HIV Prevention Protocol for Women

The study protocol and informed consent documents were reviewed by the local ethics committees of the University of KwaZulu-Natal, the University of Cape Town, the University of the Witwatersrand in Johannesburg, and by the Prevention Sciences Review Committee (PSRC) of the Division of AIDS (DAIDS, National Institutes of Health, U.S.A.). The consent forms were translated into isiZulu and written informed consent is obtained at each stage of the study (screening, enrolment into HIV-negative cohort, enrolment into acute infection phase, and for sample storage). All women screened for participation, whether ultimately enrolled into the study cohort or not, receive HIV pre- and post-test counselling, risk reduction counselling, male and female condoms, access to clinical care, and treatment for sexually transmitted infections (STIs). HIV/STI risk reduction counselling, condom provision, and prevention education supplies are administered at each subsequent study visit. One-on-one counselling was provided by a non-governmental organization which offered the same service in the public sector in the region, to be consistent with the services in the region. Overcoming one of the key challenges to doing HIV-related work in this context [11] (link), participants who were HIV infected during the study were referred to the CAPRISA Antiretroviral Treatment (CAT) programme where they were offered ongoing care, and treatment for HIV when clinically eligible.