FAQs about Participating in a Trial
1. What is
involved in participating in an
biomedical HIV prevention clinical
trial?
Joining an biomedical HIV prevention clinical trial is a serious investment of time and energy. Participation often lasts at least a year if not a few years, and it requires consistent communication with the trial researchers and nurses. Clinical trial participation can be broken down into 6 stages:
First Contact
This stage refers to the first time a potential clinical trial volunteer hears about a biomedical HIV prevention research strategy. This might happen in a few different ways, you may read a poster or flier, you may be approached by an outreach worker or you may hear an ad on the radio or on television. Whatever the means, you should be provided some basic information about the trial - the purpose of the trial, who they are looking to get as volunteers, how long the trial will last, and a contact for further information.
The next two stages may happen at the same time or in reverse order, it depends on the trial and trial site.
Informed consent
This is when potential trial volunteers are provided information about all that is involved in participating in research. You should receive information explaining the rationale for the study, the nature of the experimental intervention, any possible known side effects of the strategy, the study design, all procedures that will occur during the trial, any potential risks and/or benefits of participation, the personal implications of participation, mechanisms for maintaining confidentiality, and your right to withdraw from the trial at any time. Only after considering all of these things are people asked to participate in the trial. Often participants are asked to sign a document to state they have received and understood the information provided.
Screening
This stage also happens before a potential volunteer is enrolled in a trial. A series of tests are conducted to ensure the potential volunteer meets the inclusion criteria, or has the required characteristics needed to be in the trial. There are also exclusion criteria, or characteristics that would exclude a person from being in a clinical trial. Inclusion and exclusion criteria are different for each trial.
Enrollment and the trial
After going through the informed consent and screening processes, the individual is enrolled into the trial and the trial procedures begin.
Trial end and results
After you've completed your final visit and taken your last set of medical tests, your participation in the trial comes to an end. All trial participants should be informed of the results of the trial, as well as whether you received the vaccine or placebo.
After efficacy
This is what we are hoping to accomplish, find biomedical HIV prevention strategies that are proven safe and effective in large scale clinical trials. But even after an intervention method is proven effective, there is still much to do. Issues related to product licensure, manufacturing, purchasing and distribution/access must still be worked out to make sure the people who need the product the most are able to get it.
For more details see Finding Your Way (PDF).
2. Is participating in an biomedical HIV prevention clinical trial safe?
To date, there have been no deaths or serious injuries caused by an experimental biomedical HIV prevention strategy. However, with any clinical trial of an experimental product, there are potential risks. You should be sure to learn as much as you can through the informed consent process in order to make your own decisions about whether participating in a vaccine clinical trial is right for you.
3. Is there an biomedical HIV prevention clinical trial in my community?
There are biomedical HIV prevention clinical trials happening all over the world. See our global map of clinical trial sites to find out if there is one near you.
4. What happens if I am injured as a result of participating in a biomedical HIV prevention clinical trial?
Ethical guidelines for research involving human subjects require that individuals are compensated for any injury that is a result of participating in a clinical trial. How that happens depends on the trial sponsor, the research institution and the community in which the research is taking place. You should be sure to find out the specific details of this issue through the informed consent process or by asking your local research site.
5. Will I get paid for participating in a biomedical HIV prevention clinical trial?
Generally clinical trial volunteers are not paid to participate in HIV prevention trials - though many research sites will provide some compensation for travel and time but it depends on the research site. For the most part, paying trial participants is not common because it could potentially coerce people who would not normally join a clinical trial to volunteer - especially if they are part of a vulnerable population.
Joining an biomedical HIV prevention clinical trial is a serious investment of time and energy. Participation often lasts at least a year if not a few years, and it requires consistent communication with the trial researchers and nurses. Clinical trial participation can be broken down into 6 stages:
First Contact
This stage refers to the first time a potential clinical trial volunteer hears about a biomedical HIV prevention research strategy. This might happen in a few different ways, you may read a poster or flier, you may be approached by an outreach worker or you may hear an ad on the radio or on television. Whatever the means, you should be provided some basic information about the trial - the purpose of the trial, who they are looking to get as volunteers, how long the trial will last, and a contact for further information.
The next two stages may happen at the same time or in reverse order, it depends on the trial and trial site.
Informed consent
This is when potential trial volunteers are provided information about all that is involved in participating in research. You should receive information explaining the rationale for the study, the nature of the experimental intervention, any possible known side effects of the strategy, the study design, all procedures that will occur during the trial, any potential risks and/or benefits of participation, the personal implications of participation, mechanisms for maintaining confidentiality, and your right to withdraw from the trial at any time. Only after considering all of these things are people asked to participate in the trial. Often participants are asked to sign a document to state they have received and understood the information provided.
Screening
This stage also happens before a potential volunteer is enrolled in a trial. A series of tests are conducted to ensure the potential volunteer meets the inclusion criteria, or has the required characteristics needed to be in the trial. There are also exclusion criteria, or characteristics that would exclude a person from being in a clinical trial. Inclusion and exclusion criteria are different for each trial.
Enrollment and the trial
After going through the informed consent and screening processes, the individual is enrolled into the trial and the trial procedures begin.
Trial end and results
After you've completed your final visit and taken your last set of medical tests, your participation in the trial comes to an end. All trial participants should be informed of the results of the trial, as well as whether you received the vaccine or placebo.
After efficacy
This is what we are hoping to accomplish, find biomedical HIV prevention strategies that are proven safe and effective in large scale clinical trials. But even after an intervention method is proven effective, there is still much to do. Issues related to product licensure, manufacturing, purchasing and distribution/access must still be worked out to make sure the people who need the product the most are able to get it.
For more details see Finding Your Way (PDF).
2. Is participating in an biomedical HIV prevention clinical trial safe?
To date, there have been no deaths or serious injuries caused by an experimental biomedical HIV prevention strategy. However, with any clinical trial of an experimental product, there are potential risks. You should be sure to learn as much as you can through the informed consent process in order to make your own decisions about whether participating in a vaccine clinical trial is right for you.
3. Is there an biomedical HIV prevention clinical trial in my community?
There are biomedical HIV prevention clinical trials happening all over the world. See our global map of clinical trial sites to find out if there is one near you.
4. What happens if I am injured as a result of participating in a biomedical HIV prevention clinical trial?
Ethical guidelines for research involving human subjects require that individuals are compensated for any injury that is a result of participating in a clinical trial. How that happens depends on the trial sponsor, the research institution and the community in which the research is taking place. You should be sure to find out the specific details of this issue through the informed consent process or by asking your local research site.
5. Will I get paid for participating in a biomedical HIV prevention clinical trial?
Generally clinical trial volunteers are not paid to participate in HIV prevention trials - though many research sites will provide some compensation for travel and time but it depends on the research site. For the most part, paying trial participants is not common because it could potentially coerce people who would not normally join a clinical trial to volunteer - especially if they are part of a vulnerable population.