What was the Registration Cohort?
From July 2018 to October 2022, the study enrolled participants in what is called the Registration Cohort (in research terms, an ‘observational study’).
No drugs are tested by the Registration Cohort but members are simply tested for HIV and this information is important to help the study researchers get a better idea of the HIV incidence rate in the community around each site.
The cohort will also support promotional and engagement work with the community to inform them about the PrEPVacc trial, about HIV vaccine development and Phase III trials more generally, and about PrEP and the latest information on HIV.
Why was a Registration Cohort needed?
We have four reasons for enrolling people in the Registration Cohort:
Firstly to identify, recruit, and follow-up a cohort of male and female HIV-negative volunteers at high risk of HIV infection who may be prepared to take part in the PrEPVacc trial.
Secondly, to be able to estimate the incidence of HIV infection in the study volunteers. This is a key bit of information to allow the researchers to be able to calculate the effect of PrEP in the trial.
Thirdly to learn about people’s knowledge, perceptions, uptake of and adherence to PrEP (where it is available) around the sites.
Fourthly, to seek people’s help in developing and refining key messages about HIV vaccines and PrEP as well as tools for conveying these messages.