Participating in Trials
Participating in clinical trials is one of the most important decisions you may make about your current and future health, so it is useful to discuss your interests to participate in a trial with a broad range of people, including your peers, your doctor and the trial researchers.
Trial researchers are ethically obliged to provide you consent information about the trial you are anticipating to enter, including the perceived benefits of participating as well as the possible risks.
You do not have to make a decision whether to enter a trial in any immediate sense, in fact it is best advised to take the information you are given and think about it fully.
Trials usually have a recruitment time period for you to take your time to consider whether you will participate. However, some trials fill up quickly or they have limited places available for the study.
Also be aware that some trials – both clinical and social researcher trials – have inclusion and exclusion criteria which you are required to meet before you can participate in the trial. A simple example might be your current age, for a trial that is only seeking to study participants of a certain age range, or above or below a certain age – if you don’t fit the age requirement you cannot enter the trial.
Clinical trials (which involved medical treatments or interventions) can tend to have complex inclusion criteria, such as the level of your CD4 and other clinical markers – but again trial researchers will explain these things to you.
Your decision to participate in trials becomes especially important when it is a clinical trial (often involving a new experimental treatment or drug, as the intervention/drug has not been proven to be either effective or efficacious yet – as that is the reason for the trial). However such clinical trials, when conducted in humans, are required to have met stringent pre-trials about the safety of the treatment or intervention being proposed. Human trials are usually stage 2, or more often stage 3 trials, and have previously been assessed for safety in stage 1 and stage 2 trials.
Social research studies tend to comprise a lower risk for participating, as these studies tend to seek your narrative story and comments about your experiences with the topic being investigated under the study (for example, experiences of stigma, or experiences of being newly diagnosed with HIV).
These studies are not without risks though and your consent to participate is also sought from the researchers, who are also ethically required to advise you about the intent of the research as well as the benefits and risks of participating.
Very often these are self-evident however, say such as completing a short online survey. The difference in terms as to what comprises a small survey versus a research study versus a major trial with comparison groups, exist within a continuum of the range and types of research that is carried out.
Once you enter a study you also have the right to withdraw consent from your participating in the study – entering a study does not oblige you to complete the study.
Generally the benefit of research is that it assists the majority of people and helps to discover new science and evidence for health and treatment for the benefit of the entire population.
You may or may not get individual benefits from participating in any given trial. These considerations are up to you to weigh up your self-interests in participating, alongside benefits to your peers from participating. The decision to be in a trial is your own.
Want more information on trials being conducted in Australia? Visit the following websites for more information:
If you have any questions about HIV treatment, please call QPP toll free from a land-line on 1800 636 241, use the contact form provided or call (07) 3013 5555 (nationally).
There have been exciting opportunities for PLHIV to participate in research that aimed to better understand people’s experiences of living with HIV, ageing and social isolation in diverse communities in regional, rural and outer urban Queensland.
Researchers from the University of Queensland and University of New South Wales, in partnership with Queensland Positive People, Positive Directions, Queensland Association for Healthy Communities and Queensland Health undertook an exciting Queensland specific qualitative longitudinal research project. This focused on better understanding people’s experiences of living with HIV, aging and social isolation in diverse communities in Regional and Rural Queensland.
If you are interested in the study, or have some questions, please contact:
Dr Lisa Fitzgerald – School of Population Health – The University of Queensland
P 07 3365 5541/07 3346 5244 E firstname.lastname@example.org P 288 Herston Rd Herston 4006
2. Opposites Attract Study?
Opposites Attract is a globally unique study exploring a range of important issues relating to HIV transmission and viral load in gay male serodiscordant (pos/neg) relationships.
Previous research in heterosexual couples has shown that when the HIV-positive partner is on anti-HIV treatments and has undetectable viral load, the risk of transmitting HIV to their HIV-negative partner is reduced by 96%.
But now the next question is to what extent this important finding applies to gay men.
The study conducted by The Kirby Institute, has shown that HIV positive men who are on treatment and have an undetectable viral load (UVL) do not transmit HIV to their partners. For more information, visit www.oppositesattract.net.au
3. Experiences of HIV – The Seroconversion Study
The Seroconversion Study was a study of people in Australia recently diagnosed with HIV. This research ran between 2007-2015, and continues to make a real difference to the lives of people affected by HIV.
The ways HIV can affect our lives has changed over time, and it is crucial to gather current, relevant information about those experiences.
For more information, visit https://siren.org.au/wp-content/uploads/2016/08/Key-findings-HIV-seroconversion-study-Jul2016.pdf
The information collected in this survey plays a major role in health promotion for those affected by HIV, assists in prevention efforts by local communities, and aids in addressing the needs of those dealing with a recent HIV diagnosis.
For more information: Email email@example.com or Phone 02 9385 9954
4. RISE – Recently Diagnosed and the Impact of Support of the Experience of HIV
This research study aims to explore experiences of being diagnosed with HIV, as well as to investigate the impact of accessing HIV support services on people’s overall well-being, their access to HIV clinical care, and their uptake of HIV treatments. In addition, the study aims to identify contemporary factors associated with HIV infection.
The study consists of an initial online survey, which should take about 35–45 minutes. After this, the researcher team will then send you a shorter follow-up survey every 6 months.
As well as the online survey, the research team will provide you with the opportunity to take part in an optional in-depth interview. The interview will provide an opportunity for you to talk about your experience of HIV in more detail.
To be eligible to participate in RISE, you must be:
- Aged 16 years or above.
- Currently living in Australia.
- Diagnosed with HIV since 2016
If you would like more information on RISE, please follow the link to the RISE website.