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HIV Clinical Trials:
The Plain-Language Guide

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Health information — Educational information, not medical advice. Talk with your healthcare provider about your care and treatment decisions.

ClinicalTrials.gov lists thousands of HIV studies. Most people with HIV have no idea how to find them, read them, or know if they qualify. This guide changes that — no medical degree required.

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HIV treatments become available through clinical research and the volunteers who make it possible. A trial may offer access to an investigational treatment and study-related monitoring, but personal benefit is uncertain. Payment, reimbursement, and costs differ by study; review them in the consent form before enrolling.

But ClinicalTrials.gov — the federal database where all trials are registered — was designed by scientists for scientists. The language is dense, the search tools are clunky, and most people who land on it leave more confused than when they arrived. This guide is the decoder ring.

What to expect: HIV studies range from a single visit to years of follow-up. Some keep your current treatment unchanged; others test a switch or a carefully monitored treatment interruption. Ask about the specific risks, visits, costs, and payment schedule. Participation is voluntary, and you can ask questions or leave the study.

What a clinical trial actually is

A clinical trial is a research study in which people volunteer to help answer a specific medical question. Not all clinical trials test new drugs. HIV trials in 2026 include studies of new treatment regimens, cure strategies, prevention approaches, wellness interventions, behavioral support, and care delivery models. Some require nothing more than answering questions. Others involve new medications, procedures, or lab work.

Clinical trials follow a protocol describing the research question, procedures, eligibility, and monitoring. U.S. research subject to FDA or HHS human-subject protections requires appropriate ethics review. IRB approval helps protect participants but does not establish that an experimental intervention is safe or effective. ClinicalTrials.gov registration is required for certain trials by law or policy, not every study worldwide; a listing is not government endorsement.[2][1]

Participation is always voluntary. You can ask questions before deciding. You can change your mind after enrolling. You cannot be penalized for withdrawing. These are not suggestions — they are federal requirements.[3]

The jargon, decoded

Clinical trial documents are full of terms that sound intimidating but aren't. Here are the ones you'll encounter most often:

Protocol
The study's rulebook. It describes exactly what will happen — what visits you'll have, what tests will be done, what you'll receive, and when. Ask the research team to explain the protocol and provide the participant information and signed consent materials.
Informed Consent
A document — and a process — that explains the study in plain language, including reasonably foreseeable risks, potential benefits, and uncertainty. Consent is generally documented before participation, with legally permitted exceptions in some research. Signing is not a contract you can't break; it's acknowledgment that you understand what you're agreeing to.
IRB
Institutional Review Board. An ethics committee that reviews research covered by applicable human-subject protections. Their job is to protect participants, not advance the research.
Eligibility Criteria
The specific requirements to participate — including "inclusion criteria" (what you need to have) and "exclusion criteria" (what rules you out). Not meeting criteria doesn't mean you did anything wrong — it means the study needs a specific population.
Randomization
Random assignment to a treatment group — like flipping a coin. This helps reduce selection bias. Neither you nor your doctor chooses which arm you're in.
Placebo
An inactive treatment (like a sugar pill) given to one group in a trial so researchers can compare it to the real treatment. In HIV treatment trials, you will not be given a placebo instead of your standard HIV meds — that would be unethical. Placebos appear in add-on treatment studies where both groups continue their standard ART.
Blinded / Double-Blind
A "blinded" study means participants don't know which arm they're in. "Double-blind" means neither participants nor researchers know until the study ends. This reduces bias in reporting outcomes.
Arm
A group within the trial — "Arm A" might receive the experimental drug, "Arm B" might receive standard care. Most trials have two to four arms.
Primary Endpoint
The main thing the study is measuring — the result that will determine whether the trial succeeded. "Viral load at week 48" is a typical HIV trial primary endpoint.
Adverse Event (AE)
Any medical problem that occurs during the trial — whether or not it's related to the study drug. All AEs must be recorded and reported. Serious adverse events trigger immediate review.
Observational Study
A study where researchers observe and record what happens — without assigning you to any treatment. You just go about your normal care and donate data. Lower burden, lower risk, often paid.
NCT Number
The unique identifier for every registered trial on ClinicalTrials.gov — formatted as NCT followed by eight digits (e.g., NCT05245292). If someone gives you an NCT number, you can paste it directly into the ClinicalTrials.gov search bar to find the exact study.[4]

Clinical trial phases — what they actually mean

Drug development commonly proceeds through phases, but safety continues to be studied in every phase. Later-phase trials have more prior information than first-in-human studies; they still involve risks, uncertainty, and the possibility of no personal benefit.[5]

Phase I
First in humans
Usually a small group. Researchers investigate safety and dosing, sometimes with healthy volunteers and sometimes with people who have the condition. Risks and compensation depend on the particular study.
Phase II
Does it work?
Larger group (100–300). Testing whether the treatment works and what side effects appear. Usually involves PLHIV. More visits, longer duration.
Phase III
Proving it works
Large group (1,000–3,000+). Comparing the new treatment against the current standard. This is where most HIV drug approvals happen.
Phase IV
After approval
Post-market studies of already-approved drugs. Monitoring long-term effects, real-world outcomes, new uses. Lowest risk. Many HIV wellness studies fall here.
Observational
No treatment given
No drug, no intervention. Researchers observe, collect data, or survey. Very common in HIV. Usually the least burdensome type of participation.

The 5 types of HIV clinical trials

HIV trials are not all about cure research or experimental drugs. The range is much broader — and knowing what's out there helps you find what actually fits your situation.

💊
New treatment and regimen studies
Testing new ART drugs, new combinations, simplified regimens, or switching from one regimen to another. Most participants are already virally suppressed on current ART. These trials are often sponsored by pharmaceutical companies and tend to have the most structured compensation.
Examples: Long-acting injectable regimen studies, once-yearly lenacapavir for treatment, regimen simplification trials.
🧬
Cure and remission research
Studies aimed at eliminating HIV from the body or achieving long-term remission without ART. These include broadly neutralizing antibody (bNAb) trials, gene therapy studies, and latency reversal research. Some require an Analytical Treatment Interruption (ATI) — see the ATI section below before considering these.
Examples: bNAb combination studies, CAR-T cell therapy for HIV, kick-and-kill latency reversal trials.
🛡️
Prevention studies
Testing new PrEP formulations or HIV vaccines. Some enroll HIV-negative participants; others enroll PLHIV as participants in vaccine studies aimed at reducing transmission or contributing to functional cure. The PURPOSE trials (lenacapavir for PrEP) are a major recent example.[6]
Examples: New PrEP delivery studies, HIV vaccine trials, prevention intervention research.
❤️
Comorbidity and wellness studies
Research on conditions that disproportionately affect PLHIV — cardiovascular disease, bone density, neurocognitive health, aging, cancer risk, metabolic disorders. These studies typically don't change your HIV regimen and are ideal for people looking to contribute to research without high burden.
Examples: Cardiovascular risk reduction studies, frailty and aging research, doxycycline for emphysema in PLHIV, brain health studies.
📋
Behavioral and care delivery research
Studies on what helps people stay in care, adhere to treatment, access prevention, and improve mental health. Often involve surveys, app-based tools, or counseling sessions rather than medications. Very accessible, usually paid, and often enrolling across many sites including Florida.
Examples: Adherence technology studies, PrEP navigation interventions, mental health and HIV research, care engagement studies.

How to actually find HIV trials

ClinicalTrials.gov is the authoritative source — but you need to know how to use it. Here's the step-by-step approach that cuts through the noise.

🔍 Search ClinicalTrials.gov the right way

Use this exact process to find currently recruiting HIV trials near you:

  1. 1Go to clinicaltrials.gov and click "Find a Study" at the top of the page.
  2. 2In the Condition or disease box, type: HIV
  3. 3In the Country box, select: United States. For Florida studies specifically, also select Florida in the State field.
  4. 4Under Status, check: Recruiting only — this filters out studies that are closed or completed.
  5. 5Click Search. You'll get hundreds of results. Use the filters on the left to narrow by Age, Sex, and Phase.
  6. 6Click any result to see the full listing. Look for "Eligibility Criteria" (do you qualify?) and "Contacts and Locations" (is there a site near you?).
Search HIV Trials Now →
Pro tips for reading results: The title is often unhelpful — read the brief summary instead. "Interventional" means you'll receive something; "Observational" means researchers will observe you. The Estimated Completion Date concerns final study data collection, not the enrollment deadline; ask the site whether it is still recruiting. If a study lists a Florida site but the contact is at a university in another state, you can still call — they often coordinate across sites. If you have an NCT number from a doctor or advocate, paste it directly into the search bar to find the exact trial.

Other ways to find trials

Ask your HIV provider. This is the most underused pathway. Your HIV doctor or the clinic's research coordinator often knows about trials actively recruiting in your area — including ones not easy to find on ClinicalTrials.gov. Ask directly: "Are there any clinical trials you'd recommend I look into?"

Your Ryan White clinic. Many Ryan White-funded HIV clinics are affiliated with research institutions and actively recruit participants. Ask your case manager or clinic coordinator.

Treatment Action Group (TAG). TAG maintains a curated, plain-language list of HIV cure-related clinical trials at treatmentactiongroup.org/cure/trials — updated monthly.[7]

HIVinfo (NIH). The NIH's HIV information service at hivinfo.nih.gov has a clinical trials page and a helpline (1-800-448-0440) where health information specialists can help you find and understand studies.[8]

ResearchMatch. A free NIH-supported tool at researchmatch.org that connects volunteers with researchers — you create a profile and get matched to relevant studies.[9]

Payment varies by study and site. Some offer stipends or reimbursement; others do not. Ask for the amounts, covered expenses, payment schedule, and what happens if you withdraw. The categories below describe questions to ask, not promised payment ranges.[11]

Study typeWhat to ask
Behavioral / observationalWhether interviews, surveys, or travel are compensated.
Comorbidity / wellnessWho pays for research-only scans, blood draws, parking, and routine care.
ART regimen trialsWhether study drugs are supplied and how usual treatment resumes afterward.
Cure / remission researchThe visit burden, transport needs, and risks; payment is not a medical benefit.
Phase I / first-in-humanUnknown risks, time commitments, and payment terms; a larger payment does not mean a safer study.

Tax note: Research payments may be taxable even if you do not receive a tax form. IRS guidance for 2026 generally raises the information-reporting threshold for specified other-income payments to $2,000 from a payer during the calendar year. The form and treatment depend on the payment type; ask the study site what it will report and keep your records.[10]

What compensation is and isn't

Trials are not generally required to pay participants. FDA guidance calls for IRB review of payment amounts and timing to avoid coercion or undue influence. Payment should ordinarily accrue as participation progresses, rather than depend entirely on completing the study.[11]

Sponsors often cover research-only procedures and study drugs, while routine medical care, copays, travel, or other expenses may remain your responsibility. Ask for a written explanation of costs before enrolling.[15]

Clarify any charges before agreeing. A charge alone does not establish that a trial is illegitimate. Ask what your insurer or the sponsor covers, whether an investigational product will be charged for, and whom to contact at the IRB if the explanation is unclear.

How to enroll: step by step

1
Find a trial and read the eligibility criteria
Use ClinicalTrials.gov or one of the other resources above. Read the eligibility section carefully. Don't self-exclude — criteria that seem like they might rule you out often don't. When in doubt, call and ask.
2
Contact the study team
Every trial listing has a Contacts and Locations section with a name, phone number, and/or email for the research coordinator at each site. Call or email. The coordinator's job is to answer your questions — no question is too basic. They'll typically do a brief phone screen to see if you might qualify.
3
Screening visit
If the phone screen goes well, you'll come in for a formal screening visit. This typically includes a physical exam, blood work, review of your medical history, and a chance to ask questions. Ask whether screening visits are compensated and obtain required consent before research-specific screening procedures. Being screened does not obligate you to enroll.
4
Informed consent
If you qualify and want to proceed, you'll go through the informed consent process — a detailed review of what the study involves, all known risks and benefits, your rights, and what happens if you withdraw. This is not a quick signature; a good research team will walk you through every page and answer every question. Take the document home if you want time to review it. Never feel rushed through informed consent.
5
Baseline visit and enrollment
Once consent is signed, you'll have a baseline visit that establishes your starting measurements. This is when you're officially enrolled. Depending on the study design, you may be randomized at this point — meaning you're assigned to a treatment arm.
6
Ongoing participation
Follow the protocol visits and check-ins. Report any health changes or side effects to the research team immediately — this is how the trial data stays clean and how your safety is monitored. The research team is required to update you on any new safety findings that emerge during the study.
7
End of study
When your participation ends, you'll have a closeout visit. Ask about accessing the study results when they're published — you have the right to know what was found. If the experimental treatment worked well, ask about any access programs that may exist while it awaits full approval.

Questions to ask before you sign

Analytical Treatment Interruptions — read this before agreeing

⚠️ This section matters — don't skip it

Some HIV cure research trials — particularly studies testing broadly neutralizing antibodies, immune-based therapies, and latency reversal agents — require participants to temporarily stop taking their ART. This is called an Analytical Treatment Interruption, or ATI.[14]

The purpose of an ATI is scientific: researchers need to see whether an experimental intervention can control HIV replication in the absence of daily medication. You can't measure that while someone is on ART, because the drug is doing the work.

During an ATI, viral load commonly rebounds. The protocol should specify frequent testing, criteria for restarting the complete ART regimen, and urgent contact arrangements. Monitoring schedules differ between studies. Do not stop ART on your own or outside a closely monitored research protocol.

ATIs can cause viral rebound, symptoms, declining CD4 counts, drug resistance, and increased transmission risk. Do not assume U=U remains in effect after stopping treatment: discuss partner protection, including PrEP and condoms, before the interruption. Monitoring reduces some risks but cannot eliminate them.[14]

Questions to ask specifically about ATI studies: How long is the interruption expected to last? What are the viral load and CD4 thresholds that will trigger restarting ART? Will my partner(s) be informed, and how should I handle disclosure? What are the exact risks to my health? What monitoring will occur during the interruption? Has this protocol been done before, and what were the outcomes?

ATI studies may help researchers evaluate remission strategies. They require especially careful discussion of health risks, partner prevention, monitoring, and restart plans under the same informed-consent protections that apply to other research.

Your rights as a trial participant

Federal regulations govern the rights of clinical trial participants.[12] These are not suggestions — they are legal requirements that every legitimate trial must follow.

If something feels wrong: Every trial has an IRB contact — an independent ethics board separate from the research team. If you feel your rights are being violated, your safety is not being monitored appropriately, or you're experiencing pressure you don't know how to handle, you can contact the IRB directly. The IRB contact information should be on your informed consent document. You can also contact the FDA's Office of Good Clinical Practice or the Office for Human Research Protections (OHRP) at HHS.[13]

Florida research sites

Florida has a substantial HIV clinical research infrastructure, concentrated in its major metro areas. If you're in Florida and interested in trial participation, these are the primary institutions with active HIV research programs:

University of Miami / Jackson Health
Miami
One of the largest HIV research programs in the Southeast. Treatment, cure, aging, and comorbidity studies. Major NIH ACTG site.
University of South Florida
Tampa
Active HIV clinical research program. Treatment and wellness studies. Affiliated with Tampa General Hospital.
University of Florida
Gainesville / Jacksonville
HIV research across multiple campuses. Jacksonville campus has a significant HIV care and research program.
Florida International University
Miami
Community-based HIV research with a focus on underserved populations in South Florida.
Orlando Health / AdventHealth
Orlando
Central Florida HIV research sites. Growing research infrastructure, particularly in treatment and prevention.
Broward Health
Fort Lauderdale
Research site serving Broward County's significant HIV population. Community and clinical studies.

To find Florida trials specifically: Use the ClinicalTrials.gov search above and filter by State → Florida. Alternatively, call your Ryan White clinic and ask if they are affiliated with any research programs — many are, and being an established patient often makes you easier to enroll. Your HIV provider may also be a principal investigator on a study you never knew about.

Why community participation matters

HIV clinical research has a diversity problem. Historically, trial populations have been predominantly white, male, and from major metropolitan areas — which means the data on how treatments work in Black and Latino communities, in women, in people over 60, and in rural populations is thinner than it should be. The treatments that emerge from trials need to work for everyone — which means everyone needs to be represented in the research that creates them.

Participating in HIV clinical research is one of the most concrete contributions any PLHIV can make to the epidemic response. Not everyone will qualify, not everyone will be able to commit the time, and not every trial is right for every person. But if you can do it and a trial fits your situation, the contribution is real and lasting.

References & Sources

  1. National Library of Medicine. "ClinicalTrials.gov." The federal registry and results database of publicly and privately supported clinical studies. clinicaltrials.gov ↩
  2. U.S. Food and Drug Administration (FDA). "Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials." fda.gov — IRBs and Protection of Human Subjects ↩
  3. Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. "45 CFR 46 — Protection of Human Subjects (the Common Rule)." hhs.gov/ohrp — 45 CFR 46 Common Rule ↩
  4. ClinicalTrials.gov. "About NCT Numbers." NCT identifiers are assigned to each registered study. clinicaltrials.gov — Protocol Registration ↩
  5. FDA. "Step 3: Clinical Research." Description of Phase 1–4 clinical trials. fda.gov — Step 3: Clinical Research ↩
  6. CDC — Clinical Recommendation for Lenacapavir PrEP (2025), including PURPOSE 1 and PURPOSE 2 results. Source. ↩
  7. Treatment Action Group (TAG). "Research Toward a Cure Trials." Curated, plain-language list of HIV cure trials updated regularly. treatmentactiongroup.org/cure/trials ↩
  8. National Institutes of Health (NIH). "HIVinfo — HIV/AIDS Information Service." HIV clinical trials information and helpline (1-800-448-0440). hivinfo.nih.gov ↩
  9. Vanderbilt University Medical Center / NIH. "ResearchMatch." Free NIH-supported registry connecting volunteers with researchers. researchmatch.org ↩
  10. IRS — Publication 1099 (2026): 2026 information-reporting changes; taxable income is not determined solely by receipt of a form. Source. ↩
  11. FDA — Payment and Reimbursement to Research Subjects (2018). Source. ↩
  12. Office for Human Research Protections (OHRP). "45 CFR 46, Subpart A — Basic HHS Policy for Protection of Human Research Subjects (informed consent, right to withdraw, IRB oversight)." hhs.gov/ohrp — 45 CFR 46 Subpart A ↩
  13. U.S. Department of Health and Human Services. "Office for Human Research Protections (OHRP)." Complaints about research involving human subjects. hhs.gov/ohrp — Compliance and Reporting ↩
  14. NIH — Discontinuation or Interruption of Antiretroviral Therapy: ATI risks and monitoring. Source. ↩
  15. National Cancer Institute — Who Pays for Clinical Trials? Distinguishing research costs from routine care costs. Source. Checked September 20, 2026. ↩
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