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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.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Mental and Behavioral Disorders Due to Multiple Drug Use and Use of Other Psychoactive Substances: Harmful Use
Interventions: Behavioral: HealthCall and Motivational Interviewing
Behavioral: Motivational Interviewing (MI)
Behavioral: HIV/AIDS health education

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants age > 18 with > 4 days of NIDU during the prior 30 days were recruited from large urban HIV primary care clinics between 2011 and 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 533 individuals assessed, 240 patients were randomized to a treatment condition, and 224 were included in analyses of the results.

Reporting Groups
  Description
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).

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.

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

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.

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.

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.


Participant Flow:   Overall Study
    HealthCall +Motivational Interviewing   Motivational Interviewing (MI)   HIV/AIDS Health Education - DVD Control
STARTED   80   77   83 
COMPLETED   78   71   75 
NOT COMPLETED   2   6   8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

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.

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

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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   HealthCall +Motivational Interviewing   Motivational Interviewing (MI)   HIV/AIDS Health Education - DVD Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   77   83   240 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.53  (9.23)   47.38  (8.31)   46.72  (10.32)   46.54  (9.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      14  17.5%      10  13.0%      15  18.1%      39  16.3% 
Male      66  82.5%      67  87.0%      68  81.9%      201  83.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      22  27.5%      23  29.9%      17  20.5%      62  25.8% 
Not Hispanic or Latino      58  72.5%      54  70.1%      66  79.5%      178  74.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      48  60.0%      39  50.6%      45  54.2%      132  55.0% 
White      32  40.0%      38  49.4%      38  45.8%      108  45.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   80   77   83   240 


  Outcome Measures

1.  Primary:   Total Number of Days of Primary Drug Used in the Prior 30 Days   [ Time Frame: Assessed at end of treatment (60 days) ]

2.  Primary:   Total Dollar Value of Primary Drug Used in the Prior 30 Days   [ Time Frame: Assessed at end of treatment (60 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Efrat Aharonovich
Organization: ResearchFMH
phone: 646-774-7954
e-mail: efrat.aharonovich@nyspi.columbia.edu


Publications:

Responsible Party: Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01312181     History of Changes
Other Study ID Numbers: R01DA024606 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2011
First Posted: March 10, 2011
Results First Submitted: April 10, 2018
Results First Posted: May 15, 2018
Last Update Posted: June 14, 2018