- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00130273
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV (MAPS)
Managed Problem Solving: An HIV Adherence Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
HAART is considered to be the most effective treatment for HIV. However, sustained and consistent adherence to HAART is necessary for long-term success. Issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to HAART. This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV. Both treatment-naive and treatment-experienced participants will be recruited for this study.
The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria for All Participants:
- HIV infected
- Infection likely to be susceptible to a specific treatment regimen
- Have access to a telephone
- Willing and able to comply with all study requirements
Exclusion Criteria for All Participants:
- Live in a care facility that provides medications on schedule
Inclusion Criteria for Treatment-Experienced Participants:
- Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
- On a treatment regimen for less than 2 weeks prior to study entry
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
Participants will receive managed problem solving for 12 months
|
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months.
At each study visit, participants will identify barriers to adherence.
During the phone calls, participants will be asked about any steps they have taken to improve their adherence.
A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence.
MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings.
Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes.
Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
|
|
Comparatore attivo: 2
Participants will receive standard of care for 12 months
|
Participants will receive standard of care for 12 months.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Improved adherence
Lasso di tempo: Measured at Year 4
|
Measured at Year 4
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Decrease in viral load
Lasso di tempo: Measured at Year 4
|
Measured at Year 4
|
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Increase in CD4 count
Lasso di tempo: Measured at Year 4
|
Measured at Year 4
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Robert Gross, MD, MSCE, University of Pennsylvania
Pubblicazioni e link utili
Studiare le date dei record
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
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- R01MH067498 (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 .