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

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ClinicalTrials.gov Identifier: NCT01312181
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : May 15, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.

March 9, 2011
March 10, 2011
April 10, 2018
May 15, 2018
June 14, 2018
June 2011
August 2015   (Final data collection date for primary outcome measure)
  • Total Number of Days of Primary Drug Used in the Prior 30 Days [ 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).
  • Total Dollar Value of Primary Drug Used in the Prior 30 Days [ Time Frame: Assessed at end of treatment (60 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).
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 ]
Complete list of historical versions of study NCT01312181 on ClinicalTrials.gov Archive Site
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HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Assessors blind to randomization outcomes
Primary Purpose: Treatment
Mental and Behavioral Disorders Due to Multiple Drug Use and Use of Other Psychoactive Substances: Harmful Use
  • 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
  • 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
  • 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.
  • 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
    Intervention: Behavioral: HealthCall and Motivational Interviewing
  • 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
    Intervention: Behavioral: Motivational Interviewing (MI)
  • 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.
    Intervention: Behavioral: HIV/AIDS health education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
390
August 2016
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01312181
R01DA024606( U.S. NIH Grant/Contract )
Yes
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Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
Research Foundation for Mental Hygiene, Inc.
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Principal Investigator: Efrat Aharonovich, PhD The New York State Psychiatric Institute and Columbia Univeristy
Research Foundation for Mental Hygiene, Inc.
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP