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The TAIL-PrEP Study

Columbia University · with National Institute of Mental Health (NIMH) · NCT06868641

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
June 3, 2026
Record last updated
September 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Being studied: TAIL-PrEP for patients discontinuing cab-LA; TAIL-PrEP for patients considering discontinuing cab-LA; TAIL-PrEP for patients considering discontinuing LEN

Conditions: HIV Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    New York, NY 10032

    Site contact: Kathrine A Meyers, DrPH · kam2157@cumc.columbia.edu

Study contacts (from the official record)

  • Kathrine A Meyers, DrPH · 212 304 6110 · kam2157@cumc.columbia.edu
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The TAIL-PrEP Study (NCT06868641) | Bored Studies