NCT01312181

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 15, 2018

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

March 9, 2011

Results QC Date

April 10, 2018

Last Update Submit

August 15, 2021

Conditions

Mental and Behavioral Disorders Due to Harmful Drug Use

Keywords

Technology based interventionHIV primary care clinicBrief behavioral interventionDrug abuse

Outcome Measures

Primary Outcomes (2)

  • Total Number of Days of Primary Drug Used in the Prior 30 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).

    Assessed at end of treatment (60 days)

  • Total Dollar Value of Primary Drug Used in the Prior 30 Days

    One primary study outcome was quantity of drug used 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).

    Assessed at end of treatment (60 days)

Study Arms (3)

HealthCall +Motivational Interviewing

ACTIVE COMPARATOR

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

Motivational Interviewing (MI)

ACTIVE COMPARATOR

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)

HIV/AIDS health education - DVD control

PLACEBO COMPARATOR

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

Interventions

HealthCall and Motivational InterviewingBEHAVIORAL

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

HealthCall +Motivational Interviewing
Motivational Interviewing (MI)BEHAVIORAL

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

Motivational Interviewing (MI)
HIV/AIDS health educationBEHAVIORAL

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.

HIV/AIDS health education - DVD control

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mt Sinai Spencer Cox Center for Health

New York, New York, 10019, United States

Location

Institute for Advanced Medicine, Mt. Sinai services

New York, New York, 10032, United States

Location

Related Publications (2)

  • Aharonovich E, Greenstein E, O'Leary A, Johnston B, Seol SG, Hasin DS. HealthCall: technology-based extension of motivational interviewing to reduce non-injection drug use in HIV primary care patients - a pilot study. AIDS Care. 2012;24(12):1461-9. doi: 10.1080/09540121.2012.663882. Epub 2012 Mar 20.

    PMID: 22428809BACKGROUND

  • Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.

    PMID: 23432593BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Efrat Aharonovich
Organization
ResearchFMH
efrat.aharonovich@nyspi.columbia.edu
646-774-7954

Study Officials

  • Efrat Aharonovich, PhD

    The New York State Psychiatric Institute and Columbia Univeristy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors blind to randomization outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resarch Scientist

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 10, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

August 17, 2021

Results First Posted

May 15, 2018

Record last verified: 2021-08

Locations

US(2)