Dataset for: Developing HIV risk prediction tools in four African settings – User Guide

Permanent identifier

10.17037/DATA.00003540

Description

A quantitative dataset collected as part of an on-going HIV vaccine preparedness study “The PrEPVacc Registration Cohort”. The study was set up at sites in Masaka, Uganda; Durban, South Africa; Maputo, Mozambique; Mbeya and Dar es Salaam, Tanzania, to prepare a population of HIV negative individuals at risk of acquiring HIV for possible participation in the PrEPVacc HIV vaccine efficacy and pre-exposure prophylaxis trial.

It contains information on demographic, HIV risk behavioural characteristics, HIV prevalence at screening and incidence during follow up, among participants.

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.16 (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
• Instituto Nacional de Saúde – Maputo, Mozambique
• 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: November 2021

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 checking data consistency within individual CRFs.

The database has an audit trail functionality which is used to monitor timeliness and 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

We 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.

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/AIDS; HIV incidence; HIV prevalence; HIV risk score.

Language of written material

English

Project information

Creators

Associated roles

File description