Health TrialsbyHealthPanel

The TAIL-PrEP Study

ConditionHIV Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Discontinued cab-LAExperimental treatment 1 intervention
Group B: Considering discontinuing cab-LAExperimental treatment 1 intervention
Group C: Considering discontinuing LENExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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