Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite
Not a traditional drug phase: Choice of follow up for HIV Pre-exposure Prophylaxis Use
PrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Choice of follow up, or Follow up via standard clinic. The registry lists allocation as randomized. PrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.
They plan to enroll about 400 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
Interventions: Choice of follow up, Follow up via standard clinic
Primary outcome (registry wording): PrEP persistence at 6 months
Who it is for (from inclusion criteria)
Ages 18 Years to any
Eligible for HIV PrEP per CDC guidelines
Willing to receive injectable lenacapavir and adhere to study procedures
Residing inMassachusetts with expected availability for 6-month follow-up
Who the registry excludes
Known HIV infection at baseline
Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)
Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)
Participation in another treatment HIV prevention study
Any condition judged by the investigator to compromise safety or study integrity
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART).
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07335289?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07335289?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.