Data for: “Loss to follow-up and associated factors in an HIV vaccine preparedness cohort study in Masaka, Uganda” - User Guide

Permanent identifier

https://doi.org/10.17037/DATA.00002915

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 Tanzania, Mozambique, South Africa, and Uganda to prepare a population of HIV negative individuals at risk of acquiring HIV for possible participation in the PrEPVacc HIV vaccine efficacy trial.  In Uganda, the study is conducted at the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine (MRC/UVRI and LSHTM) Uganda Research Unit’s clinical research site in Masaka city, Masaka district. This dataset only includes information from the Masaka registration cohort collected between July 2018 and March 2021. It contains information on demographic, HIV risk behavioural characteristics and study schedule adherence data/ LTFU data. Participants were considered LTFU if they missed two or more consecutive scheduled study visits and failed to attend further study visits after at least three documented attempts.

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 the site, 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.15.

Geographic regions

Data was captured at the 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 in Masaka city, Masaka district.

Key dates

• Data collection time period July 2018 - 1 March 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, 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

The type of participants contained within the data, e.g. human population with a specific condition, living in a specific region. We recruited individuals aged 18–45 years of age, HIV-negative, willing to provide locator information, available for follow-up, and have at least one of the following HIV 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.

Privacy

At the site, CRFs and source documents were kept in a secure central location. 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.

Data prepared for sharing has been fully anonymised prior to submission.

Ethics

Keywords

HIV prevention, loss to follow up, HIV prevention studies

Language of written material

English

Project information

Creators

Associated roles

File description