HIV InfectionsNCT06868641
The TAIL-PrEP Study
A study testing TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA and TAIL-PrEP for patients considering discontinuing LEN in people with HIV Infections, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA and TAIL-PrEP for patients considering discontinuing LEN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Kathrine A Meyers, DrPH, kam2157@cumc.columbia.edu
About this study
Official title: The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP
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.
Read the 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, and lenacapavir (LEN), a long-acting class capsid inhibitor 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. LEN does not pose the same issue with a drug tail during discontinuation, but patients discontinuing LEN may need guidance on how to switch to other HIV prevention strategies rather than discontinuing HIV prevention altogether. 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
- Being tested
- TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN
- Keywords
- HIV Prevention, PrEP, Cabotegravir, Long-Acting Injectable, Acceptability, Feasibility, Lenacapavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAIL-PrEP for patients discontinuing cab-LABehavioural
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-LABehavioural
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 LENBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Discontinued cab-LA | Experimental | Patients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA Receives: Behavioral: TAIL-PrEP for patients discontinuing cab-LA |
| Considering discontinuing cab-LA | Experimental | Patients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA Receives: Behavioral: TAIL-PrEP for patients considering discontinuing cab-LA |
| Considering discontinuing LEN | Experimental | Patients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN Receives: Behavioral: TAIL-PrEP for patients considering discontinuing LEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability among Patients
Acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). AIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The AIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome.
Measured: 6 months
Feasibility among Patients
Feasibility of the intervention will be assessed using the validated Feasibility of Intervention Measure (FIM). FIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The FIM is scored by averaging responses across the 4 items. A higher average score indicates greater feasibility, which is a better outcome.
Measured: 6 months
Secondary outcomes (1)
Adherence to TAIL-PrEP intervention
Adherence to the intervention will be assessed by calculating the proportion of intervention components completed out of components possible.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start3 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathrine Meyers, Columbia University
- Investigators
- Kathrine A Meyers, DrPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868641
- Sponsor's protocol ID
- AAAU7044
- Other IDs
- 1R21MH133755-01
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP
- ClinicalTrials.gov ID
- NCT06868641
- Acronym / sponsor ID
- AAAU7044
- Conditions
- HIV Infections
- Keywords
- HIV Prevention, PrEP, Cabotegravir, Long-Acting Injectable, Acceptability, Feasibility, Lenacapavir
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, and lenacapavir (LEN), a long-acting class capsid inhibitor 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. LEN does not pose the same issue with a drug tail during discontinuation, but patients discontinuing LEN may need guidance on how to switch to other HIV prevention strategies rather than discontinuing HIV prevention altogether. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Discontinued cab-LA | Experimental | Behavioral: TAIL-PrEP for patients discontinuing cab-LAPatients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA |
| Considering discontinuing cab-LA | Experimental | Behavioral: TAIL-PrEP for patients considering discontinuing cab-LAPatients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA |
| Considering discontinuing LEN | Experimental | Behavioral: TAIL-PrEP for patients considering discontinuing LENPatients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAIL-PrEP for patients discontinuing cab-LAThe 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. | Behavioural | Discontinued cab-LA |
| TAIL-PrEP for patients considering discontinuing cab-LAThe 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. | Behavioural | Considering discontinuing cab-LA |
| TAIL-PrEP for patients considering discontinuing LENThe TAIL-PrEP intervention is comprised of a one-time HIV prevention coaching session to guide patients considering discontinuing LEN on their HIV prevention options. | Behavioural | Considering discontinuing LEN |
Primary outcome
Acceptability among Patients
Time frame: 6 months
Acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). AIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The AIM is scored by averaging responses across the 4 items. A higher average score indicates greater acceptability, which is a better outcome.
Feasibility among Patients
Time frame: 6 months
Feasibility of the intervention will be assessed using the validated Feasibility of Intervention Measure (FIM). FIM is a 4-item scale where respondents rate each item using a 5-point ordinal scale that ranges from 1="completely disagree" to 5="completely agree". The FIM is scored by averaging responses across the 4 items. A higher average score indicates greater feasibility, which is a better outcome.
1 secondary outcome
Adherence to TAIL-PrEP intervention
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathrine A Meyers, DrPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA and TAIL-PrEP for patients considering discontinuing LEN in people with HIV Infections, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathrine A Meyers, DrPH (212 304 6110, kam2157@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability among Patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.