NCT06868641

The TAIL-PrEP Study

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) 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, which will use cabotegravir drug level monitoring to provide personalized HIV prevention coaching to patients discontinuing long-acting cab-LA. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Detailed description

Oral PrEP is highly effective but underutilized, with only 25% of individuals eligible for PrEP in the US having a prescription. Recent approval of cabotegravir-LA (cab-LA), a long-acting injectable integrase inhibitor and the first long-acting injectable PrEP, presents an opportunity to increase uptake. However, the long and variable half-life of cab-LA across different individuals after discontinuation (called the "tail") poses an implementation challenge. During the tail, cabotegravir levels are sub-therapeutic but could select for integrase-inhibitor resistance if the patient were to acquire HIV. This concern about the tail presents a barrier to providers prescribing cab-LA, potentially limiting the contribution of cab-LA to achieving End the HIV Epidemic targets and PrEP uptake and HIV infection. Currently, to mitigate this risk, individuals are advised to use oral PrEP for up to and beyond 12 months after stopping cab-LA injections if they have an ongoing risk of becoming infected with HIV. However, a risk mitigation strategy that requires daily oral PrEP may not be feasible or acceptable to many patients who started injectable PrEP precisely because they were unable or unwilling to adhere to a daily medication. The goal of the TAIL-PrEP study is to pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention, which will use cabotegravir drug levels measured in blood specimens to provide personalized feedback and HIV prevention coaching (Aim 1); and refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study (Aim 2).

Conditions

• HIV Infections

Interventions

Type	Name	Description
BEHAVIORAL	TAIL-PrEP	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-08-01
• Completion: 2027-03-01
• First posted: 2025-03-11
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States