RecruitingNot ApplicableNCT06868641

The TAIL-PrEP Study

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

Sponsor

Columbia University

Enrollment

30 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

HIV Infections

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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
\- Considering discontinuing cab-LA or LEN
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.

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Interventions

BEHAVIORALTAIL-PrEP for patients discontinuing cab-LA

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.

BEHAVIORALTAIL-PrEP for patients considering discontinuing cab-LA

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.

BEHAVIORALTAIL-PrEP for patients considering discontinuing LEN

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.