Kansiime, S, Holm Hansen, C, Ruzagira, E, McCormack, S, Hayes, R, Dunn, D and PrEPVacc study team. 2024. Data set for: Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: the PrEPVacc trial. [Online]. London School of Hygiene & Tropical Medicine, London, United Kingdom. Available from: https://doi.org/10.17037/DATA.00004435.
Kansiime, S, Holm Hansen, C, Ruzagira, E, McCormack, S, Hayes, R, Dunn, D and PrEPVacc study team. Data set for: Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: the PrEPVacc trial [Internet]. London School of Hygiene & Tropical Medicine; 2024. Available from: https://doi.org/10.17037/DATA.00004435.
Kansiime, S, Holm Hansen, C, Ruzagira, E, McCormack, S, Hayes, R, Dunn, D and PrEPVacc study team (2024). Data set for: Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: the PrEPVacc trial. [Data Collection]. London School of Hygiene & Tropical Medicine, London, United Kingdom. https://doi.org/10.17037/DATA.00004435.
Description
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.
Additional information
This dataset may be requested for the purpose of research verification and use in academic research, subject to evidence of ethics approval being provided. Data applications are handled by the MRC / UVRI and LSHTM Uganda Research Unit, taking advice from the Research Ethics Committee as needed.
Description of data capture | 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). | ||||
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Data capture method | Questionnaire: Fixed form - Web-based | ||||
Data Collection Period |
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Date (Date published in a 3rd party system) | 25 November 2024 | ||||
Language(s) of written materials | English |
Data Creators | Kansiime, S, Holm Hansen, C, Ruzagira, E, McCormack, S, Hayes, R, Dunn, D and PrEPVacc study team |
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Associated roles | Mutonyi, G and Kakande, A |
LSHTM Faculty/Department | Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology & International Health (2023-) MRC/UVRI and LSHTM Uganda Research Unit |
Participating Institutions | MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda, London School of Hygiene & Tropical Medicine, London, United Kingdom, University College London, London, United Kingdom |
Funders |
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Date Deposited | 25 Nov 2024 16:05 |
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Last Modified | 25 Nov 2024 16:06 |
Publisher | London School of Hygiene & Tropical Medicine |
Downloads
Data / Code
Restricted to: Request access for all
Filename: Incidence_estimation_Regn_data.txt
Description: A pseudo-anonymised quantitative dataset collected as part of the PrEPVacc registration cohort and trial. EMBARGOED UNTIL 31 DEC 2024
Licence: Data Sharing Agreement
Content type: Dataset
File size: 139B
Mime-Type: text/plain
Documentation
Filename: Incidence_estimation_Regn_data_codebook.html
Description: Codebook for Incidence estimation Regn dataset
Content type: Textual content
File size: 9kB
Mime-Type: text/html
Filename: 4435_UserGuide.html
Description: User guide for Incidence estimation Regn dataset
Content type: Textual content
File size: 11kB
Mime-Type: text/html