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The TAIL-PrEP Study

Sponsor: Columbia University • ClinicalTrials.gov ID: NCT06868641

Registry updated: 2026-09-21

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Description

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.

Interventions

TAIL-PrEP for patients discontinuing cab-LA (Behavioral)
The TAIL-PrEP intervention is comprised of two components: (1) monthly cab-LA monitoring with specimens self-collected by patient and mailed to a lab for processing; and (2) monthly HIV prevention coaching with personalized cab-LA feedback.
TAIL-PrEP for patients considering discontinuing cab-LA (Behavioral)
The TAIL-PrEP intervention is comprised of a one-time HIV prevention coaching session to guide patients considering discontinuing cab-LA on their HIV prevention options.
TAIL-PrEP for patients considering discontinuing LEN (Behavioral)
The TAIL-PrEP intervention is comprised of a one-time HIV prevention coaching session to guide patients considering discontinuing LEN on their HIV prevention options.

Eligibility 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.

Conditions

HIV Infections

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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