The TAIL-PrEP Study

NCT06868641 | Not Yet Recruiting

• 2 other identifiers: AAAU70441R21MH133755-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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) 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, which will use cabotegravir drug level monitoring to provide personalized HIV prevention coaching to patients discontinuing long-acting cab-LA. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Conditions

HIV Infections

Keywords

HIV Prevention; PrEP; Cabotegravir; Long-Acting Injectable; Acceptability; Feasibility

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• Adherence to TAIL-PrEP intervention

  6 months

Study Arms (1)

TAIL-PrEP

EXPERIMENTAL

Patients receiving the TAIL-PrEP intervention

Behavioral: TAIL-PrEP

Interventions

TAIL-PrEP BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Have discontinued cab-LA injections within the last three months
• Not currently on cab-LA injections
• HIV-negative (self-report)
• Able to speak and read in English or Spanish,
• Able to receive and send monthly packages
• Have access to an internet-connected device capable of running the Zoom video conferencing platform
• Have a private location at which to take Zoom calls
• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kathrine A Meyers, DrPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrine A Meyers, DrPH

CONTACT

212 304 6110; kam2157@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Bio-Behavioral Sciences

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)