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HIV Clinical Trials:
The Plain-Language Guide

Last reviewed: September 2026

Educational information only — not medical advice. Talk to your healthcare provider about your specific situation.

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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Every HIV medication you take today — Biktarvy, Descovy, cabotegravir, all of it — exists because thousands of people living with HIV volunteered for clinical trials. Trials are how medicine advances. They are also an opportunity: access to new treatments before they're widely available, free expert medical monitoring, and in many cases meaningful compensation for your time.

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.

Bottom line upfront: HIV clinical trials range from simple blood draw studies to complex multi-year treatment research. Most currently recruiting HIV trials are outpatient, do not require you to stop your current medications, and offer at minimum travel reimbursement — and many pay significantly more. You can ask questions, take time to decide, and leave at any point. Your rights as a participant are protected by federal law.

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.

Every trial is governed by a protocol — a detailed plan spelling out exactly what will happen, to whom, and why. Every trial must be reviewed and approved by an Institutional Review Board (IRB) — an independent ethics committee that evaluates whether the trial is safe, ethical, and scientifically sound before a single participant is enrolled.[2] Every trial must be registered on ClinicalTrials.gov, which is why the database exists.[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. You're entitled to a copy.
Informed Consent
A document — and a process — that explains the study in plain language, including all risks and benefits. You must sign it before enrolling. 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 independent ethics committee that must approve every study before it starts. 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 is how researchers eliminate 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

Drugs move through phases before approval.[5] Most people living with HIV will encounter Phase II, III, or IV trials — the phases where safety has already been established and the research focuses on effectiveness, dosing, and long-term outcomes.

Phase I
First in humans
Small group (20–80 people). Testing safety and dosage for the first time. Highest risk, least known. Often healthy volunteers. Higher compensation.
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 tells you how long they expect to be enrolling. 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]

About 60% of U.S. clinical trials offer some form of compensation to participants. For HIV trials specifically — which are mostly outpatient, Phase II–IV, and focused on people already living with and managing HIV — the compensation picture looks like this:

Trial type Typical compensation What it covers
Behavioral / observational
Surveys, interviews, app-based		 $25–$150 per visit Time stipend. Usually gift cards, prepaid debit, or check. Minimal time commitment.
Comorbidity / wellness studies
Blood draws, imaging, questionnaires		 $50–$300 per visit, $200–$800 total Time + travel. Outpatient. Often parking validated at clinic.
Phase II–III ART regimen trials
Drug effectiveness studies		 $75–$200 per visit, $500–$2,000+ total Time + travel + sometimes study medication provided free. Multiple visits over months or years.
Cure / remission research
bNAbs, CAR-T, ATI studies		 $100–$500+ per visit, $2,000–$8,000+ total Higher compensation for higher time commitment and risk. Frequent monitoring visits. Some require travel to academic medical centers.
Phase I / first-in-human
Rarely involves current PLHIV		 $1,000–$10,000+ Highest compensation for highest unknown risk. Most HIV Phase I trials enroll healthy HIV-negative volunteers or HIV-positive people with specific treatment histories.

Tax note: Clinical trial compensation is taxable income. If you receive $600 or more from a single study in a calendar year, the research institution is required to report it to the IRS and issue you a 1099.[10] Keep track of what you receive. This doesn't mean you shouldn't participate — it just means you should be aware of it.

What compensation is and isn't

Compensation in clinical trials is legally required to be fair payment for time and effort — not an inducement to take risks you wouldn't otherwise take.[11] An IRB reviews every compensation structure before the trial begins to make sure it's not so high that it pressures people into participating against their better judgment. If you find yourself feeling like the money is the only reason you'd do something, that's worth sitting with.

Most HIV trials also provide the study medication free of charge, free lab work as part of the protocol, and free monitoring by expert research clinicians — which has real value independent of any cash compensation.

You should never have to pay to participate in a legitimate clinical trial. If a study asks you to pay for the experimental treatment, that is a major red flag. Legitimate trials do not charge participants.

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. Screening visits are usually compensated. 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.

What this means practically: during an ATI, your viral load will likely rebound. HIV will become detectable in your blood. Your CD4 count may decrease. The research team will monitor you very closely during this period — typically with labs every one to two weeks — and will restart your ART if certain thresholds are crossed.

ATIs carry real risks. Viral rebound can cause acute retroviral syndrome — flu-like symptoms including fever, fatigue, swollen lymph nodes. Elevated viral load means HIV is transmissible again, even if you were previously U=U. CD4 count decreases can, in rare cases, allow opportunistic infections if the interruption goes on too long. The vast majority of ATIs in well-designed trials are time-limited and heavily monitored, with clear stopping rules — but these risks are real and deserve clear-eyed consideration before you say yes.

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 can contribute enormously to cure science — and some participants find the contribution deeply meaningful. But they require a higher level of informed consent than most other HIV trials, and you should take your time before agreeing to one.

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.

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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. Gilead Sciences. "PURPOSE Studies: Lenacapavir for HIV Prevention." Overview of the PURPOSE 1 and PURPOSE 2 pivotal trials of twice-yearly lenacapavir for PrEP. gilead.com/purpose ↩
  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. Internal Revenue Service (IRS). "Instructions for Forms 1099-MISC and 1099-NEC." $600 threshold for reportable payments (Box 3 — Other income). irs.gov — Instructions for 1099-MISC / 1099-NEC ↩
  11. Office for Human Research Protections (OHRP). "Guidance on Payment and Reimbursement to Research Subjects." hhs.gov/ohrp — Payment and Reimbursement Guidance ↩
  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. National Institute of Allergy and Infectious Diseases (NIAID). "HIV Cure Research: Analytical Treatment Interruptions." Overview of ATIs in HIV cure trials, their scientific purpose, and safety considerations. niaid.nih.gov — HIV Cure Research ↩