An interventional study of TAIL-PrEP for patients discontinuing cab-LA and TAIL-PrEP for patients considering discontinuing cab-LA in HIV Infections, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
Among 19 studies in HIV Infections by Columbia University — 5 open to participants now, 6 under way, none of them phase 3. HIV Infections · Columbia University.
Among the 19 studies in HIV Infections by Columbia University, this one is the 17th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2026, is one of 14 with no phase, and was the 18th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
Browse HIV Infections studies →5 of the 19 studies in HIV Infections by Columbia University are open now, in 3 countries. Recruiting first, the newest first:
Columbia University · Sites in United States
Columbia University · Sites in Dominican Republic
Columbia University · Sites in South Africa
Columbia University · Sites in United States
By country, each count listing its studies:
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 30 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Median enrollment 153 across the 17 interventional studies, 868 across the 2 observational. Of the 13 that completed or were terminated, 6 (46%) have results posted.
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Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
3 of the studies in HIV Infections by Columbia University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06868641Columbia UniversityThe TAIL-PrEP Study | 2026-12 |
| NCT05633056Columbia UniversityAn Adaptive Randomized Controlled Trial | 2027-04 |
| NCT06853314Columbia UniversityAn Effectiveness Trial of the PrEP for WINGS Study | 2027-06-01 |
Among the 19 studies in HIV Infections by Columbia University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Inclusion criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA
Behavioral: TAIL-PrEP for patients discontinuing cab-LA
Patients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA
Behavioral: TAIL-PrEP for patients considering discontinuing cab-LA
Patients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN
Behavioral: TAIL-PrEP for patients considering discontinuing LEN
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.
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.
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.
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.
Time frame: 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.
Time frame: 6 months
Adherence to TAIL-PrEP intervention
Adherence to the intervention will be assessed by calculating the proportion of intervention components completed out of components possible.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 6 months is below that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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