Lo studio di coda-prep
Lo studio di coda prep: accettabilità e fattibilità di un intervento di aderenza su misura per una sospensione sicura della preparazione a lunga durata
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kathrine A Meyers, DrPH
- Numero di telefono: 212 304 6110
- Email: kam2157@cumc.columbia.edu
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Reclutamento
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
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Contatto:
- Kathrine A Meyers, DrPH
- Email: kam2157@cumc.columbia.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- 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:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Discontinued cab-LA
Patients who recently discontinued cab-LA who receive the TAIL-PrEP intervention for patients who discontinued cab-LA |
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. |
|
Sperimentale: Considering discontinuing cab-LA
Patients who are considering discontinuing cab-LA who receive the TAIL-PrEP intervention for patients considering discontinuing cab-LA |
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. |
|
Sperimentale: Considering discontinuing LEN
Patients who are considering discontinuing LEN who receive the TAIL-PrEP intervention for patients considering discontinuing LEN |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Acceptability among Patients
Lasso di tempo: 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. |
6 months
|
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Feasibility among Patients
Lasso di tempo: 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. |
6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adherence to TAIL-PrEP intervention
Lasso di tempo: 6 months
|
Adherence to the intervention will be assessed by calculating the proportion of intervention components completed out of components possible. |
6 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kathrine A Meyers, DrPH, Columbia University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni a trasmissione ematica
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema immunitario
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Infezioni da HIV
Altri numeri di identificazione dello studio
- AAAU7044
- 1R21MH133755-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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