Comprehensive Prevention Services for Subjects

At every scheduled visit, subjects received a comprehensive package of prevention services, including HIV testing, risk-reduction counseling, condoms, and diagnosis and treatment of symptomatic sexually transmitted infections, including gonorrhea and chlamydia urethritis, syphilis, and herpes simplex virus type 2 (HSV-2). In addition, at 24-week intervals, subjects were screened for asymptomatic urethritis, syphilis, antibodies to HSV-2, and genital warts and ulcers; treatment was provided when indicated. Sexual partners were offered treatment of sexually transmitted infections that were diagnosed in the subject. Subjects were linked to local prevention and treatment services when required to receive standard-of-care services. All subjects were instructed to protect themselves from HIV with conventional methods, since they were unaware of their study-group assignment. Subjects who reported a recent unprotected exposure to an HIV-infected partner were referred for postexposure prophylaxis (at sites where such therapy was available), and the administration of a study drug was temporarily suspended. Vaccination against hepatitis B virus (HBV) was offered to all susceptible subjects.

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Grant R.M., Lama J.R., Anderson P.L., McMahan V., Liu A.Y., Vargas L., Goicochea P., Casapía M., Guanira-Carranza J.V., Ramirez-Cardich M.E., Montoya-Herrera O., Fernández T., Veloso V.G., Buchbinder S.P., Chariyalertsak S., Schechter M., Bekker L.G., Mayer K.H., Kallás E.G., Amico K.R., Mulligan K., Bushman L.R., Hance R.J., Ganoza C., Defechereux P., Postle B., Wang F., McConnell J.J., Zheng J.H., Lee J., Rooney J.F., Jaffe H.S., Martinez A.I., Burns D.N, & Glidden D.V. (2010). Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. The New England journal of medicine, 363(27), 2587-2599.

Publication 2010

Antibodies Chlamydia Condoms Genital warts Gonorrhea Hepatitis b virus Herpes simplex virus type 2 Postexposure prophylaxis Sexual partners Sexually transmitted infections Syphilis Therapy Ulcers Urethritis Vaccination

Corresponding Organization :

Other organizations : University of California, San Francisco, Institute of Virology of the Slovak Academy of Sciences, EsSALUD, Asociación Civil Impacta Salud y Educación, University of Colorado Denver, San Francisco Department of Public Health, Asociación para la Conservación de la Cuenca Amazónica, Instituto Ecuatoriano de Enfermedades Digestivas, Instituto Evandro Chagas, Fundação Oswaldo Cruz, Chiang Mai University, Universidade Federal do Rio de Janeiro, Desmond Tutu HIV Foundation, University of Cape Town, Fenway Health, Brown University, Providence College, Universidade de São Paulo, University of Connecticut, Brighton Hospital, Gilead Sciences (United States), National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Variable analysis

independent variables

Prevention services package (HIV testing, risk-reduction counseling, condoms, diagnosis and treatment of sexually transmitted infections)
Screening for asymptomatic infections (urethritis, syphilis, HSV-2 antibodies, genital warts and ulcers) at 24-week intervals

dependent variables

Incidence of HIV infection
Diagnosis and treatment of sexually transmitted infections in subjects and their partners

control variables

All subjects were instructed to protect themselves from HIV with conventional methods, since they were unaware of their study-group assignment
Subjects who reported a recent unprotected exposure to an HIV-infected partner were referred for postexposure prophylaxis (at sites where such therapy was available), and the administration of a study drug was temporarily suspended
Vaccination against hepatitis B virus (HBV) was offered to all susceptible subjects

controls

Negative control: Subjects who were unaware of their study-group assignment and instructed to protect themselves from HIV with conventional methods
Positive control: Subjects who reported a recent unprotected exposure to an HIV-infected partner and were referred for postexposure prophylaxis

Annotations

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