Centralized Off-Site Adherence Enhancement Program (CARE)

This study is not yet open for participant recruitment.
Verified July 2011 by University of California, Los Angeles
Sponsor:
Collaborators:
Yale University
Harbor Medical Inc.
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01409655
First received: July 26, 2011
Last updated: August 3, 2011
Last verified: July 2011

July 26, 2011
August 3, 2011
September 2011
April 2014   (final data collection date for primary outcome measure)
change of adherence to antiretroviral medications measured at weeks 0, 4, 8, 12, 16, 20, and 24 [ Time Frame: weeks 0, 4, 8, 12, 16, 20, and 24. ] [ Designated as safety issue: No ]
collect information about adherence and behaviroal measures
Same as current
Complete list of historical versions of study NCT01409655 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Centralized Off-Site Adherence Enhancement Program
Centralized Off-Site Adherence Enhancement Program

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV/AIDS
Behavioral: cognitive-behavioral therapy
. 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.
Other Name: CARE
Experimental: 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.
Intervention: Behavioral: cognitive-behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
August 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Honghu Liu, PHD 310-794-0700 hhliu@mednet.ucla.edu
United States
 
NCT01409655
R34DA031643
No
Honghu Liu/Professor, University of California, Los Angeles
University of California, Los Angeles
  • Yale University
  • Harbor Medical Inc.
Not Provided
University of California, Los Angeles
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP