8. 1 – 8.2 Introduction and aims

8.1 Introduction

Section 8 provides information about HIV clinical studies and research.

• It provides an introduction for people interested in HIV research.
• It includes information about how to interpret study results and on how these results are reported.

Community involvement is important.

HIV activists have always argued for active community representation and involvement at all stages of our health care, including research.

This includes being involved in which studies are needed and how they are designed.

Our involvement helps make sure:

• That the studies are run properly.
• That all participants receive at least current standard-of-care treatment.
• That enrolment runs well.
• We are included in monitoring and following early results.
• As patients and advocates we have a good idea on how latest treatment advances may affect the standard of care in the future.

Study participants need to be treated at the current best standard of care throughout the duration of the study. Community involvement can make sure that, if appropriate, the study changes to reflect any new standard of care.

Even after a study design is finalised, it often takes more than a year before the first participant is enrolled. It might then take several years for the study to fully enrol and complete.

Research therefore needs to adapt to make sure any changes in the standard of care are also included in the study.

Community advocates need training and support to be actively involved in research.

This should also be provided, as needed, by the research team who are usually are very supportive. Otherwise our involvement could just be a token to show good clinical practice, or to help get funding.

This means that as community representatives we need to learn about research.

We are also responsible for representing the broad range of people living with HIV.

8.2 Aims for this section

Section 8 covers the following issues.

• How studies are designed to produce reliable and accurate results.
• Why research is needed for us to be able to make informed choices about our treatments.
• The basic concepts used in study design.
• The main types of studies and how they produce different types of evidence.
• The advantages and disadvantages of different study designs.
• Common features of all studies, including ethics.
• Informed consent and care of participants.
• Interpreting study results.
• The different roles advocates can take.

Last updated: 1 January 2023.