Design, Implementation, and Evaluation at Entry of a Prospective Cohort Study of Homosexual and Bisexual HIV-1???Negative Men in Belo Horizonte, Brazil: Project Horizonte

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Abstract
Background:Symptoms associated with HIV infection are common among HIV seroconverters, but the acute retroviral syndrome (ARS) is a diagnostic challenge because of the absence of a sensitive and specific case definition. We conducted an analysis of HIV seroconverters in Projeto Praça Onze, a HIVNET HIV seroincidence study among homosexual men in Rio de Janeiro. Methods:Information from study subjects enrolled in Projeto Praça Onze who were documented HIV seroconverters were compared with nonseroconverters. At each semiannual study visit, participants were asked about HIV seroconversion symptoms and sexually transmitted diseases (STDs) during the preceding 6 months. All information was collected before the laboratory evaluation. A classification tree analysis was used to identify an ARS case definition, first using clinical information and then after including risk factor data for seroconversion in our cohort. Results:As of July 1998, 674 volunteers were enrolled and 34 of these seroconverted; information was available for 33 of these. Among the seroconverters, 11 (34%) denied any symptoms, and 22 (66%) reported one or more symptoms, the most common of which were fever (25% of seroconverters versus 7% of nonseroconverters; p <.01), night sweats (9% versus 2%, respectively; p = .05), incapacitating disease (ID) for ≥3 days (27% versus 7%, respectively; p < .001), and weight loss of ≥2 kg (21% versus 9%, respectively; p = .05). STDs were more common in seroconverters (gonorrhea: 9% versus 1%, respectively; p < .01 and condyloma: 9% versus 3%, respectively; p = .08). The first case definition was ID for >3 days, fever, pharyngitis, and myalgia (seroconverters, 3 of 32, versus nonseroconverters, 2 of 640). The second case definition was was ID for >3 days, anti-core hepatitis b-positive, and age <21 years (seroconverters: 6 of 32 versus nonseroconverters 4 of 640). The sensitivity and specificity for the first and second case definitions were: 9.4%, 99.4%, and 18.8%, 99.8%, respectively. Conclusions:Among HIV seroconverters, symptoms consistent with ARS were common. We were unable to identify a sensitive case definition that could be used as a screening tool. Although the clinical case definition was not validated, the specificity of our case definitions was high, suggesting that subjects within this HIV risk group who fulfill the case definition should be tested for HIV. Address correspondence and reprint requests to Mauro Schechter, AIDS Research Laboratory, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Av. Brig. Trompowsky, Ilha do Fundão, Rio de Janeiro, CEP 21941-590 Brazil; e-mail: [email protected] The views expressed in this article do not necessarily reflect those of Family Health International, National Institutes of Health, or Petrobrás SA. This study was presented in part at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, U.S.A., 1999. Manuscript received February 9, 2000; accepted June 9, 2000. © 2000 Lippincott Williams & Wilkins, Inc.

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