ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01312181
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.

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 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors blind to randomization outcomes
Primary Purpose: Treatment
Official Title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
Actual Study Start Date : June 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

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

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). 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: HealthCall and 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). 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
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)
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
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
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.



Primary Outcome Measures :
  1. Frequency of Drug Use, Assessed at Baseline and at the End of Treatment so That Change Can be Analyzed. [ Time Frame: Assessed at end of treatment (60 days) ]
    One primary study outcome was frequency of drug use, represented by the total number of days of primary drug used in the prior 30 days (NumDU) as derived from the Time Line Follow Back (TLFB).

  2. Quantity of Drug Use, Assessed at Baseline and at the End of Treatment so That Change Can be Analyzed. [ Time Frame: Assessed at end of treatment (60 days) ]
    One primary study outcome was quantity of drug use in the prior 30 days, represented by the total dollar amount of primary drug used (QuantU) in the prior 30 days, as derived from the Time Line Follow Back (TLFB).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

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

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
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: May 2018

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
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs