NCT06868641Recruiting
The TAIL-PrEP Study
The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- 3 Jun 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT06868641
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 3 Jun 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center / NewYork-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.