The TAIL-PrEP Study

Columbia University

Status

Not yet enrolling

Conditions

HIV Infections

Treatments

Behavioral: TAIL-PrEP

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06868641

1R21MH133755-01 (U.S. NIH Grant/Contract)

AAAU7044

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.