Testing Public Health Ethics: Why the CDC's HIV Screening Recommendations May Violate the Least Infringement Principle

Childress J. F. Faden R. R. Gaare R. D. Gostin L. O. Kahn J. Bonnie R. J. Kass N. E. Mastroianni A. C. Moreno J. D. Nieburg P. , “Public Health Ethics: Mapping the Terrain,” Journal of Law, Medicine & Ethics 30, no. 1 (2002): 169–177, at 172; Upshur R. E. G. , “Principles for the Justification of Public Health Intervention,” Canadian Journal of Public Health 93, no. 2 (2002): 101–103, at 102; Gostin L. O. , Public Health Law: Power, Duty, Restraint, 2nd ed. (Berkeley: University of California Press, 2008): at 68.

Id. ( Childress ), supra note 1, at 173.

Id., at 170–171.

The distinction between “testing” and “screening” is not important for our analysis. We tend to use the term “screening” when referring to policies aimed at populations and “testing” when discussing individual patients and rates of uptake, but the two terms are, for our purposes, interchangeable.

Branson B. M. Handsfield H. H. Lampe M. A. Janssen R. S. Taylor A. W. Lyss S. B. Clark J. E. , “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings,” Morbidity and Mortality Weekly Reports 55, no. RR14 (2006): 1–17.

Bartlett J. G. Branson B. M. Fenton K. Hauschild B. C. Miller V. Mayer K. H. , “Opt-Out Testing for Human Immunodeficiency Virus in the United States: Progress and Challenges,” JAMA 300, no. 8 (2008): 945–951.

See Branson , supra note 5.

Id.

Id., at 8.

Gostin L. O. , “HIV Screening in Health Care Settings: Public Health and Civil Liberties in Conflict?” JAMA 296, no. 16 (2006): 2023–2025, at 2025.

Centers for Disease Control, “HIV Testing among Pregnant Women: United States and Canada, 1998 – 2001,” Morbidity and Mortality Weekly Reports 51, no. 45 (2002): 1013–1016.

See, e.g., Centers for Disease Control, Module 6: HIV Testing and Counseling for PMTCT,” at Module 6–20, available at <http://www.cdc.gov/globalaids/Resources/pmtct-care/docs/TM/Module_6TM.pdf> (last visited March 16, 2011); National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India, Operational Guidelines for Integrated Counseling and Testing Centres , July 2007, at 16, available at <http://www.nacoonline.org/upload/Final%20Publications/Operational%20Guidelines%20for%20Integrated%20Counseling%20and%20Testing%20Centres.pdf> (last visited March 15, 2011).

See, e.g., id. (Centers for Disease Control); Cohan D. Gomez E. Greenberg M. Washington S. Charlebois E. D. , “Patient Perspectives with Abbreviated versus Standard Pre-test Counseling in the Prenatal Setting: A Randomized-Control, Non-inferiority Trial,” PLoS One 4, no. 4 (2009): E5166.

See, e.g., National AIDS Control Organization, supra note 12, at 16; id. ( Cohan ).

The concept of a “substantially autonomous” decision is borrowed from Faden and Beauchamp's “A History and Theory of Informed Consent.” Faden and Beauchamp do not specifically define what information must be understood in order for a decision to be “substantially autonomous,” but they do argue that substantially autonomous decisions require some level of understanding of the foreseeable consequences of a decision. Faden R. Beauchamp T. L. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986): At 237–240, 248–255.

World Health Organization and the Joint United Nations Programme on HIV/AIDS, “Guidance on Provider-Initiated Testing and Counseling in Health Facilities,” 2007, at 9, available at <http://whqlibdoc.who.int/publications/2007/9789241595568_eng.pdf> (last visited March 16, 2011).

Bayer R. Edington C. , “HIV Testing, Human Rights, and Global AIDS Policy: Exceptionalism and Its Discontents,” Journal of Health Politics, Policy and Law 34, no. 3 (2009): 301–323, at 305.

See Branson , supra note 5, at 5.

See Centers for Disease Control, supra note 11; Branson B. M. Lee J. H. Mitchell B. Nolt B. Robbins A. Thomas M. C. , “Targeted Opt-In vs. Routine Opt-Out HIV Testing in STD Clinics,” Abstract, Presented at the 13th meeting of the International Society for Sexually Transmitted Diseases Research, Denver, Colorado, July 11–14, 1999; Breese P. Burman W. Shlay J. Guinn D. , “The Effectiveness of a Verbal Opt-Out System for Human Immunodeficiency Virus Xcreening during Pregnancy,” Obstetrics and Gynecology 104, no. 1 (2004): 134–137; Jayaraman G. C. Preiksaitis J. K. Larke B. , “Mandatory Reporting of HIV Infection and Opt-Out Prenatal Screening for HIV Infection: Effect on Testing Rates,” Canadian Medical Association Journal 168, no. 6 (2003): 679–682; Perez F. Zvandaziva C. Engelsmann B. Dabis F. , “Acceptability of Routine HIV Testing (‘Opt-Out’) in Antenatal Services in Two Rural Districts of Zimbabwe,” Journal of Acquired Immune Deficiency Syndromes 41, no. 4 (2006): 514–520; Stanley B. Fraser J. Cox N. H. , “Uptake of HIV Screening in Genitourinary Medicine after Change to ‘Opt-Out’ Consent,” BMJ 326, no. 7400 (2003): 1174; Simpson W. M. Johnstone F. D. Goldberg D. J. Gormley S. M. Hart G. J. , “Antenatal HIV Testing: Assessment of a Routine Voluntary Approach,” BMJ 318, no. 7199 (1999): 1660–1661; Stringer E. M. Stringer J. S. Cliver S. P. Goldenberg R. L. Goepfert A. R. , “Evaluation of a New Testing Policy for Human Immunodeficiency Virus to Improve Screening Rates,” Obstetrics and Gynecology 98, no. 6 (2001): 1104–1108.

See id. ( Branson ); id. ( Breese ), at 135; id. ( Perez ), at 515, 518; id. ( Stanley ), at 1174.

See Stringer , supra note 19.

See Breese , supra note 19.

See Stringer , supra note 19.

See Branson , supra note 19; Stanley , supra note 19.

See Cohan , supra note 13; Yudin M. H. Moravac C. Shah R. R. , “Influence of an ‘Opt-Out’ Test Strategy and Patient Factors on Human Immunodeficiency Virus Screening in Pregnancy,” Obstetrics and Gynecology 110, no. 1 (2007): 81–86; Manzi M. Zachariah R. Teck R. Buhendwa L. Kazima J. Bakali E. Firmenich P. Humblet P. , “High Acceptability of Voluntary Counselling and HIV-Testing but Unacceptable Loss to Follow Up in a Prevention of Mother-to-Child HIV Transmission Programme in Rural Malawi: Scaling-Up Requires a Different Way of Acting,” Tropical Medicine and International Health 10, no. 12 (2005): 1242–1250; Malyuta R. Newell M. L. Ostergren M. Thorne C. Zhilka N. , “Prevention of Mother-to-Child Transmission of HIV Infection: Ukraine Experience to Date,” European Journal of Public Health 16, no. 2 (2006): 123–127.

Id. ( Yudin ), at 82.

See Manzi , supra note 25, at 1243.

See Cohan , supra note 13; Malyuta , supra note 25.

See Cohan , supra note 13.

Surprisingly, the researchers concluded that their results supported adoption of an abbreviated approach to pretest counseling despite the fact that there was no statistical difference in testing uptake or decisional conflict between the two groups and despite the fact that women who received standard pretest counseling had significantly higher mean knowledge scores compared to women who received only abbreviated counseling. See Cohan , supra note 13.

See Malyuta , supra note 25, at 124.

See Perez , supra note 19; Simpson , supra note 19.

See Branson , supra note 5, at 5.

See Perez , supra note 19.

See Simpson , supra note 19; Simpson W. M. Johnstone F. D. Boyd F. M. , “Uptake and Acceptability of Antenatal HIV Testing: Randomised Controlled Trial of Different Methods of offering the Test,” BMJ 316, no. 7127 (1998): 262–267.

In fact, if anything, the first phase of the study suggests no correlation between the amount of information patients are given and their anxiety levels. During the first phase, patients were randomized to four different opt-in groups, in which HIV testing was offered to all patients, and one control group, in which testing was not offered. None of the groups was given pretest counseling, but the four treatment groups did differ in the amount of information they received. Moreover, in contrast to the CDC recommendations, patients in two of the groups were informed about the potential disadvantages of being tested for HIV. The researchers did not find any significant differences in testing uptake or patient anxiety based on the amount of information patients received. See Simpson , supra note 35.

See Simpson , supra note 35, at 263.

See Simpson , supra note 19.

Ekwueme D. U. Pinkerton S. D. Holtgrave D. R. Branson B. M. , “Cost Comparison of Three HIV Counseling and Testing Technologies,” American Journal of Preventive Medicine 25, no. 2 (2003): 112–121; Farnham P. G. Gorsky R. D. Holtgrave D. R. Jones W. K. Guinan M. E. , “Counseling and Testing for HIV Prevention: Costs, Effects, and Cost-Effectiveness of More Rapid Screening Tests,” Public Health Reports 111, no. 1 (1996): 44–54.

Holtgrave D. R. , “Costs and Consequences of the US Centers for Disease Control and Prevention's Recommendations for Opt-Out HIV Testing,” PLoS Medicine 4, no. 6 (2007): 1011–1017.

Frith L. , “HIV Testing and Informed Consent,” Journal of Medical Ethics 31, no. 12 (2005): 699–700; Beauchamp T. L. Childress J. F. , Principles of Biomedical Ethics, 6th ed. (New York: Oxford University Press, 2009): at 107.

See Gostin , supra note 10.

Armstrong R. , “Mandatory HIV Testing in Pregnancy: Is There Ever a Time?” Developing World Bioethics 8, no. 1 (2008): 1–10, at 3.

Herek G. M. Capitanio J. P. Widaman K. F. , “HIV-Related Stigma and Knowledge in the United States: Prevalence and Trends, 1991–1999,” American Journal of Public Health 92, no. 3 (2002): 371–377; Mahajan A. P. Sayles J. N. Patel V. A. Remien R. H. Ortiz D. Szekeres G. Coates T. J. , “Stigma in the HIV/AIDS Epidemic: A Review of the Literature and Recommendations for the Way Forward,” AIDS 22, no. 2, Supp. (2008): S67–S79.

Schuster M. A. Collins R. Cunningham W. E. Morton S. C. Zierler S. Wong M. Tu W. Kanouse D. E. , “Perceived Discrimination in Clinical Care in a Nationally Representative Sample of HIV-Infected Adults Receiving Health Care,” Journal of General Internal Medicine 20, no. 9 (2005): 807–813; Elford J. Fowzia I. Bukutu C. Anderson J. , “HIV-Related Discrimination Reported by People Living with HIV in London, UK,” AIDS and Behavior 12, no. 2 (2007): 255–264.

Ahmed A. Hanssens C. Kelly B. , “Protecting HIV-Positive Women's Human Rights: Recommendations for the United States National HIV/AIDS Strategy,” Reproductive Health Matters 17, no. 34 (2009): 127–133.

Zierler S. Cunningham W. E. Andersen R. Shapiro M. F. Bozzette S. A. Nakazono T. Morton S. Crystal S. Stein M. Turner B. St. Clair P. , “Violence Victimization after HIV Infection in a US Probability Sample of Adult Patients in Primary Care,” American Journal of Public Health 90, no. 2 (2000): 208–215.

Lo B. Wolf L. Sengupta S. , “Ethical Issues in Early Detection of HIV Infection to Reduce Vertical Transmission,” Journal of Acquired Immune Deficiency Syndromes 25, no. 2, Supp. (2000): S136–S143; Bayer R. , “Changing the Paradigm for HIV Testing - The End of Exceptionalism,” New England Journal of Medicine 355, no. 7 (2006): 647–649.

Id. ( Lo ), at 132.

Keane V. Hammond G. Keane H. Hewitt J. , “Quantitative Evaluation of Counseling Associated with HIV Testing,” Southeast Asian Journal Tropical Medicine Public Health 36, no. 1 (2005): 228–232.

De Rosa C. Marks G. , “Preventive Counseling of HIV-Positive Men and Self-Disclosure of Status to Sex Partners: New Opportunities for Prevention,” Health Psychology 17, no. 3 (1998): 224–231.

See Gostin , supra note 1, at 141–142.

See Childress , supra note 1, at 172.

See Gostin , supra note 1, at 70–71.

See Branson , supra note 5, at 5.