appeared to be considerably biased towards higher educational groups. The proportion initially willing was 37% while 3.6% actually came for counselling and were tested (9.3% of those initially willing), of which 47% returned for the result. Actual use was four to five times higher in rural compared with urban areas. Self-perceived risk and high-risk behaviour were positively associated with initial willingness but not with actual use. CONCLUSIONS: The readiness for VCT in the general population was found to be very low. Provision factors such as concerns about confidentiality and length of time waiting for the test result contributed to the low utilization rate. Results of this study contrast sharply with reported VCT acceptance rates of 70-90% among women attending antenatal care in Zambian and in other African populations, suggesting an urgent need to evaluate testing policy and practice of antenatal VCT in particular.

AIDS Serodiagnosis↗
PubMed1997

Factors associated with HIV testing among sexually active adolescents: a Massachusetts survey.

OBJECTIVE: To assess sexually active adolescents' knowledge, attitudes, and behaviors associated with human immunodeficiency virus (HIV) testing and to determine the factors important in their decision to obtain voluntary HIV testing. DESIGN: Anonymous, random, digit-dial telephone survey undertaken in 1993. SETTING: Massachusetts households. PARTICIPANTS: Adolescents, 16 to 19 years of age. RESULTS: Of the 567 adolescents surveyed who had sexual intercourse within the past year, 127 (22%) had received HIV testing, with 54 (10%) stating that this testing was for personal reasons. A "great deal" or "some" worry about getting HIV/acquired immunodeficiency syndrome (AIDS) was expressed by 51%, and 56% felt that it was at least a little likely that they will get AIDS. Misconceptions were common about aspects of HIV testing: 35% did not believe or did not know that the HIV test results were kept in confidence, 19% thought that AIDS testers informed partners if the results were positive, and 30% did not think that the HIV test was very accurate. Although 92% (452/490) had seen a physician in the past year, only 30% (136/452) had ever discussed AIDS with a doctor. Multivariable analysis identified five factors as independently associated with voluntary adolescent HIV testing: 1) having had more than one sexual partner within the past year [odds ratio (OR): 2.9; 95% confidence interval (CI): 1.5, 5.5]; 2) believing that condoms are only somewhat effective at preventing the spread of AIDS (OR: 2. 6; 95% CI: 1.4, 4.8); 3) having discussed AIDS with a doctor (OR: 2. 6; 95% CI: 1.4, 4.8); 4) not having had a teacher discuss AIDS (OR: 2.2; 95% CI: 1.2, 4.2); and 5) believing that a positive test result means one has AIDS as opposed to carrying the virus (OR: 2.0; 95% CI: 1.1, 3.7). High-risk behavior of infrequent condom use and a history of a sexually transmitted disease were not significantly associated with voluntary HIV testing. CONCLUSION: Among sexually active Massachusetts adolescents, voluntary HIV testing is uncommon. Teens who have had multiple sexual partners and who do not believe condoms are effective in preventing transmission were most likely to have been tested. Issues requiring clearer communication to patients include the testing process, its availability, and confidentiality. Physicians can play an influential role in the promotion of HIV testing by discussing HIV risk behaviors with patients and offering those at risk voluntary HIV counseling and testing.

AIDS Serodiagnosis↗
PubMed1995

The case against mandatory newborn screening for HIV antibodies.

The paper examines the controversy surrounding legislative proposals in New York State that would require amending the public health law's stringent confidentiality provisions; the legislation calls for "unblinding" the results of a 7-year old statewide HIV seroprevalence study that tests newborns for HIV antibodies in order to track the incidence of HIV infection among parturient women. The pivotal point is made that mandatory disclosure of the test results is tantamount to mandatory testing of the mother, since presence (or absence) of HIV antibodies conclusively reveals the mother's HIV status. The author presents the history of the epidemiological study and documents the ongoing discussion of mandatory testing, within the medical, bioethical and public health community. Citing numerous papers, including the report of the Subcommittee on Newborn Screening of the New York State AIDS Advisory Council, the author--a member of both the council and its subcommittee--argues against the principle of mandatory testing in general and "unblinding" of the seroprevalence survey in particular. Besides making a strong argument from the ethical viewpoint, the paper provides ample medical data to support the argument that mandatory testing of newborns is poor public health policy that would be essentially ineffectual in the effort to stem the spread of HIV.

Advisory Committees↗
PubMed1997

Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective double blind study.

OBJECTIVES: (a) To assess the impact of HIV status (HIV negative, HIV positive, AIDS) on the outcome of patients admitted to intensive care units for diseases unrelated to HIV; (b) to decide whether a positive test result for HIV should be a criterion for excluding patients from intensive care for diseases unrelated to HIV. DESIGN: A prospective double blind study of all admissions over six months. HIV status was determined in all patients by enzyme linked immunosorbent assay (ELISA), immunofluorescence assay, western blotting, and flow cytometry. The ethics committee considered the clinical implications of the study important enough to waive patients' right to informed consent. Staff and patients were blinded to HIV results. On discharge patients could be advised of their HIV status if they wished. SETTING: A 16 bed surgical intensive care unit. SUBJECTS: All 267 men and 135 women admitted to the unit during the study period. INTERVENTIONS: None. MAIN OUTCOME MEASURES: APACHE II score (acute physiological, age, and chronic health evaluation), organ failure, septic shock, durations of intensive care unit and hospital stay, and intensive care unit and hospital mortality. RESULTS: No patient had AIDS. 52 patients were tested positive for HIV and 350 patients were tested negative. The two groups were similar in sex distribution but differed significantly in age, incidence of organ failure (37 (71%) v 171 (49%) patients), and incidence of septic shock (20 (38%) v 54 (15%)). After adjustment for age there were no differences in intensive care unit or hospital mortality or in the durations of stay in the intensive care unit or hospital. CONCLUSIONS: Morbidity was higher in HIV positive patients but there was no difference in mortality. In this patient population a positive HIV test result should not be a criterion for excluding a patient from intensive care.

APACHE↗
PubMed2002

Impact of highly active antiretroviral treatment on HIV seroincidence among men who have sex with men: San Francisco.

OBJECTIVES: This study assessed the countervailing effects on HIV incidence of highly active antiretroviral treatment (HAART) among San Francisco men who have sex with men (MSM). METHODS: Behavioral risk was determined on the basis of responses to cross-sectional community interviews. HIV incidence was assessed through application of an enzyme-linked immunoassay testing strategy. RESULTS: Use of HAART among MSM living with AIDS increased from 4% in 1995 to 54% in 1999. The percentage of MSM who reported both unprotected anal intercourse and multiple sexual partners increased from 24% in 1994 to 45% in 1999. The annual HIV incidence rate increased from 2.1% in 1996 to 4.2% in 1999 among MSM who sought anonymous HIV testing, and the rate was high (5.3%) but stable in a blinded survey of MSM seeking sexually transmitted disease services. CONCLUSIONS: Any decrease in per contact risk of HIV transmission due to HAART use appears to have been counterbalanced or overwhelmed by increases in the number of unsafe sexual episodes.

Adult↗
PubMed2001

A method to detect the incidence of hepatitis C infection among injecting drug users in Glasgow 1993-98.

OBJECTIVES: To determine the incidence of HCV infection in a selected population of Glasgow injectors during the mid-1990s, using a retrospective cohort design. METHODS: Unlinked anonymous anti-HCV testing was undertaken on serum residues collected from injecting drug users (IDUs) having two or more voluntary named HIV tests between 1993 and 1998. RESULTS: Seventy-seven percent (164/212) of IDUs had detectable HCV antibody in their first specimen collected. Of the 44 IDUs who were initially HCV seronegative and had a subsequent specimen available for testing, 11 (25%) seroconverted, giving an estimated incidence of 28.4 per 100 person-years (95% CI 15.7-51.2); the incidence of infection was greatest amongst older males. CONCLUSION: This study provides evidence of continuing transmission of HCV among Glasgow IDUs during an era of interventions to prevent the spread of bloodborne infections in this population and demonstrates the application of the unlinked anonymous testing approach to gauge incidence rather than prevalence of infection.

Adult↗
PubMed2002

HIV infection in men who have sex with men, New York City Department of Health sexually transmitted disease clinics, 1990-1999: a decade of serosurveillance finds that racial disparities and associations between HIV and gonorrhea persist.

BACKGROUND: Previous data indicating wide racial disparities in HIV seroprevalence, associations between sentinel sexually transmitted diseases (STDs) and HIV infection, and recent reports of STD outbreaks among men who have sex with men (MSM) have raised concerns that HIV may be resurgent among MSM. GOAL: To measure trends in HIV seroprevalence and describe racial disparities among MSM presenting to New York City Department of Health STD clinics, 1990-1999 (n = 4076). STUDY DESIGN: This blinded HIV-1 serosurvey used remnant serum originally drawn for routine serologic tests for syphilis. Demographic, risk factor, clinical and laboratory data were abstracted from clinic charts of patients whose medical records documented sexual contact with men or with both men and women ("bisexual" men). Data were matched to the specimens, and all personal identifiers were removed before testing. Patients were not interviewed. RESULTS: The sample was 41% black, 20% Hispanic, 31% white, and 9% of other or mixed race/ethnicity. Sixty-one percent of the patients were >30 years of age; 21% were > or = 40 years of age. One-third had sex with women as well as men. For 60%, laboratory-confirmed STD diagnosis was made on the serosurvey visit. Overall, HIV seroprevalence declined from 47% in 1990 to 18% in 1999 (P < 0.01). Seroprevalence declined from 34% to 11% among white men (n = 1250), from 47% to 19% among Hispanic men (n = 795), from 56% to 28% among black men (n = 1656), and from 43% to 14% among men who had sex with both men and women (n = 1447). Seroprevalence among MSM with gonorrhea (n = 507) declined but remained high (57-34%; P < 0.05). In contrast, seroprevalence among MSM with nongonococcal urethritis (n = 953) declined from 36% to 16% (P < 0.01), and seroprevalence among MSM who had no STD (n = 1650) dropped from 48% to 12% (P < 0.01). Gonorrhea was diagnosed almost twice as frequently among seropositive versus seronegative MSM (19% versus 10%; P < 0.05). Black MSM were not more or less likely to have been tested for HIV or to be diagnosed with acute STD than were MSM in the other-race/ethnicity group. Positive serostatus was associated with black race/ethnicity (odds ratio [OR], 2.5; 95% CI, 2.1-2.9), age >25 years (OR, 2.5; 95% CI, 1.9-3.1), and a diagnosis of gonorrhea (OR, 2.4; 95% CI, 2.0-2.8). Sixty percent of seropositive MSM knew their serostatus from confidential or anonymous HIV testing at this or a previous visit. Two thirds of the known seropositive men had a new STD diagnosed at the serosurvey visit. CONCLUSION: Seroprevalence in this racially diverse sample of MSM declined significantly during the study period. However, wide racial disparities in seroprevalence were observed that were not attributable to disparities in risk factors such as STD, bisexuality, or acceptance of HIV testing. This finding suggests that the observed differences may reflect racial differences in the background seroprevalences, such as those seen in all New York City serosurvey samples and the population-based AIDS case rates. High prevalence associated with gonorrhea and new STD in known seropositive men of any race suggests that continued efforts to control the incidence of STD, increased encouragement of MSM to accept HIV counseling and testing, and prevention-focused counseling of seropositive men are needed.

Adult↗
PubMed1991

Routine prenatal screening for HIV infection.

Guidelines in most developed countries for testing pregnant women for HIV infection recommend that screening should be directed to groups with acknowledged risk factors for infection. Our prospective study of HIV seroprevalence among 2724 pregnant women in an inner-city area of Baltimore, USA, showed that if these guidelines had been applied only 57% of HIV-seropositive women would have been detected. By offering counselling and HIV testing to all pregnant women, the detection rate was raised to 87%. We conclude that screening directed at women who admit risk factors is not effective in identifying HIV-infected women and that routine HIV screening should be offered to all pregnant women.

Adult↗
PubMed1998

Health benefits and risks of reporting HIV-infected individuals by name.

With more treatment options emerging for human immunodeficiency virus (HIV) infection, the policy of reporting HIV-infected individuals by name merits reevaluation. This paper reviews the benefits and risks of name reporting of persons infected with HIV. Public health departments have linked name reporting with medical referrals, risk reduction counseling, and partner notification programs. Yet some studies indicate that people are less likely to be tested for HIV infection when name reporting is implemented. Whether name reporting actually improves individual or public health, therefore justifying the increased risk of loss of confidentiality and possibly reduced testing rates, remains unknown. The lack of health outcome data on name reporting allows beliefs rather than facts to dominate debate about this policy. Before this practice is more widely adopted, a determination should be made as to whether the potential benefits of name reporting outweigh the risks.

AIDS Serodiagnosis↗
PubMedDate not supplied

Prevalence of antibodies against hepatitis C virus in the elderly: a seroepidemiological study in a nursing home and in an open population. The Collaborative Group.

BACKGROUND: The prevalence of antibodies against hepatitis C virus (anti-HCV) increases in the general population with advancing age. Several discrepancies exist in the epidemiology of HCV, however, when selected elderly population groups are tested. OBJECTIVE: To evaluate the HCV prevalence in two groups of elderly people living in the same geopgraphical area of northeast Italy, i.e., one including residents of a nursing home, the other including subjects living at home. METHODS: The overall sample included 496 subjects (mean age 79.31 +/- 8.9 years); 288 were in a nursing home, and 208 were living at home. Enrollment in the latter group was based on all subjects over 65 years old listed under the public health service in the same district. The overall rate of adhesion to the study was 90%. Each subject was administered an anonymous questionnaire testing sociodemographic data and risk factors for HCV infection. Serological tests included: anti-HCV and hepatitis B virus serum markers. Multiple logistic regression analysis was performed to evaluate risk factors for anti-HCV positivity. RESULTS: Anti-HCV positivity was found in 34 of 288 (11.8%) elderly in the nursing home and in 23 of 208 (11.1%) in the open population. When the total population was considered, females exhibited a significantly a higher prevalence of anti-HCV than males (13.4 vs. 7.5%, p < 0.05). In both males and females, the highers rate of anti-HCV prevalence was found among the 75- to 79-year-old subjects. A decline in anti-HCV prevalence was observed in the very old subjects (over 80 years of age). None of the anti-HCV-positive subjects was found to be coinfected with hepatitis B surface antigen. However, multiple logistic regression analysis identified the age group between 70 and 79 years, female gender, and positivity for antihepatitis B surface antigen and/or antihepatitis B core antigen as independent variables significantly associated with HCV prevalence. CONCLUSIONS: The prevalence of anti-HCV proved identical among elderly people living in the nursing home or at home, suggesting that nursing homes do not represent a risk factor for HCV infections; the significant association between HCV prevalence and antihepatitis B surface antigen and/or antihepatitis B core antigen positivity supports a common route of transmission of the two viruses; these findings would suggest that there was an epidemic of HCV infection during the Second World War and in the years immediately afterwards.

Age Distribution↗
PubMed2004

Guthrie test samples: is the problem solved?

Most babies born in New Zealand have a blood sample taken shortly after birth for the purposes of certain screening tests. The samples are retained indefinitely. This paper considers whether such samples are the property of the child and whether the present changes in the Health (National Cervical Screening Programme) Amendment Bill and the Code of Health and Disability Services Consumers' Rights of 1996 are sufficient to resolve the issues. The paper expresses concern about the delegation of decision-making in this area to ethics committees.

Anonymous Testing↗
PubMed1995

Apolipoprotein E and Alzheimer's disease: the implications of progress in molecular medicine.

We review the current status as well as the risks and benefits of a recently developed DNA test of risk for Alzheimer's disease: the apolipoprotein E genotype. While apolipoprotein E genotypes may indicate a degree of susceptibility, the gene is neither necessary nor sufficient to cause the disease; thus, many questions remain. Because risk prediction is not straightforward, practical issues related to the testing of complex diseases like Alzheimer's and to the ethical, legal, and social implications of genetic tests require careful consideration and unambiguous answers. The use of apolipoprotein E genotyping in patients with Alzheimer's disease should be limited to research centers, and additional studies are strongly recommended. Apolipoprotein E genotypes should not be available to third parties such as insurers or employers until genotypic risks are fully understood. National policies that encourage scientific investigation while maintaining individual privacy and limiting unnecessary access to genetic information should be immediately developed.

Alzheimer Disease↗
PubMed1992

Ethics, social forces, and politics in AIDS-related research: experience in planning and implementing a household HIV seroprevalence survey.

A controversial proposal for a survey of HIV infection in a probability sample of U.S. household residents as part of the government's surveillance of the AIDS epidemic provided a number of challenges to survey science. These were compounded by ethical concerns and social sensitivities surrounding the topic. Questions about the ability of a voluntary survey to produce an accurate national estimate of infection demanded rigorous study. In 1987, the Centers for Disease Control began planning field tests of a survey to obtain blood samples and information about respondents' sexual behavior and drug use. The authors were part of the team deployed by the National Center for Health Statistics that, with the contractor staff from Research Triangle Institute, conducted studies in Pittsburgh and Dallas, but only after much was learned about developing processes and procedures for dealing both with broad community concerns and with the interests of those gravely touched by the epidemic.

Advisory Committees↗
PubMed1993

A novel use of the link-file system for longitudinal studies of HIV infection: a practical solution to an ethical dilemma.

BACKGROUND: Longitudinal studies that collect sensitive data, such as test results for HIV antibodies, present difficult ethical problems for investigators. Personal identifiers are needed for longitudinal follow-up, but current regulations in the United States require that all subjects be informed of their HIV test results when identifiers are retained. Therefore, subjects who do not wish to learn their HIV status must be excluded from prospective research. Because these subjects may be at particularly high risk for HIV infection, this situation may lead to substantial bias. METHODS: We describe a new application of a methodology for blinding such studies, based on the link-file system used for protecting subjects' sensitive research data. This design enables investigators to hold each subject's HIV test result and survey data for multiple ascertainments over time while effectively severing any link between this information and the subject's identity. This objective is achieved by a process of sequential coding, using at least two coders who are not associated with the study. CONCLUSIONS: The method described in this paper permits investigators in the United States to perform important prospective epidemiologic studies while adhering to current regulations for the conduct of such investigations.

Anonymous Testing↗
PubMed2005

High-throughput gender determination using automated denaturant gel capillary electrophoresis.

Sex determination of anonymous samples is a requirement before analysis of DNA variation on X or Y chromosomes. Based on this, we designed a method for screening samples on different DNA capillary sequencing instruments with a sensitivity that is able to quantify sex chromosome abnormalities. The two different amelogenin alleles sited on the X and Y chromosomes were polymerase chain reaction amplified with the same set of primers and separated by denaturant capillary electrophoresis (DCE). Sex chromosome ratios could be reproducibly determined with a relative standard deviation of 8.7%, which is sufficient to distinguish a normal XY karyotype from an XYY karyotype associated with Klinefelter syndrome. Reconstruction experiments demonstrated sensitivity down to a simulated Y:X allelic ratio of 1:127 in all three instruments, enabling the prediction of sex chromosomal aneuploidies. When tested on anonymous pooled and single samples, DCE gave a good prediction of the male to female ratio in pools of 1000 blood donors. In conclusion, DCE is a simple and robust method for sex determination that can be readily performed on commercially available CE systems.

Alleles↗
PubMed1998

Genetic and biochemical screening for endocrine disease: II. Ethical issues.

The ability to test for specific genes conferring susceptibility to a variety of diseases has profound ethical implications for the way in which we care for patients. Legislators and health care insurers are scrambling to address the aspects of genetic screening that they believe fall within their purview. Critical to the development of appropriate societal regulations regarding genetic screening is a fundamental understanding of the ethical issues involved. A review of those concerns and the areas in which they interface with legal and insurance issues is the topic of this paper.

Anonymous Testing↗
PubMed2005

Molecular genetic confirmatory testing from newborn screening samples for the common African-American, Asian Indian, Southeast Asian, and Chinese beta-thalassemia mutations.

beta-Thalassemia is a serious health problem in the United States, especially in California, due to increased Asian immigration. Neonatal screening by using high-performance liquid chromatography (HPLC) or isoelectric focusing (IEF) may lead to confusion due to interactions of various hemoglobinopathies with beta-thalassemia. Our purpose was to develop single-tube multiplexed PCR assays using original neonatal screening specimens to identify the mutations responsible for beta-thalassemia in order to expedite diagnostic confirmation. Primers were designed for two to six common ethnic-specific mutations using the amplification refractory mutation system (ARMS). This multiplex ARMS approach was standardized using DNA samples with known mutations for beta-thalassemia in those of Asian (Southeast Asian, Chinese, and Asian Indian) and African-American descent. Specimens from African-American neonates were tested for two mutations (-88 and -29); Asian Indians for five mutations (IVSI-1, IVSI-5, codons (Cd) 41/42, Cd 8/9, and 619-bp deletion); Chinese, Taiwanese, and Southeast Asians for seven mutations (Cd 41/42, Cd 17, -28, IVSII-654, Cd 71/72, IVSI-5, and IVSI-1). We identified each of these beta-thalassemia mutations in multiplexed ARMS from positive control samples. We tested 25 anonymized dried blood specimens from neonates who had been diagnosed with beta-thalassemia and who also belonged to these ethnic groups. We detected a mutation specific to the neonate's ethnic group using the ARMS approach in nearly all specimens, and the results were confirmed by sequencing. Multiplexed ARMS for ethnic-specific beta-thalassemia mutations from the original newborn screening dried blood specimens is a rapid and efficient approach for diagnostic confirmation.

Asian People↗