The Voluntary HIV-1 Counseling and Testing Efficacy Study: Design and Methods

While HIV counseling and testing has been promoted as potentially effective for prevention, few controlled studies have been conducted. The Voluntary HIV Counseling and Testing Efficacy Study was a randomized clinical trial of the effectiveness of HIV counseling and testing in reducing sexual risk behavior in three developing countries: Tanzania, Kenya, and Trinidad. The trial will provide crucial information regarding the effectiveness, cost, and consequences of HIV counseling and testing for prevention. This paper describes the design and methods of the Voluntary HIV Counseling and Testing Efficacy Study. Following a discussion of the study objectives, the design and methods of the study are presented. Recruitment, consent, randomization, intervention, assessment, follow-up, training, and quality assurance procedures are described. Issues raised in the design and anticipated in the interpretation of the study outcomes are discussed, as well as potential policy and service delivery implications of the study findings.