What is the research study about?
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.
You have been invited to take part in the study because you have recently been diagnosed with HIV. Specifically, you are receiving this invitation because one of your service providers – with your consent – referred you to the study, and you provided your email address for this purpose.
Participation in any research study is voluntary. If you do not want to take part, you do not have to.
If you decide you want to take part in the research study, you will be asked to:
· Read the information carefully (ask questions if necessary);
· Participate in an in-depth interview with the option to participate in a follow-up interview;
· Potentially complete a 6-monthly online survey in the future.
What does participation in this research require,
and are there any risks involved?
Interviews will be confidential and no identifying details from the interview will be used in reporting the results of this study. Interviews will be conducted by a trained interviewer, recorded for accuracy, transcribed for analysis, and then de-identified. You will be asked to fill out a consent form by a member of the study team before being interviewed.
The first interview will take about 90 minutes. If you take part in an interview, you will be invited to participate in an optional follow-up interview one year later. The follow-up interview will be shorter than the first interview.
In the interviews we will ask you questions about your experience of being diagnosed with HIV, and your use of services, including peer-based HIV support. The interview will also include questions about the event that you believe led to you becoming HIV-positive.
The RISE Study also includes a survey component. You do not need to complete a survey at this time but we may ask you in the future if you would like to participate in a 6-monthly survey. Participation in the survey component of this study will be entirely voluntary. Please find more detail of the survey component of this study below.
Methodological design and implementation
Prospective cohort studies are considered the best method for determining incidence and natural history of a human condition and are especially powerful when combined with intervention research. However, they are also expensive, labor-intensive, and require significant researcher involvement.
A new research methodology, pioneered by Dr Mohamed A. Hammoud, has changed the way researchers can run cohort studies by automating enrolment, data collection and cohort maintenance; thereby reducing researcher burden, associated costs and generating new knowledge. Description of implementation and opportunities for safe data collection can be found here.
If you decide to take part in the research study, we may ask you to complete an online survey. The survey will ask you questions about: your experience of being diagnosed with HIV; relationships and sexual practices (before and after your diagnosis); your use of clinical and support services after diagnosis (and use of HIV treatments); your sense of well-being and social connectedness; and your experiences of disclosing your HIV status to others. It should take approximately 35-40 minutes to complete.
We don’t expect this survey to cause any harm or discomfort, however if you experience feelings of distress as a result of participation in this study you can let the research team know and they will provide you with assistance.
If you have been referred directly to the study from a clinic where you receive HIV care, that clinic will receive $100 after you provide your consent to participate in this research.
You will also be asked to complete a follow-up online survey every 6 months over the next 2 years (that is a total of 4 follow-up surveys). These surveys will ask you about: your current relationships and sexual practices; your use of clinical and support services; use of HIV treatments; your sense of well-being and social connectedness; and your experiences of disclosing your HIV status to others. For participants who use peer-support services of community HIV organisations, we will also ask you some evaluation questions about these services.
Consent to completing these follow-up surveys is not necessary for you to take part in the first survey.
We plan to study some other issues of relevance to people living with HIV. To look at these questions, we need your consent for the items listed below. These items do not require any extra participation on your behalf, beyond giving your consent to allow us to collect information from other sources.
If you do the survey, you will also be asked to provide consent to:
· Link your details with health and disease-related registries. Such registries include the National HIV Registry, the Australian Cancer Database, and the National Death Index. This information will allow the calculation of rates of important causes of illness and death among people living with HIV, and would be of benefit in identifying causes of these conditions.
· The research team having access to test results that have been obtained through ACCESS (The Australian Collaboration for Coordinated Enhanced Sentinel Surveillance of STIs and Blood-borne viruses). This involves the extraction of routinely collected data on clinic visits, HIV clinical markers and related tests, STI tests/results, other diagnoses, and prescribed medications.
You will not be excluded from participation if you would prefer not to participate in this part of the study. You will only be asked to consent to data linkage if you complete a survey. We will not ask you about data linkage if you participate in an interview only.
What are the possible benefits to participation?
We hope to use information we get from this research study to benefit others who are HIV positive. The results of this study will be used to inform the development of support services specifically for people who receive a new HIV diagnosis.
What will happen to information about me?
Your data will be kept for a period of 7 years after the project’s completion. We will store information about you in a non-identifiable format at UNSW Sydney. Your information will only be used for the purposes to which you consent.
Your information will be stored securely and your identity/information will only be disclosed with your permission, except in the event that it is required to be produced in response to a subpoena or warrant. If such a request is made, the researchers will be required to produce the data. You will not be identified in any publications arising from the study.
The interviews will be audio-recorded and transcribed by a professional service. All interview consent forms, contact details, audio recordings, and transcripts will be securely kept on password protected Kirby Institute servers or in a locked draw at the Kirby Institute that only the study team can access.
Submission of the online survey is an indication of your consent. By clicking the ‘I agree to participate’ button you are providing your permission for the research team to collect and use information about you for the research study.
Survey data will be collected using a secure web application for building and managing online surveys and databases. Data entered into this application runs on the UNSW’s servers, which provides increased security.
If you provide your contact details to enter the prize draw, and/or to receive the project report, your contact details will be stored separately from your survey responses. This will ensure that your responses remain confidential.
How and when will I find out what the results
of the study are?
The research team intend to publish and report the results of the research study in a variety of ways. All information published will be done in a way that will not identify you.
If you would like to receive a copy of the results you can let the research team know by emailing the RISE Study at [email protected].
What if I want to withdraw from the research study?
Your decision not to participate or to withdraw from the study will not affect your relationship with UNSW Sydney, or any state/territory health department, or clinical or community service.
The information you provide is personal information for the purposes of the Privacy and Personal Information Protection Act 1998 (NSW). You have the right of access to personal information held about you by the University, the right to request correction and amendment of it, and the right to make a compliant about a breach of the Information Protection Principles as contained in the PPIP Act. Further information on how the University protects personal information is available in the UNSW Privacy Management Plan.
You can withdraw from participating in an interview at any time during the interview process. If you want to withdraw before, during, or after being interviewed all you need to do is tell the member of the study team in contact with you. If you have already participated in an interview you will be asked to complete a withdrawal of participation form. This form will be securely stored on the password-protected Kirby Institute servers or in a locked draw that only members of the study team have access to. After withdrawal, you will not be contacted again.
If you do consent to participate in the online survey, you may withdraw at any time. You can do this by closing the survey. If you withdraw from the research we will destroy any information that has already been collected. Once you have submitted the survey however, we will not be able to withdraw your responses as the survey is anonymous.
Follow-up surveys and data linkage
If you do consent to participate in the follow-up surveys, you may still withdraw at any time. You can do so by completing the ‘Withdrawal of Consent Form’ which is provided at the end of this document. Alternatively you can phone the research team and tell them you no longer want to participate. If you decide to leave the research study, the researchers will destroy any information that has already been collected and no additional information will be collected from you.
What should I do if I have further questions about my involvement in the research study?
The person you may need to contact will depend on the nature of your query. If you require further information regarding this study or if you have any problems which may be related to your involvement in the study, you can contact the following member/s of the research team:
Research Team Contact
Associate Professor Garrett Prestage
(02) 9385 0959
If at any stage during the study you become distressed or require additional support from someone not involved in the research please call:
(Free national telephone support 24 hours/7 days a week)
1300 224 636
(Free national telephone crisis support 24 hours/7 days a week)
13 11 14
(Free national telephone and web counselling for LGBTI people 3pm-12am daily)
1800 184 527
What if I have a complaint or any concerns about the research study?
If you have a complaint regarding any aspect of the study or the way it is being conducted, please contact the UNSW Human Ethics Coordinator:
Complaints Contact - Human Research Ethics Coordinator + 61 2 9385 6222
HC Reference Number