Clinical trial NCT01312181: HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
Official title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental and Behavioral Disorders Due to Harmful Drug Use
Keywords: Technology based intervention
HIV primary care clinic
Brief behavioral intervention
Drug abuse
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Total Number of Days of Primary Drug Used in the Prior 30 Days
timeFrame: Assessed at end of treatment (60 days)
measure: Total Dollar Value of Primary Drug Used in the Prior 30 Days
timeFrame: Assessed at end of treatment (60 days)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt Sinai Spencer Cox Center for Health
state: New York
city: New York
country: United States
facility: Institute for Advanced Medicine, Mt. Sinai services
state: New York
Study officials:
affiliation: The New York State Psychiatric Institute and Columbia Univeristy
name: Efrat Aharonovich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.