This trial is fully enrolled. This means that all of the available places on the trial have been filled. You cannot enrol in this trial.
About this trial
This trial is looking at whether providing HIV negative MSM with rapid HIV tests increases how often they test. MSM who presented for HIV testing at Melbourne Sexual Health Centre were randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant to either receive rapid testing - an immunochromatographic test using a fingerprick blood sample and providing a result in 20 minutes - or traditional testing requiring a follow-up appointment in one week's time.
The trial is fully enrolledThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. with follow-ups expected to continue until Sept 2012.
At present, about 50% of homosexual men have HIV tests at least once per year. Increasing this proportion is predicted to reduce the rate of HIV transmission in the population, due to changes in sexual behaviour brought about by diagnosis. Rapid HIV tests are not currently approved or available for general use in Australia, but these may prove more accepatable because patients do not need to return for a second consultation for their result and a less invasive sample is required. This study is a randomised trialA clinical trial in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. of the effect of making rapid HIV tests available to men having sex with men (MSM) on the frequency with which they have HIV tests.
Consenting HIV-negative MSM requesting an HIV test at Melbourne Sexual Health Centre (MSHC) will be randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant in equal proportion to either onging access to a rapid test for 18 months or to standard laboratory-based serology (which requires them to return for their result in a week).
This is not blindedA randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked.; both groups are sent three-monthly reminders by e-mail and SMS, reminding them of their study allocation, and asking them to complete six-monthly questionnaires on sexual behaviour and whether they have had HIV tests elsewhere.
|Official title:||Do homosexual men test more frequently for human immunodeficiency virus (HIV) with rapid tests? A randomised controlled trial. |
|What is this trial studying?||Other|
|How many participants will this trial enrol?||400 |
The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.
|How long is this trial planned to go for?||Participants in this trial will be asked to follow the trial protocol for 18 months.|
|Links to further information:|
Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- This trial is for men only
- Men with male sexual partner within past year
Requesting HIV test on day of enrolment
HIV test within past two years
HIV negative at last test
You will not
be eligible to participate in this trial if you meet any of the following criteria:
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.