Mental and Behavioral Disorders Due to Harmful Drug Use
Conditions
Keywords
Technology based intervention, HIV primary care clinic, Brief behavioral intervention, Drug abuse
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.
Interventions
BEHAVIORALHealthCall 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
BEHAVIORALMotivational 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
BEHAVIORALHIV/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.
Sponsors
Research Foundation for Mental Hygiene, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors blind to randomization outcomes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
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 details
Of 533 individuals assessed, 240 patients were randomized to a treatment condition, and 224 were included in analyses of the results.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 77 |
| 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. | 83 |
| Total | 240 |
Baseline characteristics
| Characteristic | Total | HealthCall +Motivational Interviewing | Motivational Interviewing (MI) | HIV/AIDS Health Education - DVD Control |
|---|---|---|---|---|
| Age, Continuous | 46.54 years STANDARD_DEVIATION 9.34 | 45.53 years STANDARD_DEVIATION 9.23 | 47.38 years STANDARD_DEVIATION 8.31 | 46.72 years STANDARD_DEVIATION 10.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 22 Participants | 23 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 178 Participants | 58 Participants | 54 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants | 48 Participants | 39 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 108 Participants | 32 Participants | 38 Participants | 38 Participants |
| Region of Enrollment United States | 240 participants | 80 participants | 77 participants | 83 participants |
| Sex: Female, Male Female | 39 Participants | 14 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 201 Participants | 66 Participants | 67 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 71 | 0 / 75 |
| other Total, other adverse events | 0 / 78 | 0 / 71 | 0 / 75 |
| serious Total, serious adverse events | 0 / 78 | 0 / 71 | 0 / 75 |
Outcome results
Primary
Total Dollar Value of Primary Drug Used in the Prior 30 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).
Time frame: Assessed at end of treatment (60 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthCall +Motivational Interviewing | Total Dollar Value of Primary Drug Used in the Prior 30 Days | 6.70 Dollars | Standard Deviation 9.79 |
| Motivational Interviewing (MI) | Total Dollar Value of Primary Drug Used in the Prior 30 Days | 6.47 Dollars | Standard Deviation 8.65 |
| HIV/AIDS Health Education - DVD Control | Total Dollar Value of Primary Drug Used in the Prior 30 Days | 6.56 Dollars | Standard Deviation 17.04 |
Primary
Total Number of Days of Primary Drug Used in the Prior 30 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).
Time frame: Assessed at end of treatment (60 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthCall +Motivational Interviewing | Total Number of Days of Primary Drug Used in the Prior 30 Days | 5.07 Days | Standard Deviation 6.7 |
| Motivational Interviewing (MI) | Total Number of Days of Primary Drug Used in the Prior 30 Days | 3.61 Days | Standard Deviation 5.79 |
| HIV/AIDS Health Education - DVD Control | Total Number of Days of Primary Drug Used in the Prior 30 Days | 4.73 Days | Standard Deviation 7.22 |