| NCT ID | NCT06868641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kathrine A Meyers, DrPH
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06868641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06868641 currently recruiting?
Yes, NCT06868641 is actively recruiting participants. Contact the research team at kam2157@cumc.columbia.edu for enrollment information.
Where is the NCT06868641 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06868641 clinical trial?
NCT06868641 is sponsored by Columbia University. The principal investigator is Kathrine A Meyers, DrPH at Columbia University. The trial plans to enroll 30 participants.
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