Recruiting

Cabotegravir & Lenacapavir

Sponsor:

Columbia University

Code:

NCT06868641

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TAIL-PrEP for patients discontinuing cab-LA

TAIL-PrEP for patients considering discontinuing cab-LA

TAIL-PrEP for patients considering discontinuing LEN

Study Details

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) 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.

Conditions

HIV Infections

Study ID

NCT06868641

Start date

Jun 3, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 on cab-LA injections
  • Able to receive and send monthly packages
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Discontinued cab-LA

Patients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA

experimental: Considering discontinuing cab-LA

Patients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA

experimental: Considering discontinuing LEN

Patients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN

Interventions

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.

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.

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.

Primary outcome measure

  • Acceptability among Patients [ Time Frame: 6 months ]
  • Feasibility among Patients [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kathrine A Meyers, DrPH

212 304 6110kam2157@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Kathrine A Meyers, DrPH

kam2157@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • HIV Prevention
  • PrEP
  • Cabotegravir
  • Long-Acting Injectable
  • Acceptability
  • Feasibility
  • Lenacapavir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Columbia University on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.