PURPOSE 4: Could an Investigational Twice-a-Year Injection Prevent HIV?
Our team of clinical scientists are evaluating an investigational PrEP (pre-exposure prophylaxis) medicine, lenacapavir, to see if it helps to reduce the chance of getting HIV through sex and through sharing of injection equipment. This clinical trial is supported by, and in partnership with, the HIV Prevention Trials Network (HPTN) and is one of the many trials working to expand global HIV prevention efforts.
Some participants in the study will receive the investigational medicine, which is given as an injection under the skin once every 6 months. Other participants in the study will receive daily emtricitabine/tenofovir disoproxil fumarate (also known as F/TDF or Truvada®) taken by mouth. The study drug you receive may be lenacapavir (2 out of 3 chance) or F/TDF (1 out of 3 chance).
Do you qualify?What Does the Study Involve?
You will first come into the participating site where you will be asked to review and sign an informed consent form. During the initial visit you will have an HIV test and other lab tests done and be asked more questions by the staff to see if you meet all the eligibility criteria for the study. If you do not have HIV and meet all the eligibility criteria, you may be able to enroll in the study. If you are confirmed to have HIV, we will help you find HIV care in your community.
You will not be required to stop using drugs if you choose to enroll in this study. Participants will be provided harm reduction supplies, if allowed by local laws, and overdose prevention counseling. We can help connect you to treatment options if you are interested in stopping or reducing your use.
This study will last approximately 2.5 years.
The visits are 4-13 weeks apart, with 4-8 visits per year.
Everyone who enrolls in the study will receive either a daily pill or an injection given every 6 months.
- Which drug you receive will be determined by chance
- The active drug you receive may be lenacapavir (2 out of 3 chance) or F/TDF (1 out of 3 chance)
- When the first part of the study is over, you will transition to the second phase of the study where everyone receives daily oral F/TDF
You will first come into the participating site where you will be asked to review and sign an informed consent form. During the initial visit you will have an HIV test and other lab tests done and be asked more questions by the staff to see if you meet all the eligibility criteria for the study. If you do not have HIV and meet all the eligibility criteria, you may be able to enroll in the study. If you are confirmed to have HIV, we will help you find HIV care in your community.
You will not be required to stop using drugs if you choose to enroll in this study. Participants will be provided harm reduction supplies, if allowed by local laws, and overdose prevention counseling. We can help connect you to treatment options if you are interested in stopping or reducing your use.
This study will last approximately 2.5 years.
The visits are 4-13 weeks apart, with 4-8 visits per year.
Everyone who enrolls in the study will receive either a daily pill or an injection given every 6 months.
- Which drug you receive will be determined by chance
- The active drug you receive may be lenacapavir (2 out of 3 chance) or F/TDF (1 out of 3 chance)
- When the first part of the study is over, you will transition to the second phase of the study where everyone receives daily oral F/TDF
PURPOSE 4 Questionnaire
Thank you for your interest in participating in the PURPOSE 4 study.
Answer these 4 questions to see if you may be eligible to take part in the study:
You may qualify!
If you want to learn more about participating in PURPOSE 4, use our site finder to contact a study site in your area.
Find a study siteYou may not qualify, but there are still ways you can help!
You can still help us in our mission by sharing our PURPOSE 4 study with others.
Find a study site PURPOSE 4 informationYour privacy matters to us. Note that your answers will only be used to let you know whether or not you qualify, and will not be stored or tracked in any way.
