Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Supporting Treatment Adherence Readiness Through Training (START) (START)

5 octobre 2020 mis à jour par: RAND

Controlled Evaluation of the Adherence Readiness Program for ART Adherence

Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial. The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources. Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care. Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year. Secondary outcomes include dose-timing adherence and CD4 count. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.

Type d'étude

Interventionnel

Inscription (Anticipé)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

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

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Most recent HIV viral load is detectable.
  4. If CD4 < 200, the patient is on or will be prescribed prophylactic medication
  5. Patient is 18 or older.
  6. Patient is able and willing to give informed consent.
  7. 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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Glenn Wagner, PhD, RAND

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2015

Achèvement primaire (Réel)

30 mars 2020

Achèvement de l'étude (Réel)

30 mars 2020

Dates d'inscription aux études

Première soumission

22 décembre 2014

Première soumission répondant aux critères de contrôle qualité

31 décembre 2014

Première publication (Estimation)

1 janvier 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 octobre 2020

Dernière vérification

1 octobre 2020

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) ?

Non

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 .

Essais cliniques sur HIV Medication Adherence

Essais cliniques sur Adherence Readiness Program

3
S'abonner