Risk-Reduction Counseling and Other Prevention and Treatment Services

Risk-Reduction Counseling and Other Prevention and Treatment Services

To assist participants in eliminating or reducing HIV risk behaviors, extensive counseling is provided at each study visit, and more often if needed. This interactive counseling has proven effective in reducing the risk of HIV and other STDs in multiple populations, including past participants of similar HIV prevention trials. Participants are also offered free condoms and STD testing and treatment to reduce their risk for HIV infection. Additionally, in Thailand, participating IDUs are offered follow-up in a methadone drug treatment program and receive bleach and instructions on how to use it to clean needles. Consistent with Thai government policy, sterile syringes are not provided, but are widely available in Thailand without a prescription and at low cost (one sterile syringe and one needle cost about 5 baht, or about $0.15).

While participants will likely be at lower risk as a result of these prevention services, some individuals will engage in behavior that places them at risk for HIV infection. To ensure that participants who are infected during the trial are quickly referred to the best available medical and psychosocial services, participants receive free rapid HIV testing at every visit. This regular HIV testing will also help guard against the development of drug-resistant virus, as the study drug will be immediately discontinued when infection is detected.

Participants who become infected receive confirmatory testing for infection, post-test risk-reduction and support counseling, and help enrolling in local HIV care programs. Both Thailand and Botswana have antiretroviral treatment and HIV care programs in place at minimal or no cost to patients.

Additionally, to help guide treatment decisions and to determine if prior exposure to tenofovir or tenofovir plus emtricitabine has any effect on the course of disease, initial testing is provided for viral load, CD4 count, and HIV drug resistance mutations. Participants are followed for an additional six months following infection to examine their immune and virologic response. Although study procedures ensure a very low risk of drug-resistant virus emerging, the initial HIV resistance testing will provide important data on the degree to which any resistance does occur.