NCT01409655

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

July 26, 2011

Last Update Submit

February 23, 2016

Conditions

HIV/AIDS, Medication Adherence

Keywords

AIDS, HIV, Adherence, Compliance, Contingency management

Outcome Measures

Primary Outcomes (1)

  • change of adherence to antiretroviral medications measured at 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.

Study Arms (1)

cognitive-behavioral therapy intervention

EXPERIMENTAL

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.

Behavioral: cognitive-behavioral therapy

Interventions

cognitive-behavioral therapyBEHAVIORAL

. 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.

Also known as: CARE
cognitive-behavioral therapy intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication AdherencePatient Compliance

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 4, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

US(1)