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

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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.

Resumen

Anticipando la disponibilidad de una vacuna segura, los científicos del Centro para el Control de Enfermedades (CDC) planearon un estudio multicéntrico sobre la prevalencia, incidencia y eficacia de una vacuna experimental contra la hepatitis B en 1977; realizaron el estudio entre voluntarios varones homosexuales en cinco colaboraron con clínicas de infecciones de transmisión sexual (ITS) en los Estados Unidos desde abril de 1978 hasta 1980, y concluyeron que la vacuna candidata era muy eficaz para prevenir infecciones por el virus de la hepatitis B. Entonces sucedió algo completamente inesperado y portentoso. Algunos hombres vacunados con éxito, así como otros hombres homosexuales y bisexuales, comenzaron a mostrar signos y síntomas de un cáncer poco común, el sarcoma de Kaposi, e infecciones oportunistas típicamente asociadas con una inmunodeficiencia grave. Ya en octubre de 1983, se invitó a los miembros de la cohorte del estudio de la hepatitis B en San Francisco a regresar a la clínica de ITS de la ciudad para realizar más exámenes, pruebas y entrevistas confidenciales sobre sus prácticas sexuales y de otro tipo. El Proyecto 24 del CDC sobre SIDA fue diseñado para ayudar a describir la historia natural del SIDA, definir factores de riesgo y predecir tendencias futuras. Produjo algunas de las primeras y más convincentes pruebas científicas sobre la gravedad y el alcance de la epidemia de SIDA entre los hombres homosexuales y bisexuales en los Estados Unidos. El tema central de este comentario es cómo surgió y evolucionó el estudio de cohorte de City Clinic.

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Acknowledgements

I gratefully acknowledge and thank Torsten Bodecker, Erwin Braff, Jack Campbell, Selma Dritz, Doug Franks, Michael Frigo, and, especially, Paul O’Malley, of the San Francisco City and County Health Department for their assistance in reestablishing and carrying out socio-epidemiologic studies of AIDS in the City Clinic Cohort in the 1980s. Jim Wylie of the Survey Research Center at the University of California, Berkeley, was a helpful colleague willing to share data and good ideas. Bob Byers, Jerry Gentry, Fred Ingram, Harold Jaffe, Mitzi Mays, Ann Rumph, Charles Schable, Jean Smith, and Grady Waters were reliable coworkers at headquarters in Atlanta who contributed in various ways to the successful implementation of CDC AIDS Project 24. Doctoral student Sarah Suarez, Special Collections Department Head Althea “Vicki” Silvera and her very talented daughter, Megan, and Digital Archivist Rhia Rae of Florida International University helped me identify and recover original materials and manage the “Bill Darrow Collection in Miami.” Helene Sharon Bednarsh, Director of the HIV Dental Program for the Boston Public Health Commission; Andy Ruffner, the former Director of Education for the World AIDS Museum and Educational Center, and Paul O’Malley kindly agreed to critique earlier drafts; they provided me with excellent suggestions for improvement. Dr. Vicky Vazquez-Barrios translated my abstract from English into Spanish.

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  1. Professor Emeritus, Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, 33199, USA

    William W. Darrow

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Darrow, W.W. The City Clinic Cohort Study: Hepatitis B, HTLV-III/LAV, and CDC AIDS Project 24. AIDS Behav 28, 377–392 (2024). https://doi.org/10.1007/s10461-023-04187-w

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