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18-01-2024 | Acquired Immune Deficiency Syndrome | Commentary

The City Clinic Cohort Study: Hepatitis B, HTLV-III/LAV, and CDC AIDS Project 24

Author: William W. Darrow

Published in: AIDS and Behavior | Issue 2/2024

Abstract

Anticipating the availability of a safe vaccine, scientists at the Center for Disease Control (CDC) planned for a multicenter study of the prevalence, incidence, and efficacy of an experimental vaccine for hepatitis B in 1977, conducted the study among homosexual male volunteers in five collaborating sexually transmitted infection (STI) clinics in the United States from April 1978 through 1980, and concluded that the candidate vaccine was highly efficacious in preventing infections with the hepatitis B virus. Then something completely unexpected and portentous happened. Some successfully vaccinated as well as other homosexual and bisexual men began to show signs and symptoms of a rare cancer, Kaposi’s sarcoma, and opportunistic infections typically associated with severe immunodeficiency. As early as October 1983, members of the Hepatitis B study cohort in San Francisco were invited to return to the city STI clinic for further examinations, testing, and confidential interviews about their sexual and other practices. CDC AIDS Project 24 was designed to help describe the natural history of AIDS, define risk factors, and predict future trends. It produced some of the earliest and most convincing scientific evidence about the seriousness and extent of the AIDS epidemic among homosexual and bisexual men in the United States. How the City Clinic Cohort Study came about and evolved is the focus of this commentary.

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Silverman MF. AIDS education and politics. In: Sepulvida J, Fineberg H, Mann J, editors. AIDS prevention through education: a world view. New York: Oxford University Press; 1993. p. 349–59.

Bayer R. Private acts, social consequences: AIDS and the politics of public health. New York: Free Press; 1989.

Ryder NB. The cohort as a concept in the study of social change. In: Mason WM, Fienberg SE, editors. Cohort analysis in social research. New York: Springer; 1985. p. 9–44. https://doi.org/10.1007/978-1-4613-8536-3_2.CrossRef

Shilts R. The mayor of Castro street: the life and times of Harvey Milk. New York: St. Martin’s Press; 1982.

Blumberg BS. Australia antigen and the biology of hepatitis B. Science. 1977;197(4298):17–25. https://doi.org/10.1126/science.325649.ADSCrossRefPubMed

Benenson AS, editor. Control of communicable diseases in man. 14th ed. Washington: American Public Health Association; 1975.

Blumberg BS. The hepatitis B virus. Public Health Rep. 1980;95(5):427–35.PubMedPubMedCentral

Hersh T, Melnick JL, Goyal RK, Hollinger FB. Nonparenteral transmission of viral hepatitis type B (Australia antigen-associated serum hepatitis). N Engl J Med. 1971;285(24):1363–4. https://doi.org/10.1056/NEJM197112092852408.CrossRefPubMed

Fulford KWM, Dane DS, Catterall RD, Woof R, Denning JV. Australia antigen and antibody among patients attending a clinic for sexually transmitted diseases. Lancet. 1973;301(7818):1470–3. https://doi.org/10.1016/S0140-6736(73)91810-2.CrossRef

10.

Jeffries DJ, James WH, Jefferiss FJ, MacLeod KG, Willcox RR. Australia (hepatitis-associated) antigen in patients attending a venereal disease clinic. Br Med J. 1973;2(5864):455–6. https://doi.org/10.1136/bmj.2.5864.455.CrossRefPubMedPubMedCentral

11.

Gerlich WH. Medical virology of hepatitis B: how it began and where we are now. Virol J. 2013;10:239. https://doi.org/10.1186/1743-422X-10-239.CrossRefPubMedPubMedCentral

12.

Coleman JC, Waugh M, Dayton R. Hepatitis B antigen and antibody in a male homosexual population. Br J Vener Dis. 1977;53(2):132–4. https://doi.org/10.1136/sti.53.2.132.CrossRefPubMedPubMedCentral

13.

Dietzman DE, Harnisch JP, Ray CG, Alexander ER, Holmes KK. Hepatitis B surface antigen (HBsAg) and antibody to HBsAg. Prevalence in homosexual and heterosexual men. JAMA. 1977;238(24):2625–6.CrossRefPubMed

14.

Lim KS, Wong VT, Fulford KW, Catterall RD, Briggs M, Dane DS. Role of sexual and non-sexual practices in the transmission of hepatitis B. Sex Transm Inf. 1977;53(3):190–2.CrossRef

15.

Szmuness W, Much I, Prince AM, et al. On the role of sexual behavior in the spread of hepatitis B infection. Ann Intern Med. 1975;83(4):489–95. https://doi.org/10.7326/0003-4819-83-4-489.CrossRefPubMed

16.

Hilleman MR, Buynak EB, Roehm RH, et al. Purified and inactivated human hepatitis B vaccine: progress report. Am J Med Sci. 1975;270:401–4.CrossRefPubMed

17.

Wiktor SZ. Viral hepatitis. In: Holmes KK, Bertozzi S, Bloom BR, Jha P, editors. Disease control priorities. Major infectious disease. Washington: World Bank; 2017.

18.

O’Malley PM. AIDS and the hepatitis B vaccine trial in San Francisco. In: The San Francisco AIDS oral history series--The AIDS epidemic in San Francisco: the response of community physicians, 1981–1984, Vol. II. Interview conducted by Sally Smith Hughes, Ph.D. in 1996, with an Introduction by Donald I. Abrams, M.D. Berkeley, Regional Oral History Office, The Bancroft Library, University of California; 2000. Available at: https://oac.cdlib.org/ark:/13030/kt30000449/. Accessed March 8, 2023.

19.

Center for Disease Control (CDC). QUESTIONNAIRE: HEPATITIS STUDY. Schedule A, Initial Visit, 1978. The global health chronicles. https://www.globalhealthchronicles.org/items/show/8045. Accessed June 16, 2023.

20.

Schreeder MT, Thompson SE, Hadler SC, et al. Hepatitis B in homosexual men: prevalence of infection and factors related to transmission. J Infect Dis. 1982;146(1):7–15. https://doi.org/10.1093/infdis/146.1.7.CrossRefPubMed

21.

Centers for Disease Control and Prevention. AIDS IN HBV COHORT: incidence and prevalence of hepatitis B in the City Clinic Cohort, July 1983. The global health chronicles. https://www.globalhealthchronicles.org/items/show/8111. Accessed July 20, 2023.

22.

Francis DP, Hadler SC, Thompson SE, et al. The prevention of hepatitis B with vaccine: report of the Centers for Disease Control multi-center efficacy trial among homosexual men. Ann Intern Med. 1982;97(3):362–6. https://doi.org/10.7326/0003-4819-97-3-362.CrossRefPubMed

23.

Krueger EA, Fish JN, Hammack PL, Lightfoot M, Bishop MD, Russell ST. Comparing national probability and community-based samples of sexual minority adults: implications and recommendations for sampling and measurement. Arch Sex Behav. 2020;49(5):1463–75. https://doi.org/10.1007/s10508-020-01724-9.CrossRefPubMedPubMedCentral

24.

Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980;303(15):833–41. https://doi.org/10.1056/NEJM198010093031501.CrossRefPubMed

25.

Szmuness W, Stevens CE, Zang EA, Harley EJ, Kellner A. A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report. Hepatology. 1981;1(5):377–85. https://doi.org/10.1002/hep.1840010502.CrossRefPubMed

26.

Centers for Disease Control (CDC). Update: acquired immunodeficiency syndrome in the San Francisco cohort study 1978–1985. MMWR Morb Mortal Wkly Rep. 1985;34(38):573–5.

27.

Hughes SS. Appendix A: AIDS chronology. In: The AIDS epidemic in San Francisco: The medical response, 1981–1984, Volume II. An oral history conducted in 1992. Berkeley, The Bancroft Library, University of California; 1996.

28.

Centers for Disease Control and Prevention (CDC). Pneumocystis pneumonia--Los Angeles. MMWR Morb Mortal Wkly Rep. 1981;30(21):250–2.

29.

Centers for Disease Control and Prevention. EMERGENCE OF KS/OI. Inaugural meeting minutes of the KSOI Task Force, June 22, 1981. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/6631. Accessed November 16, 2022.

30.

Centers for Disease Control and Prevention. HOMOSEXUAL BEHAVIORS AND RISKS. Comparison of Jay-Young Survey and Hepatitis Clinic Study Data. July 1, 1981. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8079. Accessed July 20, 2023.

31.

Darrow WW, Barrett D, Jay K, Young A. The gay report on sexually transmitted diseases. Am J Public Health. 1981;71(9):1004–11. https://doi.org/10.2105/ajph.71.9.1004.CrossRefPubMedPubMedCentral

32.

Centers for Disease Control and Prevention. VD CLINIC PATIENT: SAN FRANCISCO. Memorandum to Chairperson, KSOI Task Force, August 18, 1981. The Global Health Chronicles. https://globalhealthchronicles.org/items/show/8098. Accessed June 16, 2023.

33.

Centers for Disease Control and Prevention. DATA SUMMARY: 35 Interviews. Attachment A--Tabular Results of 35 Interviews with AIDS Patients in New York City, San Francisco, and Atlanta, July 15-Aug 15, 1981. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/6606. Accessed June 16, 2023.

34.

Jaffe HW, Choi K, Thomas PA, et al. National case-control study of Kaposi’s sarcoma and pneumocystis carinii pneumonia in homosexual men: Part 1. Epidemiologic results Ann Intern Med. 1983;99(2):145–51. https://doi.org/10.7326/0003-4819-99-2-145.CrossRefPubMed

35.

Rogers MF, Morens DM, Stewart JA, et al. National case-control study of Kaposi’s sarcoma and Pneumocystis carinii pneumonia in homosexual men: part 2. Laboratory results Ann Intern Med. 1983;99(2):151–8. https://doi.org/10.7326/0003-4819-99-2-151.CrossRefPubMed

36.

Darrow WW. Confronting AIDS in the early 1980s: biomedicine, public health, and the fourth estate. AIDS Behav. 2023;27(2):371–87. https://doi.org/10.1007/s10461-022-03976-z.MathSciNetCrossRefPubMed

37.

Francis DP. Defining AIDS and isolating the Human Immunodeficiency Virus (HIV), an oral history conducted in 1993 and 1994 by Sally Smith Hughes, Ph.D. In: The AIDS Epidemic in San Francisco: The Medical Response, 1981–1984, Volume IV. Regional Oral History Office, the Bancroft Library, University of California, Berkeley, 1997. Available at: https://oac.cdlib.org/view?docId=kt729005cr&brand=oac4&doc.view=entire_text Accessed August 21, 2023.

38.

Centers for Disease Control and Prevention. SAN FRANCISCO COHORT: Cooperative Agreement Development. Memorandum from Director, Center for Infectious Diseases, to Director, CDC, through: D. Rowe, Director, Procurement and Grants Office. May 5, 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8114. Accessed June 18, 2023.

39.

Centers for Disease Control and Prevention. COOPERATIVE AGREEMENT: San Francisco. Memorandum, “Implementation of Cooperative Agreement with the San Francisco City/County Health Department” from Chief, Epidemiology Section, AIDS Activity, to Director, AIDS Activity, May 26, 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8115. Accessed June 16, 2023.

40.

Centers for Disease Control and Prevention. SAN FRANCISCO COHORT: PHASE I. Protocol 639, Acquired Immune Deficiency Syndrome in a Cohort of Homosexual Male Clinic Patients and Draft Schedule A—Initial Visit, August 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8117. Accessed June 15, 2023.

41.

Centers for Disease Control and Prevention. PROTOCOL #639: Approval. Memorandum: Protocol 639, Acquired Immune Deficiency Syndrome in a Cohort of Homosexual Male Clinic Patients, September 23, 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8118. Accessed June 16, 2023.

42.

Centers for Disease Control and Prevention. AIDS PROJECT CODES. CDC AIDS Project 24: AIDS in a Cohort of Male Clinic Patients (SF), Darrow and Jaffe co-investigators; protocol pending, October 13, 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8107. Accessed June 16, 2023.

43.

Centers for Disease Control and Prevention. SAN FRANCISCO COHORT: AIDS Priorities Meeting. Overview of Hepatitis B Cohort Follow-Up Study and its Importance. November 10, 1983. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8119. Accessed June 17, 2023.

44.

Centers for Disease Control and Prevention. SAN FRANCISCO COHORT STUDY. CDC AIDS Priorities Meeting and the Priorities Assigned by Each Consultant to Each Project. November 10, 1983. The Global Health Chronicles. https://globalhealthchronicles.org/items/show/7983. Accessed July 21, 2023.

45.

Knight-Ridder Newspapers. 1,200 men part of AIDS study. Atlanta-Journal Constitution. October 2, 1983:11A.

46.

Centers for Disease Control and Prevention. SAN FRANCISCO CITY CLINIC COHORT: UPDATE. Memorandum from Research Sociologist to Director, AIDS Program, CDC Project 24: Plans for Further Analyses. February 1, 1984. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8120. Accessed July 20, 2023.

47.

Jaffe HW, Darrow WW, Echenberg DF, et al. The acquired immunodeficiency syndrome in a cohort of homosexual men. A six-year follow-up study. Ann Intern Med. 1985;103(2):210–4. https://doi.org/10.7326/0003-4819-103-2-210.CrossRefPubMed

48.

Jaffe HW, Feorino PM, Darrow WW, et al. Persistent infection with human T-lymphotropic virus type III/lymphadenopathy-associated virus in apparently healthy homosexual men. Ann Intern Med. 1985;102(5):627–8. https://doi.org/10.7326/0003-4819-102-5-627.CrossRefPubMed

49.

Nicholson JK, McDougal JS, Jaffe HW, et al. Exposure to human T-lymphotropic virus type III/lymphadenopathy-associated virus and immunologic abnormalities in asymptomatic homosexual men. Ann Intern Med. 1985;103(1):37–42. https://doi.org/10.7326/0003-4819-103-1-37.CrossRefPubMed

50.

Centers for Disease Control and Prevention. Revision of the case definition of acquired immunodeficiency syndrome for national reporting–United States. MMWR Morb Mortal Wkly Rep. 1985;34(25):373–5.

51.

Mason JO. Public Health Service plan for the prevention and control of acquired immune deficiency syndrome (AIDS). Public Health Rep. 1985;100(6):453–5.

52.

Silverman MF. The Bathhouse Crisis, 1983–1984. The San Francisco AIDS Oral History Series--The AIDS Epidemic in San Francisco: The Medical Response, 1981–1984: Volume I. Interviews conducted by Sally Smith Hughes, Ph. D., in 1992 and 1993 with an Introduction by James Chin, M.D., M.P.H. Available at: https://oac.cdlib.org/ark:/13030/kt2m3n98v1/. Accessed March 8, 2023.

53.

Centers for Disease Control (CDC). Antibodies to a retrovirus etiologically associated with acquired immunodeficiency syndrome (AIDS) in populations with increased incidences of the syndrome. MMWR Morb Mortal Wkly Rep. 1984;33(27):377–9.

54.

Darrow WW, Echenberg DF, Jaffe HW, et al. Risk factors for human immunodeficiency virus (HIV) infections in homosexual men. Am J Public Health. 1987;77(4):479–83. https://doi.org/10.2105/ajph.77.4.479.CrossRefPubMedPubMedCentral

55.

Darrow WW, Rutherford GW III. How safe is sex? (reply to Kristal). Am J Public Health. 1988;78(1):91–2.CrossRefPubMedCentral

56.

Centers for Disease Control and Prevention. SAN FRANCISCO: TRIP REPORT. Assistant to the Chief for Behavioral Studies to Director, AIDS Program, CDC Project 24, August 10–15, 1984. The Global Health Chronicles. https://www.globalhealthchronicles.org/items/show/8229. Accessed July 20, 2023.

57.

Byers RH Jr, Morgan WM, Darrow WW, et al. Estimating AIDS infection rates in the San Francisco cohort. AIDS. 1988;2:207–10.PubMed

Title: The City Clinic Cohort Study: Hepatitis B, HTLV-III/LAV, and CDC AIDS Project 24
Author: William W. Darrow
Publication date: 18-01-2024
Publisher: Springer US
Keywords: Acquired Immune Deficiency Syndrome
Hepatitis B
Human Immunodeficiency Virus
Public Health
Published in: AIDS and Behavior / Issue 2/2024
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI: https://doi.org/10.1007/s10461-023-04187-w

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