ICECREAM

Municipality of Amsterdam

This study focuses on reducing the risk of hepatitis C reinfections.

Last change on 15th of January 2025, at 13:19 (CET) | Publication Standard 1.0

• Publication category: Impactful algorithms
• Impact assessment: DPIA
• Status: In use

General information

Theme

Education and Science

Begin date

01-18

End date

01-26

Contact information

[e-mail]

Link to publication website

https://icecreamstudy.nl/

Responsible use

Goal and impact

The aim of the behavioural intervention study is to reduce sexual risk behaviour and the risk of contracting hepatitis C virus (HCV) reinfection in men who have sex with men who have had HCV infection. The studyevaluates the extent to which two interventions, separately and combined, have a beneficial impact on risk behaviour. The duration of the study is 2.5 to 3 years.

An umbrella website is being developed for the study. Participants will receive questionnaires and, depending on the intervention study group they are randomly assigned to, will be given access to the online behavioural intervention, testing intervention or both interventions

Considerations

Field not filled in.

Human intervention

Researchers can download research data during the study. The data are entered into the GGD database by a coordinating researcher.

Risk management

The study did an abbreviated information security and privacy risk analysis, in which the questionnaires were reviewed for availability, integrity and confidentiality.

This resulted in the following opinion :

The scores on the various aspects of the BIV rating (Availability, Integrity and Confidentiality) and Personal Data indicate that:

• The Availability aspect has no increased risk;
• The Integrity aspect has no increased risk;
• The Confidentiality aspect has no increased risk;
• The Personal Data aspect does have an increased risk.

Legal basis

The subject must give unambiguous consent. He or she has signed a consent form before participating in the study. You may only process personal data if there is a lawful basis for doing so (art. 5 and 6 AVG). The AVG has the following bases: a. unambiguous consent of the data subject; b. the processing of personal data is necessary for the performance of an agreement to which the data subject is a party, or in order to take measures at the request of the data subject prior to the conclusion of an agreement; c. the processing is necessary to comply with a legal obligation incumbent on the person responsible for processing the personal data; d. the processing is necessary to protect the vital interests of the data subject or another natural person; e. the processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the person responsible for processing the personal data; f. the processing is necessary for the fulfilment of the legitimate interests of the person responsible for processing the personal data, or of a third party, except where the interests or fundamental rights and freedoms of the data subject requiring the

protection of personal data outweigh those interests, in particular where the data subject is a child.

Elaboration on impact assessments

The study was designed and launched before it was mandatory to do an impact assessment.

Impact assessment

Data Protection Impact Assessment (DPIA)

Operations

Data

Different data streams are used in the ICECREAM study. We explain them below.

The data collected with the questionnaires do not affect the information and data collected from the online behavioural intervention. HCV reinfection data and any HCV treatment data during study participation are collected through the participating centres and also do not affect the content and collected data from the online behavioural intervention or questionnaires. We seek written consent to collect this data with a consent form. In this, we also explain how the data will be requested and for what purpose. Moreover, the information we collect is only accessible to those authorised to do so and (special) personal data is pseudonymised.

In the final analyses, datasets can be linked to each other to perform analyses on.

Technical design

• Completion of questionnaires (in month 0, 6, 12, 18, 24) by participants via ICECREAM website. Participants can continue to see their answers until they close the questionnaire, then no longer.
• Participants are automatically randomised into intervention study group or combination after 6 months.
• Intervention arm 1: Participants complete modules for behavioural intervention via ICECREAM website
• Intervention arm 2: Participants receive hepatitis C home tests and receive result
• Researcher can download study data during the study for interim analyses.