- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02329782
Supporting Treatment Adherence Readiness Through Training (START) (START)
Controlled Evaluation of the Adherence Readiness Program for ART Adherence
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Long Beach, California, États-Unis
- Care Clinic
-
Los Angeles, California, États-Unis
- T.H.E. Clinic
-
Los Angeles, California, États-Unis
- UCLA CARE Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
|
Aucune intervention: usual care
no intervention, standard care practices regarding adherence support
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
HIV virologic suppression
Délai: Month 24
|
undetectable HIV viral load at time of assessment
|
Month 24
|
log change in HIV viral load (log change in HIV RNA levels)
Délai: 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)
Délai: 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
Délai: Month 24
|
percent of prescribed doses taken between baseline and Month 24
|
Month 24
|
HIV virologic suppression
Délai: Month 6
|
undetectable HIV viral load at time of assessment
|
Month 6
|
log change in HIV viral load (log change in HIV RNA levels)
Délai: 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)
Délai: 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
Délai: month 6
|
percent of prescribed doses taken between baseline and Month 6
|
month 6
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
dose-timing adherence
Délai: Month 24
|
percent of prescribed doses taken within correct time-window between baseline and Month 24
|
Month 24
|
dose-timing adherence
Délai: Month 6
|
percent of prescribed doses taken within correct time-window between baseline and Month 6
|
Month 6
|
optimal dose-timing adherence
Délai: 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
Délai: 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
Délai: Month 24
|
change in CD4 count from baseline to Month 24
|
Month 24
|
change in CD4 count
Délai: Month 6
|
change in CD4 count from baseline to Month 6
|
Month 6
|
clinic attendance (number of missed clinic appointments)
Délai: Month 24
|
number of missed clinic appointments between baseline and Month 24
|
Month 24
|
clinic attendance (number of missed clinic appointments)
Délai: Month 6
|
number of missed clinic appointments between baseline and Month 6
|
Month 6
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Glenn Wagner, PhD, RAND
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- MH104086
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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