The TAIL-PrEP Study

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• TAIL-PrEP for patients discontinuing cab-LA — 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 for patients considering discontinuing cab-LA — BEHAVIORAL
  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 LEN — BEHAVIORAL
  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 Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Discontinued cab-LA
  Patients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA
• Experimental: Considering discontinuing cab-LA
  Patients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA
• Experimental: Considering discontinuing LEN
  Patients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN

Primary Outcome Measure

Acceptability among Patients [ Time Frame: 6 months ]

Central Contacts

• Kathrine A Meyers, DrPH
  212 304 6110
  [email protected]

Locations (1)

Find similar trials in New York, NY

Related Studies

• WiseApp for Spanish Speakers Living With HIV
  Recruiting · Columbia University · New York, New York
• Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
  Enrolling By Invitation · Hunter College of City University of New York · Ann Arbor, Michigan
• Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
  Recruiting · Hunter College of City University of New York · Detroit, Michigan
• Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
  PHASE1 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California