Randomised controlled trial (RCT) of home HIV testing to increase HIV testing frequency

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This randomised controlled trial (RCT) aims to assess the effectiveness, acceptability and feasibility of home HIV testing among gay men in Australia. Approximately 350 high risk gay men (including 50 men who report their last HIV test was more than 24 months ago) will be recruited from clinics and community-based sites and randomised 1:1 to one of the two study arms: home HIV testing arm (intervention); or clinic HIV testing arm (control). At enrolment, all study procedures will be explained to the participants and they will be required to sign a written consent form which will cover all data collection activities of the trial. The OraQuick In-Home HIV Test will be used for home HIV testing in this study. It is a rapid self-administered over-the-counter (OTC) test which is used with an oral fluid specimen and provides a result 20 minutes after specimen collection. The test is developed by OraSure Technologies Inc., (Bethlehem, Pennsylvania, United States) and is approved for home use in the United States (US) by the Food and Drug Administration (FDA). It is not yet approved by the Therapeutic Goods Administration (TGA) of Australia, but can be imported to Australia for personal use and research purposes. This is a wait-list control RCT, with each participant followed-up for 24 months after enrolment. After initial 12 months, participants in the clinic HIV testing arm will switch to home HIV testing arm, so that all the participants will have access to home HIV testing in the last 12 months. At enrolment, men in the home testing arm will receive four OraQuick home tests with written and video instructions. Further home tests will be available on request, with a maximum of 12 kits per participant per year. Ongoing support via a 24 hour phone line will be available to men in the home HIV testing arm throughout the study. Men in both arms will have access to routine HIV testing and care at their preferred clinic. Demographic, sexual behaviour and HIV/STI testing information will be collected from participants through a self-administered questionnaire at enrolment. Every 3 months, brief information on HIV/STI tests and the results will be collected through an online self-administered questionnaire. In addition, HIV/STI test results will be collected from clinics attended by the participants during the study period. At 12 and 24 months, these questionnaires will include additional questions to collect information on acceptability of clinic and home HIV testing and confidence on the performance of home HIV test. At the end of study, selected participants will be invited to participate in in-depth interviews to obtain detailed information about their home test experience and influence on sexual behaviour.