Tail-PrEP: Safe, guided stopping of long-acting PrEP with coaching and monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TAIL-PrEP explores a practical approach to stopping long-acting HIV prevention injections by using personalized coaching and monthly drug-level checks to support safer discontinuation. The study will pilot two arms: one for people stopping cabotegravir and one for those considering stopping cabotegravir or lenacapavir, with a focus on feasibility and acceptability. Based on findings, the team will refine the intervention and implementation strategy to improve real-world use and public health impact. The goal is to balance stopping injections with maintaining protection against HIV during the tail period after cessation.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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 inclusion criteria:

\- Considering discontinuing cab-LA or LEN

Participants discontinuing cab-LA have the following additional inclusion criteria:

* Have discontinued cab-LA injections within the last three months
* Not currently on cab-LA injections
* Able to receive and send monthly packages
* The study period will end for patient participants once the monthly blood draw result indicates that cab-LA levels are not detectable (estimated average of 6 months across all patients) or after 6 months of the study, whichever comes first. If at 6 months of study participation, cab-LA levels are still detectable and participants adhered to at least 50% of study activities (self-collecting and mailing monthly blood samples, completing monthly surveys, attending monthly coaching sessions), participants will be invited to participate in the study for an additional 6 months, for a total of up to 12 study visits.

Where it's running

• Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kathrine A Meyers, DrPH — Columbia University
• Study coordinator: Kathrine A Meyers, DrPH
• Email: kam2157@cumc.columbia.edu
• Phone: 212 304 6110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.