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Medication Adherence in Human Immunodeficiency Virus (HIV)

1 août 2016 mis à jour par: St. Jude Children's Research Hospital

Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)

Although effective treatments are currently available to treat human immunodeficiency virus (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy (HAART) regimens is well documented in individuals with HIV. This is especially true for adolescents and young adults (AYA), where rates of adherence range from 20 to 100%. Nonadherence has significant implications for subsequent treatment response and health outcomes, including poor virologic response, development of drug resistance, and mortality. Of note, previous research has suggested that every 1% increase in nonadherence is related to a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus transmission. Thus, nonadherence to HAART is a significant public health issue.

The objective of the proposed research plan is to systematically examine an individualized, behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current intervention will support AYA participation in brief, staff-delivered instruction in adherence-promotion skills. Individualized behavioral analysis and motivational interviewing will be applied to provide effective solutions for current barriers to HAART adherence before and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for Adults and Adolescents.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The proposed pilot study will utilize a randomized controlled trial to estimate the feasibility, acceptability, and preliminary efficacy of a novel intervention for AYAs diagnosed with behaviorally-acquired HIV initiating HAART.

Standard care for HIV at St. Jude Children's Research Hospital (SJCRH) includes a placebo pill trial to assess patient readiness for therapy prior to starting HAART. Participants on this study will be randomized to either: a control arm of standard therapy, or standard therapy plus an individualized behavioral, staff-delivered intervention (Pill Trial+).

Participants in the control arm will receive standard clinical care. Participants in the Pill Trial+ arm will receive standard therapy plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits. Two brief booster sessions will also be provided to the Pill Trial+ arm following sessions 1 (in clinic) and 2 (by phone). In-person intervention sessions and all questionnaires will be completed in conjunction with scheduled clinical care visits. Sessions and measures will be completed by phone at designated time points if a participant becomes unavailable to return to clinic due to extenuating circumstances.

As recommended by Panel guidelines, discussion of placebo pill trial adherence during the first 25-minute session will provide a novel mechanism to discuss barriers to adherence and provide intervention prior to HAART initiation. Remaining sessions will promote adherence following HAART initiation using behavioral problem-solving and motivational interviewing strategies.

Primary Objective:

  • To estimate a) rate of consent to the randomized trial and b) differences between the intervention and control conditions with respect to HAART adherence, as measured by pill count.

Secondary Objectives:

  • To estimate differences between the intervention and control conditions with respect to other measures of adherence, including HAART self-reported adherence, HAART pharmacy refill, and clinic attendance.
  • To examine disease and patient-reported outcomes during the first 6 months following HAART initiation and their relationship to participation in the Pill Trial+ intervention.

Type d'étude

Interventionnel

Inscription (Réel)

33

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

  • États-Unis
    • Tennessee
      • Memphis, Tennessee, États-Unis, 38105
        • St. Jude Children's Research Hospital

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

13 ans à 24 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Behaviorally acquired HIV diagnosis, confirmed via medical chart review.
  • Currently followed in the St. Jude Children's Research Hospital (SJCRH) HIV clinic.
  • Initiating HAART.
  • Recommended a placebo trial.
  • 13-24 years of age at time of study entry.
  • If 15 years of age or over, willing to give informed consent. If under the age of 15, willing to give assent and accompanied by legal guardian/representative to give informed consent.
  • Fluent in English

Exclusion Criteria:

  • Previous HAART exposure.
  • Unable to understand English and/or not cognitively intact (known IQ < 70) such that the study questionnaires cannot be understood and completed.
  • Pregnant female.
  • Enrolled on another protocol that excludes participation in this study.

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: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Standard Care
Participants in the Standard Care group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study. They will receive standard clinical care.
Autre: Demographic Questionnaire
Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Autre: Questionnaires
Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
Expérimental: Pill Trial+
Participants in the Pill Trial+ group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study. They will receive standard clinical care plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits. Two brief booster sessions will also be provided following sessions 1 (in clinic) and 2 (by phone).
Autre: Demographic Questionnaire
Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Autre: Questionnaires
Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
Comportemental: Staff-delivered intervention sessions
In addition to standard clinical care, participants in the Pill Trial+ arm will receive staff-delivered intervention sessions individualized for each participant at HAART initiation, 1-month, and 3-month follow-up. Two booster sessions will also be provided at two weeks following intervention session 1 (in clinic) and intervention session 2 (by phone) to assess any difficulties using the created adherence plans.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of consent to trial participation
Délai: Day 1
Day 1
Pill count values compared between arms
Délai: 3 months post-HAART initiation
Using Fisher Exact tests
3 months post-HAART initiation
Pill count values compared between arms
Délai: 6 months post-HAART initiation
Using Fisher Exact tests
6 months post-HAART initiation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Adherence rates compared between groups
Délai: 3 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Fisher exact tests will be performed to compare adherence rates between groups.
3 months post-HAART initiation
Patient outcome
Délai: 6 months following HAART initiation
Disease and patient-reported outcomes will be examined as well as their relationship to participation in the Pill Trial+ intervention. Viral load (VL), CD4 count/%, health-related quality of life (HRQOL) scores, and beliefs about medication (BAM) scores will be analyzed. Mixed effects models will be employed to explore the efficacy of the intervention on virologic response, HRQOL, and medical beliefs. VL, CD4 count/%, HRQOL, and beliefs will be used as the response variables, respectively, while time since treatment, intervention, and their interaction will be included as covariates.
6 months following HAART initiation
Adherence rates compared between groups
Délai: 6 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Fisher exact tests will be performed to compare adherence rates between groups.
6 months post-HAART initiation
Change in adherence rates compared between groups
Délai: Baseline through 6 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Mixed effects models and logistic link will be used to examine differences between groups adherence data and within-subject changes in adherence over time.
Baseline through 6 months post-HAART initiation

Collaborateurs et enquêteurs

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

Parrainer

St. Jude Children's Research Hospital

Les enquêteurs

  • Chercheur principal: Megan Wilkins, PhD, St. Jude Children's Research Hospital

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.

Publications générales

Liens utiles

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

1 avril 2014

Achèvement primaire (Réel)

1 juillet 2016

Achèvement de l'étude (Réel)

1 juillet 2016

Dates d'inscription aux études

Première soumission

15 avril 2014

Première soumission répondant aux critères de contrôle qualité

17 avril 2014

Première publication (Estimation)

21 avril 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 août 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 août 2016

Dernière vérification

1 juillet 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P1TEAM

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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