Clinical trial NCT06868641: The TAIL-PrEP Study
Official title: The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
PrEP
Cabotegravir
Long-Acting Injectable
Acceptability
Feasibility
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion criteria:

* At least 18 years of age
* Have discontinued cab-LA injections within the last three months
* Not currently on cab-LA injections
* HIV-negative (self-report)
* Able to speak and read in English or Spanish,
* Able to receive and send monthly packages
* Have access to an internet-connected device capable of running the Zoom video conferencing platform
* Have a private location at which to take Zoom calls

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.

Primary outcomes:
measure: Acceptability among Patients
timeFrame: 6 months
measure: Feasibility among Patients
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to TAIL-PrEP intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Kathrine A Meyers, DrPH
role: PRINCIPAL_INVESTIGATOR
References: