- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02329782
Supporting Treatment Adherence Readiness Through Training (START) (START)
Controlled Evaluation of the Adherence Readiness Program for ART Adherence
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
Long Beach, California, Stany Zjednoczone
- CaRe Clinic
-
Los Angeles, California, Stany Zjednoczone
- T.H.E. Clinic
-
Los Angeles, California, Stany Zjednoczone
- UCLA CARE Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either
- plans to start the patient on ART
- would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.
Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:
i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.
Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.
- The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
- Most recent HIV viral load is detectable.
- If CD4 < 200, the patient is on or will be prescribed prophylactic medication
- Patient is 18 or older.
- Patient is able and willing to give informed consent.
- English speaking.
Exclusion Criteria:
1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: ARP intervention
Adherence counseling intervention
|
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
|
|
Brak interwencji: usual care
no intervention, standard care practices regarding adherence support
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HIV virologic suppression
Ramy czasowe: Month 24
|
undetectable HIV viral load at time of assessment
|
Month 24
|
|
log change in HIV viral load (log change in HIV RNA levels)
Ramy czasowe: Month 24
|
log change in HIV RNA levels from baseline to Month 24.
|
Month 24
|
|
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Ramy czasowe: Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24
|
Month 24
|
|
percent dose-taking adherence
Ramy czasowe: Month 24
|
percent of prescribed doses taken between baseline and Month 24
|
Month 24
|
|
HIV virologic suppression
Ramy czasowe: Month 6
|
undetectable HIV viral load at time of assessment
|
Month 6
|
|
log change in HIV viral load (log change in HIV RNA levels)
Ramy czasowe: Month 6
|
log change in HIV RNA levels from baseline to Month 6
|
Month 6
|
|
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Ramy czasowe: month 6
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6
|
month 6
|
|
percent dose-taking adherence
Ramy czasowe: month 6
|
percent of prescribed doses taken between baseline and Month 6
|
month 6
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
dose-timing adherence
Ramy czasowe: Month 24
|
percent of prescribed doses taken within correct time-window between baseline and Month 24
|
Month 24
|
|
dose-timing adherence
Ramy czasowe: Month 6
|
percent of prescribed doses taken within correct time-window between baseline and Month 6
|
Month 6
|
|
optimal dose-timing adherence
Ramy czasowe: Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24
|
Month 24
|
|
optimal dose-timing adherence
Ramy czasowe: Month 6
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6
|
Month 6
|
|
change in CD4 count
Ramy czasowe: Month 24
|
change in CD4 count from baseline to Month 24
|
Month 24
|
|
change in CD4 count
Ramy czasowe: Month 6
|
change in CD4 count from baseline to Month 6
|
Month 6
|
|
clinic attendance (number of missed clinic appointments)
Ramy czasowe: Month 24
|
number of missed clinic appointments between baseline and Month 24
|
Month 24
|
|
clinic attendance (number of missed clinic appointments)
Ramy czasowe: Month 6
|
number of missed clinic appointments between baseline and Month 6
|
Month 6
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Glenn Wagner, PhD, RAND
Publikacje i pomocne linki
Publikacje ogólne
- Wagner GJ, Seelam R, Hoffman R, Ghosh-Dastidar B. Mediators and moderators of ART adherence effects of supporting treatment adherence readiness through training (START): evidence that START helps vulnerable clients achieve better adherence. AIDS Care. 2022 Oct;34(10):1249-1256. doi: 10.1080/09540121.2021.2006133. Epub 2021 Nov 21.
- Wagner GJ, Hoffman R, Linnemayr S, Schneider S, Ramirez D, Gordon K, Seelam R, Ghosh-Dastidar B. START (Supporting Treatment Adherence Readiness through Training) Improves Both HIV Antiretroviral Adherence and Viral Reduction, and is Cost Effective: Results of a Multi-site Randomized Controlled Trial. AIDS Behav. 2021 Oct;25(10):3159-3171. doi: 10.1007/s10461-021-03188-x. Epub 2021 Apr 2.
- Wagner GJ, Linnemayr S, Ghosh-Dastidar B, Currier JS, Hoffman R, Schneider S. Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:162. doi: 10.1186/s13063-016-1287-3.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- MH104086
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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