Improving Treatment Adherence in HIV-Infected Individuals
Changing ART Adherence Behavior: The Lifewindows Project
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
-
Connecticut
-
Farmington, Connecticut, Spojené státy, 06030-3212
- University of Connecticut Health Center
-
Hartford, Connecticut, Spojené státy, 06102
- Hartford Hospital
-
New Haven, Connecticut, Spojené státy, 06511
- Hospital of Saint Raphael
-
New Haven, Connecticut, Spojené státy, 06510
- Yale-New Haven Hospital Nathan Smith Clinic
-
Waterbury, Connecticut, Spojené státy, 06708
- Waterbury Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- HIV-infected
- English-speaking
- Currently receiving treatment at one of the participating sites
- Currently receiving antiretroviral therapy
Exclusion Criteria:
- Marked cognitive impairment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Control
Participants will receive the control condition
|
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.
|
|
Experimentální: Intervention
Participants will receive the LifeWindows Intervention sessions
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
Časové okno: 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
|
|
Visual Analog Scale Measure of Adherence to ART
Časové okno: Measured at each clinical visit over 18 months of participation
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Viral Load Count
Časové okno: Measured over 18 months
|
Viral load data extracted from medical records beginning 30 days prior to baseline.
|
Measured over 18 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jeffrey D. Fisher, PhD, University of Connecticut
- Vrchní vyšetřovatel: K. Rivet Amico*, PhD, University of Connecticut (*co-PI)
- Vrchní vyšetřovatel: Deborah H. Cornman*, PhD, University of Connecticut (*co-PI)
- Vrchní vyšetřovatel: William A. Fisher*, PhD, University of Western Ontario (*co-PI)
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- R01MH066684 (Grant/smlouva NIH USA)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .