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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
Enrollment 240
Recruitment Details 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 Of 533 individuals assessed, 240 patients were randomized to a treatment condition, and 224 were included in analyses of the results.
Arm/Group Title HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Hide Arm/Group Description

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.

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. 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.

Period Title: Overall Study
Started 80 77 83
Completed 78 71 75
Not Completed 2 6 8
Arm/Group Title HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control Total
Hide Arm/Group Description

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.

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. 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 of all reporting groups
Overall Number of Baseline Participants 80 77 83 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 77 participants 83 participants 240 participants
45.53  (9.23) 47.38  (8.31) 46.72  (10.32) 46.54  (9.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 77 participants 83 participants 240 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 77 participants 83 participants 240 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 77 participants 83 participants 240 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 77 participants 83 participants 240 participants
80 77 83 240
1.Primary Outcome
Title Total Number of Days of Primary Drug Used in the Prior 30 Days
Hide Description 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).
Time Frame Assessed at end of treatment (60 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Hide Arm/Group Description:

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.

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. 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.

Overall Number of Participants Analyzed 78 71 75
Mean (Standard Deviation)
Unit of Measure: Days
5.07  (6.7) 3.61  (5.79) 4.73  (7.22)
2.Primary Outcome
Title Total Dollar Value of Primary Drug Used in the Prior 30 Days
Hide Description 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).
Time Frame Assessed at end of treatment (60 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Hide Arm/Group Description:

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.

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. 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.

Overall Number of Participants Analyzed 78 71 75
Mean (Standard Deviation)
Unit of Measure: Dollars
6.70  (9.79) 6.47  (8.65) 6.56  (17.04)
Time Frame Serious and Other (Not Including Serious) Adverse Events were assessed throughout the data collection period (3 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Hide Arm/Group Description

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.

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. 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.

All-Cause Mortality
HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/71 (0.00%)   0/75 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/71 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HealthCall +Motivational Interviewing Motivational Interviewing (MI) HIV/AIDS Health Education - DVD Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/71 (0.00%)   0/75 (0.00%) 
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
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