HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
Sponsor
Research Foundation for Mental Hygiene, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT01312181
Collaborator
(none)
240
2
3
62
120
1.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessors blind to randomization outcomes
Primary Purpose:
Treatment
Official Title:
HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
Actual Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Aug 1, 2015
Actual Study Completion Date
:
Aug 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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
|
| 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 |
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
|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Total Number of Days of Primary Drug Used in the Prior 30 Days [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 [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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mt Sinai Spencer Cox Center for Health | New York | New York | United States | 10019 |
| 2 | Institute for Advanced Medicine, Mt. Sinai services | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Research Foundation for Mental Hygiene, Inc.
Investigators
- Principal Investigator: Efrat Aharonovich, PhD, The New York State Psychiatric Institute and Columbia Univeristy
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Efrat Aharonovich,
Resarch Scientist,
Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01312181
Other Study ID Numbers:
- R01DA024606
First Posted:
Mar 10, 2011
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Efrat Aharonovich,
Resarch Scientist,
Research Foundation for Mental Hygiene, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control | Total |
|---|---|---|---|---|
| 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 Participants | 80 | 77 | 83 | 240 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
45.53
(9.23)
|
47.38
(8.31)
|
46.72
(10.32)
|
46.54
(9.34)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
14
17.5%
|
10
13%
|
15
18.1%
|
39
16.3%
|
| Male |
66
82.5%
|
67
87%
|
68
81.9%
|
201
83.8%
|
| Ethnicity (NIH/OMB) (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%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
48
60%
|
39
50.6%
|
45
54.2%
|
132
55%
|
| White |
32
40%
|
38
49.4%
|
38
45.8%
|
108
45%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
80
100%
|
77
100%
|
83
100%
|
240
100%
|
Outcome Measures
| Title | Total Number of Days of Primary Drug Used in the Prior 30 Days |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control |
|---|---|---|---|
| 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. |
| Measure Participants | 78 | 71 | 75 |
| Mean (Standard Deviation) [Days] |
5.07
(6.7)
|
3.61
(5.79)
|
4.73
(7.22)
|
| Title | Total Dollar Value of Primary Drug Used in the Prior 30 Days |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control |
|---|---|---|---|
| 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. |
| Measure Participants | 78 | 71 | 75 |
| Mean (Standard Deviation) [Dollars] |
6.70
(9.79)
|
6.47
(8.65)
|
6.56
(17.04)
|
Adverse Events
| Time Frame | Serious and Other (Not Including Serious) Adverse Events were assessed throughout the data collection period (3 years). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/78 (0%) | 0/71 (0%) | 0/75 (0%) | |||
Serious Adverse Events |
||||||
| HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/78 (0%) | 0/71 (0%) | 0/75 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/78 (0%) | 0/71 (0%) | 0/75 (0%) | |||
Limitations/Caveats
[Not Specified]
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 |
| efrat.aharonovich@nyspi.columbia.edu |
Responsible Party:
Efrat Aharonovich,
Resarch Scientist,
Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01312181
Other Study ID Numbers:
- R01DA024606
First Posted:
Mar 10, 2011
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021