Clinical Research

Clinical research studies or trials help answer questions about people’s health and new ways to treat, diagnose, or prevent diseases. There are many different types of clinical research, but at PHNTX, we mostly conduct clinical trials that study the effects of an intervention or treatment on people’s health. Researchers want to learn if new medications or tests are effective, what kind of side effects they cause, and which people may benefit most from a new treatment. In order to learn the answers to these questions, researchers need people to volunteer for clinical trials to test the new intervention or treatment. Participation in a clinical trial is always voluntary, and you will be fully informed about the study before you make a final decision about participation.

IRB stands for Institutional Review Board. The IRB is a committee of people who do not work for the research site that reviews research study protocols and proposals and ensures that studies are ethical. IRBs are in place to protect the rights and welfare of research study participants. All studies must be approved by an IRB before sites can begin enrolling participants in the study.

Clinicaltrials.gov is a website run by the National Institutes of Health. The Food and Drug Administration requires that all clinical trials be registered on the website. You can find information about trials that are currently seeking participants in your area and more information about studies you may be interested in. Anyone can access clinicaltrials.gov without a login.

Informed consent is a process where people who want to participate in a research trial learn about the study including:

• the purpose or objectives of the trial
• what is required of them as a participant
• what kind of procedures are involved
• how long the study will last
• known risks and benefits of participating in the trial
• alternatives to participating in the trial
• confidentiality
• and cost and compensation information

All of this information and more is included in a document called an Informed Consent Form or ICF. At the screening visit, you will be given a copy of the ICF to read and review, and you will go over it with the study team in detail. You should only sign the ICF after you fully understand all of the information, all of your questions have been answered, and you have voluntarily decided to participate in the trial. During the course of the study, there may be updates to informed consent when new information becomes available. If there are updates, the study team will go over the updates with you, and you can decide if you want to continue participating in the trial at that time.

In a Phase 1 study, scientists and doctors want to see if a new medicine or treatment is safe for people. They give it to a small group of volunteers (usually healthy ones) to see how their bodies react. The scientists check to make sure the new treatment doesn’t cause any big problems and that it doesn’t have harmful side effects. If everything goes well in Phase 1, then they can think about moving on to bigger studies to see if the treatment actually works for people who need it.

In a Phase 2 study, scientists and doctors take the new treatment that showed promise in Phase 1 and give it to a bigger group of people who actually have the condition it’s meant to help. They want to see if it works well for them and if it’s still safe. During Phase 2, researchers are paying attention to whether the treatment is effective in treating the health issue and if it causes any side effects. If everything continues to look good, then they might move on to the next step, which is a Phase 3 study.

In a Phase 3 study, scientists and doctors take the treatment that seemed effective and safe in Phase 2 and give it to a much larger group of people, sometimes even thousands. These people have the same health condition that the treatment is supposed to help. The researchers want to gather a lot of information to make sure the treatment works well for most people and that any possible side effects are well understood.

A Phase 4 study is like checking up on a medicine or treatment after it’s already been approved and used by lots of people. In Phase 4, researchers look at how the medicine or treatment is doing in the real world with many different people using it. They want to know if any new side effects show up, if it’s still helping people, and if there are any long‐term effects.

It depends. Some studies may be only a single visit, some may last a few weeks, and others can go on for several years. Sometimes studies are extended, and sometimes they end earlier than planned. Your study coordinator will explain how long the study is anticipated to last during the informed consent process and will keep you updated on any changes during the course of the study.

Yes, research studies at Prism Health North Texas do pay a stipend for each completed visit. The amount depends on the study you are participating in, and your study coordinator will tell you how much the stipends are during the informed consent process. Stipends will be paid using a reloadable MasterCard gift card given to you at your first study visit.

It depends. Some studies will allow participants to join another study, especially if one or more does not involve taking a new medication. However, it is very important to discuss this with your study coordinator before joining multiple studies to make sure that it is allowed and that you will not have health issues that may arise by participating in multiple studies.

No, you will continue to have routine follow-up visits with your doctor or other medical provider and will continue to have routine labs drawn outside of the study. It is important to continue to go to your appointments as they will cover your healthcare needs that are unrelated to the study. These visit costs will not be covered by research.

Study participation is always completely voluntary. You can change your mind for any reason at any time and leave the study without penalty. The study team does ask that you reach out to your study coordinator and principal investigator to discuss the next steps if you decide you no longer want to participate or no longer have time to participate or to see if there is a way the study can accommodate a change in your schedule.

Please contact your study coordinator as soon as you know you will not be able to make it to your appointment or if you need to be out of town during your scheduled appointment. Your coordinator can help reschedule your appointment and make arrangements to make sure you do not run out of your study medications.

Most research studies are conducted at sites around the United States and the world. If you are moving out of the area and wish to continue participating in the study, your study coordinator can find out if there is a research site in the area you are moving to. If you no longer wish to participate, that is okay too ‐ study participation is always voluntary. Talk to your study coordinator about any concerns you have regarding moving out of the area while participating in a study.

Research studies follow a schedule of visits on certain days, which will be explained to you during the informed consent process. Sometimes, participants need to come in outside of the regularly scheduled visits. The research staff may need you to come back for additional labs or for a medical provider to see you, or you may need to call and schedule a visit to be seen if you are experiencing something new. These are called unscheduled visits. Your study coordinator will help schedule these appointments with you when necessary.

It depends. Most studies do pay stipends for a set number of unscheduled visits if those visits are required by the study or PI. Your study coordinator will be able to tell you about your specific study.

It depends. Each study has different medications that you may not be able to take at the same time as the study drug. It is very important that you tell your study coordinator and the principal investigator about any new medications you are taking or have been prescribed to make sure that it is safe to take with the study medication.

It depends. For some studies, you will continue to take the medication you currently take. For other studies, you will be taking a new medication as part of the study and will stop taking your current medications. The principal investigator and study coordinator will explain all of the details about your study during the informed consent process and will be very clear about if or when to change medications. It is very important to follow the instructions of the research staff about which HIV medications to take during the study.

It depends. Studies generally cover the cost of the study drug and may cover the cost of all HIV medications during the study. However, in unblinded studies, the sponsor may require that participants continue to pay for their own medication (through insurance, ADAP, or the payment program participants are currently using) if they are randomized to stay on their current treatment. The details of your particular study will be explained during the informed consent process. If you have any questions or concerns, you can ask your study coordinator or principal investigator.

If you miss a dose or multiple doses of your study medication and you aren’t sure what to do, call your study coordinator. They can explain when you should take your next dose and if you might need to be seen in the clinic.

Most studies require that participants bring back their remaining study medications and empty bottles to their next research appointment. If you forget, it’s okay. Your study coordinator will explain what to do, and you can usually bring your bottles to your next appointment.

If you lose your study medication, contact your study coordinator right away. They will be able to help you get new medications quickly. Do not start taking your previous regimen (non‐study medication) without talking to your study coordinator.

You should be given enough medication to make it to your next study visit without running out. However, if you notice that you will run out before your next scheduled appointment, please call your coordinator right away. They will let you know if your appointment needs to be earlier or if you need to come in for an unscheduled visit.

One of the things that research studies are trying to find out is what kind of side effects people have when taking the study medication. It is important to tell the research team about any new symptoms you experience once you start taking study treatment so the symptoms can be assessed by the study doctor. Then, the study doctor can help determine if it is safe for you to continue taking the study medication. Remember, study participation is always voluntary.

Your health and lab work will be closely monitored during the course of the study. If the study doctor or sponsor determines that the medication is not working for you, they will work with you on a plan for what to do next, and you will be kept informed and help make decisions for yourself every step of the way.

No, in HIV treatment studies you will be given an active medication unless clearly explained by the study staff during the informed consent process. The study staff will also explain to you when a placebo may be used along with an active medication, such as in a double-blind trial. During the informed consent process, your study coordinator will explain all possible treatment groups for the study. You will not be given any other treatment option that is not clearly explained as a possibility in the informed consent process.

It depends. Many studies require that participants assigned female at birth who have sex with partners assigned male at birth use a highly effective form of birth control or contraception during the study. Some studies require that participants assigned male at birth use condoms or another form of contraception when having sex with partners assigned female at birth. Your study coordinator will tell you if birth control is required and what kind of birth control could be used for the study you are interested in.

Yes, lab results made available to the research team can be shared with participants. If there are any changes to your labs that are concerning to the principal investigator, your results will be explained to you and you will be asked to return to the research site for additional labs and further evaluation. Sometimes, there may be certain results that are not made available to the principal investigator by the study sponsor, but this will be explained to you during the informed consent process if it applies to your study.

It depends. Finding out what medication you are or were taking is called unblinding. Some double-blind studies don’t unblind participants and research staff until the end of the study or even after the study is over. Other studies unblind participants and research staff partway through a study and then have study participants switch to the study drug if they were on their initial treatment. The principal investigator and study coordinator will keep you informed about unblinding during your study.

It is very important that you tell your study coordinator and the principal investigator about any new diagnosis you receive or new symptoms you experience while participating in a research study. Often nothing will change about your participation, but it is important that the principal investigator is aware of any new health concerns you may have during the study so they can help determine if it is safe for you to continue to take the study drug.

It depends. Each study has different guidelines for what will happen if you become pregnant while participating in a research study. It is very important that you call your study coordinator immediately if you learn you are pregnant or think you might be pregnant while participating in a research study. Your study coordinator will provide you with more information.

It depends. Your study coordinator can tell you more about the rules regarding sperm donation while participating in your particular study.