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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Research Foundation for Mental Hygiene, Inc.
Sponsor:
Information provided by (Responsible Party):
Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01312181
First received: March 9, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All research volunteers will be 18 and older. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312181

Contacts
Contact: Efrat Aharonovich, PhD ea2017@columbia.edu

Locations
United States, New York
HIV Primary Care Clinic, Mount Sinai Hospital Active, not recruiting
New York, New York, United States, 10032
Mt Sinai Spencer Cox Center for Health Recruiting
New York, New York, United States, 10019
Contact: Hannah Wolfe, PhD    212-865-9213    HWolfe@chpnet.org   
Principal Investigator: Hannah Wolfe, PhD         
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

Publications:
Responsible Party: Efrat Aharonovich, Resarch Scientist, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01312181     History of Changes
Other Study ID Numbers: R01 DA024606-01
Study First Received: March 9, 2011
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014