Good participatory practice guidelines for biomedical HIV prevention trials

UNAIDS guidelines.

These Good Participatory Practice guidelines aim to provide systematic guidance on the roles and responsibilities of entities funding and conducting biomedical HIV prevention trials towards participants and their communities. Such entities include investigators, research staff, pharmaceutical industry sponsors, foundations, governmentsupported research networks, non-governmental research sponsors, and all others involved in designing, financing, and executing clinical trials research. The implementation of these guidelines would be facilitated by the inclusion of individuals on the research team who are trained in community literacy and skilled in effective and appropriate community mobilisation. The trials in question test interventions and products for reducing HIV risk such as vaccines, microbicides, oral chemoprophylaxis, vaginal barrier methods, herpes simplex virus-2 (HSV-2) suppression or treatment, index patient treatment, and other strategies. They also can include implementation trials of biomedical interventions such as male circumcision which have been found to be effective. (adapted from the author)