Data for: Changes in self-reported risky sexual behaviour indicators among adults receiving regular risk reduction counselling and optional initiation of pre-exposure prophylaxis in an HIV vaccine preparedness study in Masaka, Uganda – User Guide

Permanent identifier - User Guide

10.17037/DATA.00003403

Description

A quantitative dataset collected as part of an on-going HIV vaccine preparedness study “The PrEPVacc Registration Cohort”. It contains information on demographic, HIV risk behavioural characteristics and PrEP uptake among participants. Responses cover participants from the Masaka registration cohort who completed at least one year of follow-up in the cohort.

Data collection methods

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.

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 collection in Masaka city, Uganda.

Key dates

Data collection period: July 2018 - December 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

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.

Ethics

Keywords

Risky sexual behaviour, HIV, pre-exposure prophylaxis, Risk reduction counselling.

Language of written material

English

Project information

Additional information

This dataset may be requested for research verification and health research use, subject to ethics approval being obtained. All requests are handled by the MRC / UVRI and LSHTM Uganda Research Unit.

Creators

Associated roles

File description