New Study Seeks Volunteers Who Inject Drugs for HIV Prevention Research with Long-Acting Injectable PrEP

Help Advance HIV Prevention Research: Join a Study on a New Injectable PrEP Medication for People Who Inject Drugs

Are you or someone you know currently injecting drugs and interested in HIV prevention? A groundbreaking clinical study is looking for participants to help researchers evaluate a new long-acting injectable medication that could make HIV prevention easier and more effective.

This study, called Purpose 4, is testing Lenacapavir (LEN)—an investigational injectable PrEP (Pre-Exposure Prophylaxis) medication. The goal? To better understand how this new medication works in people who inject drugs and how it compares to daily PrEP pills like Truvada (F/TDF).

Why This Study Matters

People who inject drugs (PWID) face many challenges, including higher risk of HIV. This study could help bring a more convenient HIV prevention option to those who need it most.

What You Need to Know About the Study

• Study Name: Purpose 4

• Type of Study: Phase 2, open-label, randomized clinical trial

• Location: United States

• Goal: Understand how LEN works in the body and assess its safety compared to Truvada

What’s Involved in the Study?

The study has two phases:

Phase 1 – First Year

• You'll be randomly assigned (like flipping a coin) to:

  • LEN Group: Get an injection under the skin on Day 1 and again 6 months later

  • Truvada Group: Take one tablet by mouth every day

• You won’t get to choose which medication you get

• At least 13 clinic visits over the year

Phase 2 – Open-Label Extension (Optional)

• Everyone who continues will receive LEN injections every 6 months

• Continues until LEN is FDA-approved or the study ends

What Will Happen During Visits?

Your participation includes:

• Physical exams

• Blood and urine tests (including for HIV, STIs, and pregnancy)

• Questionnaires about:

  • Sexual activity

  • Substance use

  • Family planning

  • Intimate partner violence

• Compensation is provided for your time and travel

Am I Eligible?

To join, you must:

• Have a recent urine drug screen positive for opioids, stimulants, or psychoactive drugs

• Show evidence of recent injection (like track marks)

• Report sharing needles or equipment in the past 30 days

• Test negative for HIV and hepatitis B

• Have healthy kidney function

You Cannot Join If You:

• Have ever tested positive for HIV

• Are in another clinical trial that might interfere

• Have taken long-acting PrEP like Cabotegravir before

• Have serious liver issues or active hepatitis

Why You Should Join

By participating, you are:

• Helping researchers develop better, easier ways to prevent HIV

• Contributing to science that directly affects your community

• Getting access to health screenings and care

• Being compensated for your time and travel

Interested in Joining?

If you think you may qualify and want to take part in this important HIV prevention study, reach out today to learn more about how to enroll.

Study Information (Apply)

Help make a difference, for yourself and others. Together, we can move toward a future without HIV.

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