- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01409655
Centralized Off-Site Adherence Enhancement Program (CARE)
23. februar 2016 oppdatert av: Honghu Liu, University of California, Los Angeles
Our proposal "Centralized Off-Site Adherence Enhancement Program" or "CARE" will develop and test an effective behavioral adherence intervention program for HIV patients with alcohol and/or substance abuse problems.
This project will develop and pilot test a novel program to help patients with alcohol and/or substance abuse problems take their medications as prescribed.
The intervention will be delivered by phone, and utilize electronic monitoring of medication-taking, so patients can be treated by therapists from any geographic distance.
To safely monitor data collected for this study, we have laid out a detailed Data Safety Monitoring Plan, which will cover all the issues required by NIDA.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients who use drugs or alcohol who do not adequately adhere to antiretroviral medication have sub-optimal outcomes, but effective interventions for them are lacking.
In this R34 application, we seek to develop and pilot an intervention program delivered by phone and supported by information technology that combines contingency management for medication adherence and a cognitive-behavioral approach to both adherence to antiretroviral therapy and abstinence from substances of abuse.
The intervention, CARE (Centralized Off-site AdheRence Enhancement Program), builds on the published finding that adherence was robustly improved and viral load was significantly reduced among patients who received cash-reinforcement for opening MEMS-capped bottles to take prescribed medication on time.
CARE involves transmission of bottle-opening data with real time operation from SimPill bottles to a website system which generates messages to patients indicating the amount of cash-reinforcement earned if medication was taken within a specified time window or forsaken if medication was missed.
Reinforcement for medication-taking will be wired to debit cards that patients will be given to receive the payments.
This contingent reinforcement of medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT) conducted by phone, also assisted by the website which will generate CBT-related text messages, reminders and scheduling information from a menu of choices negotiated by the patient and therapist.
Development of CARE will proceed in three stages, with revisions of the intervention at each stage.
First, the web system and therapy manuals will be developed.
Second, twelve weeks of CARE will be pre-piloted in 10 patients with sub-optimal adherence and recent risky alcohol use and/or stimulant misuse.
Qualitative and quantitative data will be collected concerning acceptability, usability and perceived efficacy of components of CARE; Procedures and logistics will be evaluated, and modified, if necessary.
Third, CARE will be pilot-tested in a twelve-week randomized controlled trial in which the control arm only involves phone-based counseling focusing first on adherence and then on abstinence.
Retention of effects will be examined during a twelve-week follow-up period.
CARE has the potential to be among the first interventions that delivers both reinforcement and counseling remotely, that improves outcomes among substance users without providing opioid substitution or other extremely intensive interventions, and that utilizes a cognitive-behavioral approach targeting both non-adherence and substance abuse.
Because CARE is delivered by a therapist who is off-site from the patient's clinic, CARE can be effectively delivered from any distance and is a scalable treatment for patients in whom medication adherence is crucial.
Studietype
Intervensjonell
Registrering (Faktiske)
42
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Los Angeles, California, Forente stater, 90095
- University of California, Los Angeles
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Current treatment with antiretroviral medications
- Within the last sixty days, either (a) Self-reported risky alcohol use (defined as >14 drinks/week or >4 drinks/occasion for men 65 or younger; >7 drinks/week or >3 drinks/occasion for women); OR (b) >=two days of either cocaine or amphetamine use
- Able to provide voluntary informed consent as evidenced by ability to answer questions about the consent form
- Able and willing to use SimPill caps to store at least one antiretroviral medication
Exclusion Criteria:
- Physiological dependence on alcohol, illicit opioids or sedatives as assessed by the history and symptom review procedures
- Dispensed medications in a monitored setting
- Unable to speak English. The need for bilingual staff and cross-coverage to enroll monolingual Hispanic people is beyond this study's scope.
- Will not be able to complete the study because of anticipated incarceration or move
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: cognitive-behavioral therapy intervention
Reinforcement for medication-taking will be wired to debit cards that patients will be given to receive the payments.
This contingent reinforcement of medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT) conducted by phone, also assisted by the website which will generate CBT-related text messages, reminders and scheduling information from a menu of choices negotiated by the patient and therapist.
|
. Reinforcement for medication-taking will be wired to debit cards that patients will be given to receive the payments.
This contingent reinforcement of medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT) conducted by phone, also assisted by the website which will generate CBT-related text messages, reminders and scheduling information from a menu of choices negotiated by the patient and therapist.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
change of adherence to antiretroviral medications measured at weeks 0, 4, 8, 12, 16, 20, and 24
Tidsramme: weeks 0, 4, 8, 12, 16, 20, and 24.
|
collect information about adherence and behaviroal measures
|
weeks 0, 4, 8, 12, 16, 20, and 24.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
26. juli 2011
Først innsendt som oppfylte QC-kriteriene
3. august 2011
Først lagt ut (Anslag)
4. august 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
25. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- R34DA031643 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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