Data set for: Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: the PrEPVacc trial

A compiled pseudo-anonymised quantitative dataset collected as part of the PrEPVacc registration cohort and trial. The registration cohort was set up to prepare a population of HIV negative individuals at risk of acquiring HIV for possible participation in the PrEPVacc phase IIB HIV prophylactic vaccine and pre-exposure prophylaxis trial. There are two components to this dataset, firstly the cohort dataset that was used to develop a regression model predicting HIV incidence. Secondly, a trial dataset with the participant characteristics that could be entered in the model and utilised for prediction of HIV incidence that could have occurred if participants in the active-controlled PrEP trial component had never been dispensed PrEP. The PrEPVacc trial was conducted at four study sites in Tanzania (2 sites), South Africa, and Uganda. This dataset is as of 31 Jan 2024. Study data was collected by trained designated staff and entered directly onto the appropriate Case Report Forms(CRFs) or in source documents. A study database was set up in OpenClinica, a web-based data management system and hosted at the MRC/UVRI clinical research centre. At each of the study sites, data was double entered by two separate data entry personnel. Data was entered as soon as possible (e.g. within one week) after a visit and routine data cleaning queries were raised and resolved. All data analysis was conducted in STATA V.18 (College Station, TX, US).