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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: TAIL-PrEP for patients discontinuing cab-LA for HIV Infections

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session.

Official registry: https://clinicaltrials.gov/study/NCT06868641 · Columbia University · enrollment listed as 30

What this phase means

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 TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, or TAIL-PrEP for patients considering discontinuing LEN. The registry lists allocation as randomized. The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions.

They plan to enroll about 30 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP

Interventions: TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN

Primary outcome (registry wording): Acceptability among Patients

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • At least 18 years of age
  • HIV-negative (self-report)
  • Able to speak and read in English
  • Have access to an internet-connected device capable of running the online video conferencing platform
  • Have a private location at which to take online conference calls
  • Participants considering discontinuing cab-LA or LEN have the following additional who can join:
  • \- Considering discontinuing cab-LA or LEN

Public study contact (from the registry)

Kathrine A Meyers, DrPH

212 304 6110

kam2157@cumc.columbia.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06868641 still recruiting?

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 NCT06868641?

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 NCT06868641?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary