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
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Condition or disease | Intervention/treatment | Phase |
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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 (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 |

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).
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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.
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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
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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.
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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.
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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.
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- 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 ]

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

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
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 |
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 |
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 |