PARTICIPANT INFORMATION

1. What is the research study about?
The research study aims to investigate the experiences of the coronavirus (COVID-19) and its impact on trends in HIV and other sexually transmissible infections among gay and bisexual men.
The project will also explore lived experiences of COVID-19 among gay and bisexual men including isolation, support, mental health and resilience, income loss, and access to health services. We will address how gay and bisexual men experience, engage with, and emerge from, COVID-19-induced social, economic and behavioural change. 
This project will:
  • Measure the extent of and identify factors for the impact of COVID-19 on sexual, drug using, and health-seeking behaviours and social connectedness among gay and bisexual men.
  • Measure the impact of COVID-19 on pre-existing epidemics among gay and bisexual men.
2. Who is conducting this research?
The study is being conducted by The Kirby Institute for infection and immunity in society. The study has been designed with the active participation of gay community and HIV organisations. The study is being carried out by the following researchers:
Lead Investigator: 
  • Associate Professor Garrett Prestage, Kirby Institute, UNSW Sydney.
Coordinating Chief Investigator: 
  • Dr Mohamed A. Hammoud, Kirby Institute, UNSW Sydney.
Co-chief Investigators
  • Professor Lisa Maher, Kirby Institute, UNSW Sydney.
  • Dr Bridget Haire, Kirby Institute, UNSW Sydney.
  • Associate Professor Adam Bourne, Australian Research Centre in Sex, Health and Society, La Trobe University.
  • Professor Louisa Degenhardt, National Drug and Alcohol Research Centre (NDARC), UNSW Sydney.
  • Dr Toby Lea, Centre for Social Research in Health, UNSW Sydney.
  • Dr Jeff Jin, Kirby Institute, UNSW Sydney.
  • Dr Peter Saxton, Department of Social and Community Health, School of Population Health, University of Auckland.
  • Professor Martin Holt, Centre for Social Research in Health, UNSW Sydney.
  • Professor Andrew Grulich, Kirby Institute, UNSW Sydney.
  • Dr Benjamin Bavinton, Kirby Institute, UNSW Sydney.
  • Dr Dean Murphy, Kirby Institute, UNSW Sydney.
Associate Investigators:
  • Dr Jeanne Ellard, AFAO.
  • Nicky Bath, National LGBTI Health Alliance.
  • Brent Mackie, ACON.
  • Colin Batrouney, Thorne Harbour Health.
Study Team: 
  • Daniel Storer, Kirby Institute, UNSW Sydney.
This research is being funded by the Kirby Institute, UNSW Sydney.
3. What are the inclusion and exclusion criteria? 
Before you decide to participate in this research project, we need to ensure that it is ok for you to take part. The research study is looking to recruit people who meet the following criteria:
  • Age 16 years or older.
  • Cisgender male, transman, intersex male.
  • Self-identify as gay or bisexual or otherwise same-sex attracted or had sex with another man in the preceding 12 months.
  • Currently living in Australia.
  • Ability to provide consent to participate in the study.
 
Exclusion criteria for those who are not eligible to participate in the study includes:
  • Under 16 years of age.
  • Not living in Australia.
We are interested in enrolling a broad cross section of men who have sex with men, and all men who meet the criteria above are welcome to participate in the study.
4. Do I have to take part in this research study?
Participation in any research project is voluntary. If you do not want to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
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);
  • If you would like to participate, sign the consent form and;
  • Save a copy of the consent form. 
 
5. What does participation in this research require, and are there any risks involved?
If you decide to take part in the research study, we will ask you to complete the following tasks:
Completion of an Online Questionnaire
The research team will ask you to complete an online baseline questionnaire, which will take up to 30 minutes to complete and will collect: demographic characteristics, HIV and STI testing, drug use, mental health, sexual behaviour, and social connectedness.. COVID-19 specific items will include: SARS-Cov2 testing, social distancing practices, COVID-19 knowledge and beliefs, and changes in circumstances and behaviour due to COVID-19.
 
Biannual questionnaires: Every 6 months, you will be asked to complete a follow-up online questionnaire, which will take up to 20 minutes to complete.
Weekly diary: Participants who consent to participation in the weekly diary will each week receive an invitation to complete a brief questionnaire measuring HIV sexual risk behaviour, HIV treatment and prevention, illicit drug use, social connectedness, and mental health. This weekly questionnaire will take about 5 minutes to complete, but is not a requirement for participation in the study and run for 6-months. At the conclusion of each 6-monthly follow-up period, we will reassess whether there remains a need for the weekly diary, and if it is decided to continue this component of the study, participants will be again asked for their consent at that time. This brief survey will enable us to measure changes in behaviours against the rapid changes in social distancing regulations as they are enforced, or relaxed.
 
You are free to withdraw from the research at any time. If you withdraw from the research we will not collect additional information from you and we will destroy any identifying information that has already been collected.
 
Optional Participant for an In-Depth Interview
Consenting participants will be invited to be interviewed in depth. This interview will be conducted confidentially, by phone or online. This interview will be conducted by a trained interviewer, recorded for accuracy, and then transcribed for analysis. All recordings will be destroyed upon transcription. This interview should take 90 minutes on average, and will NOT be required for participation in the online cohort. No identifying details from the interview will be used in results or reporting of this study.
 
You are free to stop the interview at any time. If you withdraw from the research we will destroy any information that has already been collected.
 
We do not expect completion of the online questionnaires or the questions asked during the in-depth interview 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. Alternatively, lists of services are provided in the contact details below to assist you if necessary.
 
6. What are the possible benefits to participation?
Information from this research study will enable us to monitor changes in relevant behaviours and circumstances before, during, and after the initial impact of the COVID-19 pandemic, and their potential impact on HIV and STI epidemiological trends, among gay and bisexual men. Data collected by this project will position Australia to rapidly respond to community needs and potential changes in the epidemiology of HIV and other STIs and will inform efforts by government, community and clinical partners to respond to COVID-19 impacts in Australia.
 
Data collected will assist in addressing and understanding a pivotal aspect of the pandemic: how social distancing requirements due to COVID-19 will impact sexual and other relevant behaviours and social connectedness among gay and bisexual men to inform a better understanding of HIV and other STI epidemiological trends during and following the pandemic.
 
Outcomes include social, economic and behavioural data on the impacts of COVID-19 on gay and bisexual men, important lessons about how policy responses may affect behaviours that may underlie observed increases or decreases in HIV and STI trends, and evidence to inform the development of strategies for future pandemic prevention and management.
 
This project will produce vital social, economic and behavioural data on the impacts of COVID-19 on gay and bisexual men nationwide. Understanding the impacts on, and the needs and experiences of, gay and bisexual men over the coming 12 months will be vital to the post-pandemic transition and understanding ongoing epidemiological trends in HIV and other STIs.
7. What will happen to information about me?
Your confidentiality will be maintained at all times and no identifying details will be linked to your responses. At consent, you will be provided with a study identification number that will be used in place of your identifying information. By signing the consent form you consent to the research team collecting and using information about you for the research study. We will keep your data for 7 years.
 
All data will be securely saved and is compliant and certified under both the EU-U.S. Privacy Shield and Swiss-US Privacy Shield. All electronic databases will be protected by password and UNSW Sydney firewalls.
Your information will only be used to contact you to complete a questionnaire and is sent from an external database, separate to your responses.
8. How and when will I find out what the results of the research 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.
 
Results are disseminated through published reports, journal articles, conference presentations, local workshops, community newspaper / magazine articles, and consultations to professional organisations. The data will also be presented in other media formats if these become available. In whatever format these data are presented, confidentiality will always be protected as outlined.
Findings will be made available to participants in the same manner as outlined above. Participants are provided this information and how they can access reports of findings on the information sheet. Also reports of findings will be publicised on the Kirby Institute website.
  • Participants can choose to like the study page. (participants hidden from each other)
  • Updates on latest publications
  • Opt in for half-yearly newsletters
  • Study website detailing all peer-reviewed publications, conference, and community presentations
 
9. What if I want to withdraw from the research study?
If you do consent to participate, you may 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 ring the research team and tell them you no longer want to participate.  If you decide to leave the research study, the researchers will not collect additional information from you.  Your decision not to participate will not affect your relationship with UNSW Australia.
10. 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 want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the following member/s of the research team:
11. Support Services Contact Details
The researchers anticipate no discomforts/harms to our participants. In the unlikely event that completing this survey should suffer any distress, there will be a page on the study website and within the online survey or diary entry which will offer you contact details for appropriate organisations offering free counselling, information and advice on all topics covered by this survey, should you wish to speak with someone about the feelings or thoughts they may be having or related to any adverse responses they are experiencing. The study team consists of experienced research staff familiar with the study population who are well-placed to assist participants who may be undergoing psychological stress and who utilise our established network of formal referral mechanisms.
 
If at any stage during the project you become distressed or require additional support from someone not involved in the research, please call:
Name: Associate Professor Garrett Prestage
Position: Kirby Institute, UNSW Sydney
Telephone: (02) 9385 0939
What if I have a complaint or any concerns about the research study?
If you have any complaints about any aspect of the project, the way it is being conducted, then you may contact:
Position: Human Research Ethics Coordinator
Telephone: (02) 9385 6222
Email: humanethics@unsw.edu.au 
HC Reference Number: HC200286
Looking for more information? 
If you'd like more information, send an email to flux@kirby.unsw.edu.au 

© 2020 The Flux Study