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RECRUITING
NCT06868641
NA

The TAIL-PrEP Study

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-06

Completion Date

2027-03

Last Updated

2026-05-28

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

TAIL-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.

BEHAVIORAL

TAIL-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.

BEHAVIORAL

TAIL-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.

Locations (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States