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

Persistent identifier

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.

Data access conditions

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.

Data collection methods

Study data was collected by trained designated staff and entered directly onto the appropriate Case Report Forms(CRFs) or in source documents.

Data analysis and preparation

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).

Geographic regions

Data was captured at the study sites below:

• Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine (MRC/UVRI and LSHTM) Uganda Research Unit’s clinical research site, Masaka, Uganda.
• South African Medical Research Council, Durban, South Africa
• National Institute for Medical Research - Mbeya Medical Research Centre, Mbeya, Tanzania
• Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

Key dates

• Start date: July 2018
• End of data capture: 31 Jan 2024

(Data entry and cleaning were still ongoing and were not expected to impact the conclusions presented in this paper).

Quality controls

Standardised CRFs were used to collect and record all quantitative data. Project staff were trained in principles of ICH-GCP. Project staff were also trained on the study database, completion of CRFs and data quality control procedures. The Open Clinica database was designed to quality control the data at entry have logic checks such as   validation of double data entry discrepancy checks through discrepancy note alerts, query key missing data, and check data consistency within individual CRFs.

The database has an audit trail functionality which is used to monitor timeliness of data entry as well as track records of data corrections/changes in the database. The data was reviewed, cleaned and managed by clinical study monitors and data managers using Stata data quality checking do files. Queries were routinely identified and forwarded to the study sites for resolution. Once raised to the sites, their resolution progress was monitored. 

Population

The registration cohort recruited individuals aged 18–45 years of age, HIV-negative, willing to provide locator information, available for follow-up, and considered to be at risk of HIV infection as per the following risk indicators: suspected/confirmed sexually transmitted infection (STI), unprotected sex with ≥2 partners, unprotected sex with a new partner in the past 3 months, or unprotected transactional sex (giving/receiving money/goods in exchange for sex) in the past month, among others.

The PrEPVacc trial inclusion and exclusion criteria can be found under ClinicalTrials.gov ID NCT04066881.

Privacy

At the sites, CRFs and source documents were kept in secure central locations. All computers were password controlled. All data was collected in a pseudo-anonymised format with every participant having a participant ID. No names were collected in the study database. For this dataset, participants have now also been assigned new PTIDs.

Ethics

Keywords

HIV; Pre-exposure prophylaxis; Sub-Saharan Africa; Active-controlled trials; Counterfactual placebo HIV incidence; Novel HIV trial designs.

Language of written material

English

Project information

Additional information

For the PrEPVacc trial, AIDSVAX® B/E vaccine is provided by Global Solutions for Infectious Diseases (GSID), USA. Truvada and Descovy are provided free of charge for participants participating in the PrEP trial by Gilead Inc. DNA-HIV-PT123 vaccine is provided by the EuroVacc Foundation. CN54gp140 formulated with MPLA adjuvant is provided by Imperial College London, UK. MVA-CMDR is provided by the Walter Reed Army Institute of Research (WRAIR), USA. This study is also made possible by the support of the American People through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through United States Agency for International Development (USAID). The contents of this publication are the sole responsibility of the PrEPVacc Team and do not necessarily reflect the views of PEPFAR, USAID, or the United States Government.

Creators

Associated roles

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