The TAIL-PrEP Study: Supporting Discontinuation of Injectable HIV Prevention

The TAIL-PrEP study aims to find the best ways to help people safely stop using long-acting injectable medications for HIV prevention, specifically cabotegravir (cab-LA) and lenacapavir (LEN). These medications are very effective, but stopping them can be tricky because the drug stays in the body for a while, which could lead to drug resistance if HIV is acquired. This study will test an intervention that includes monthly drug level monitoring and personalized coaching for those stopping cab-LA, or a one-time coaching session for those considering stopping cab-LA or LEN. The goal is to see if this approach is acceptable and practical for patients. You might be able to join if you are at least 18 years old, HIV-negative, speak English, and have internet access for online calls. The study is currently recruiting about 30 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 30 participants. It will assess the acceptability and feasibility of the TAIL-PrEP intervention.
What's involved
For those discontinuing cab-LA, commitments include monthly cab-LA monitoring with self-collected specimens and monthly HIV prevention coaching. For those considering discontinuing cab-LA or LEN, it involves a one-time HIV prevention coaching session.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, acceptability and feasibility, are measured at 6 months.

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NCT06868641

The TAIL-PrEP Study

Recruiting
NAAges 18+InterventionalPrevention
Columbia University
~30 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:TAIL-PrEP for patients discontinuing cab-LATAIL-PrEP for patients considering discontinuing cab-LATAIL-PrEP for patients considering discontinuing LEN

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability among Patients
Measured over 6 months
+1 more outcome measured
HIV Infections
1 sites across 1 states
New York1
  • Kathrine A Meyers, DrPH · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

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
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.
  • Acceptability among Patients6 months

    Acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). AIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The AIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome.

  • Feasibility among Patients6 months

    Feasibility of the intervention will be assessed using the validated Feasibility of Intervention Measure (FIM). FIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The FIM is scored by averaging responses across the 4 items. A higher average score indicates greater feasibility, which is a better outcome.