The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP
Columbia University
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.
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, and lenacapavir (LEN), a long-acting class capsid inhibitor 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
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.
Location
- Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew York, New York