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HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics

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ClinicalTrials.gov Identifier: NCT01312181
Recruitment Status : Unknown
Verified November 2015 by Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2011
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality. Thus reducing NIDU among HIV infected individuals is critical to their survival and to limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands little from busy medical staff and is well accepted by patients. In a 3-arm randomized clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b) MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.

Condition or disease Intervention/treatment Phase
Mental and Behavioral Disorders Due to Multiple Drug Use and Use of Other Psychoactive Substances: Harmful Use Behavioral: HealthCall and Motivational Interviewing Behavioral: Motivational Interviewing (MI) Behavioral: HIV/AIDS health education Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
Study Start Date : June 2011
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: HealthCall +Motivational Interviewing
Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc).
 Behavioral: HealthCall and Motivational Interviewing
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.
Active Comparator: Motivational Interviewing (MI)
The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk
 Behavioral: Motivational Interviewing (MI)
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.
Placebo Comparator: HIV/AIDS health education - DVD control
HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.
 Behavioral: HIV/AIDS health education
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome variable is drug use, assessed at baseline and repeatedly during follow-up so that change can be analyzed. [ Time Frame: Assessed at baseline, 30 and 60 days, 3,6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All research volunteers will be 18 and older and HIV positive. We will include participants whose primary drug is non-injection use of cocaine, opioids including heroin, or methamphetamines and current use in the past 30 days > 4 days. Participants will need to complete a medically supervised detoxification if such detoxification is required.

Exclusion Criteria:

  • Excluded are research volunteers for whom participation would not be clinically appropriate, who clearly could not participate. Psychotic, suicidal or homicidal patients require clinical management that is too intensive for this study, and we have no evidence that MI+HealthCall would be effective among injection drug users. Leaving New York precludes follow-up. Gross psychomotor/cognitive impairments that may hinder patients' HealthCall use. Hearing and severe vision impairments that preclude telephone use precludes randomization to MI+HealthCall.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312181


Locations
United States, New York
Mt Sinai Spencer Cox Center for Health
New York, New York, United States, 10019
Institute for Advanced Medicine, Mt. Sinai services
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Efrat Aharonovich, PhD The New York State Psychiatric Institute and Columbia Univeristy
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Efrat Aharonovich, Resarch Scientist, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01312181     History of Changes
Other Study ID Numbers: R01DA024606 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.:
Technology based intervention
HIV primary care clinic
Brief behavioral intervention
Drug abuse

Additional relevant MeSH terms:
Problem Behavior
Behavioral Symptoms