Improving Treatment Adherence in HIV-Infected Individuals
Changing ART Adherence Behavior: The Lifewindows Project
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized.
Participants in this ~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06030-3212
- University of Connecticut Health Center
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Hartford, Connecticut, Stati Uniti, 06102
- Hartford Hospital
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New Haven, Connecticut, Stati Uniti, 06511
- Hospital of Saint Raphael
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New Haven, Connecticut, Stati Uniti, 06510
- Yale-New Haven Hospital Nathan Smith Clinic
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Waterbury, Connecticut, Stati Uniti, 06708
- Waterbury Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- HIV-infected
- English-speaking
- Currently receiving treatment at one of the participating sites
- Currently receiving antiretroviral therapy
Exclusion Criteria:
- Marked cognitive impairment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Control
Participants will receive the control condition
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At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
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Sperimentale: Intervention
Participants will receive the LifeWindows Intervention sessions
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At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules.
ART adherence promotion intervention activities are tailored to the participant's assessment responses.
Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
Lasso di tempo: Measured at each clinical care visit over 18 months of participation
|
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained. See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266. |
Measured at each clinical care visit over 18 months of participation
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Visual Analog Scale Measure of Adherence to ART
Lasso di tempo: Measured at each clinical visit over 18 months of participation
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This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated. See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77 |
Measured at each clinical visit over 18 months of participation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Viral Load Count
Lasso di tempo: Measured over 18 months
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Viral load data extracted from medical records beginning 30 days prior to baseline.
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Measured over 18 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jeffrey D. Fisher, PhD, University of Connecticut
- Investigatore principale: K. Rivet Amico*, PhD, University of Connecticut (*co-PI)
- Investigatore principale: Deborah H. Cornman*, PhD, University of Connecticut (*co-PI)
- Investigatore principale: William A. Fisher*, PhD, University of Western Ontario (*co-PI)
Pubblicazioni e link utili
Collegamenti utili
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- R01MH066684 (Sovvenzione/contratto NIH degli Stati Uniti)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .