Drug Abuse, HIV Risk Behavior
Conditions
Keywords
SBIRT, Drug abuse
Brief summary
The purpose of this study is to compare the effectiveness in reducing drug use and its associated problems of a brief intervention for drug use delivered by a behavioral health counselor as compared to a brief intervention delivered by a computerized intervention.
Detailed description
Drug use is a significant cause of morbidity and mortality in the United States. Efforts to develop and rigorously evaluate methods to provide Screening, Brief Intervention and Referral to Treatment (SBIRT) for drug users are needed. Computerized screening and brief interventions in particular have the potential to circumvent some of the potential problems of integrating SBIRT delivered by a counselor into busy primary care settings. These interventions may reduce drug use among individuals who are using drugs but are not yet drug dependent.
Interventions
BEHAVIORALComputerized brief intervention
This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.
BEHAVIORALCounselor delivered brief intervention
This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.
Sponsors
National Institute on Drug Abuse (NIDA)
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Moderate risk category on the ASSIST scores
Exclusion criteria
* planning to move out of New Mexico in the next year * receipt of formal drug abuse treatment or a brief intervention for drug use in the past month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 3 months post-baseline | The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308. |
| Hair Testing | 3 month post-baseline | The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score | 12 month post-baseline | HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. |
| Hair Testing | 6 month post-baseline | The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations. |
| Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 6 month post-baseline | ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk. |
| Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale | 3 months post-baseline | HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. |
| Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale | 6 month post-baseline | HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Computerized Brief Intervention Computerized one-session brief intervention for drug use
Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session. | 180 |
| Counselor Delivered Brief Intervention This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing
Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing. | 179 |
| Total | 359 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Computer problem | 1 | 0 |
| Overall Study | Counselor not available | 0 | 3 |
| Overall Study | Subject changed history after enrollment | 0 | 1 |
Baseline characteristics
| Characteristic | Counselor Delivered Brief Intervention | Total | Computerized Brief Intervention |
|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 14.6 | 36.1 years STANDARD_DEVIATION 14.6 | 36.5 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 85 Participants | 168 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 191 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 161 Participants | 323 Participants | 162 Participants |
| Region of Enrollment United States | 179 Participants | 359 Participants | 180 Participants |
| Sex: Female, Male Female | 82 Participants | 165 Participants | 83 Participants |
| Sex: Female, Male Male | 97 Participants | 194 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 180 | 0 / 179 |
| serious Total, serious adverse events | 0 / 180 | 0 / 179 |
Outcome results
Primary
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308.
Time frame: 3 months post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 27.8 units on a scale | Standard Error 0.93 |
| Counselor Delivered Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 29.6 units on a scale | Standard Error 0.93 |
Primary
Hair Testing
The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)
Time frame: 3 month post-baseline
Population: The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Computerized Brief Intervention | Hair Testing | 93 Participants |
| Counselor Delivered Brief Intervention | Hair Testing | 100 Participants |
Secondary
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time frame: 6 month post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 27.3 units on a scale | Standard Error 1.3 |
| Counselor Delivered Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 27.4 units on a scale | Standard Error 1.33 |
Secondary
Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time frame: 12 months post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 26.5 units on a scale | Standard Error 1.32 |
| Counselor Delivered Brief Intervention | Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score | 25.9 units on a scale | Standard Error 1.34 |
Secondary
Hair Testing
Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
Time frame: 12 month post-baseline
Population: The sample includes participants who provided usable hair testing data at baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Hair Testing | .57 predicted probability of positive test | Standard Error 0.04 |
| Counselor Delivered Brief Intervention | Hair Testing | .59 predicted probability of positive test | Standard Error 0.04 |
Secondary
Hair Testing
The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.
Time frame: 6 month post-baseline
Population: The sample includes participants who provided usable hair testing data at baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Hair Testing | .59 predicted probability of positive test | Standard Error 0.04 |
| Counselor Delivered Brief Intervention | Hair Testing | .67 predicted probability of positive test | Standard Error 0.04 |
Secondary
Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time frame: 3 months post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale | .06 units on a scale | Standard Error 0.03 |
| Counselor Delivered Brief Intervention | Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale | .01 units on a scale | Standard Error 0.03 |
Secondary
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time frame: 6 month post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale | .02 units on a scale | Standard Error 0.03 |
| Counselor Delivered Brief Intervention | Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale | .04 units on a scale | Standard Error 0.03 |
Secondary
Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time frame: 12 month post-baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Computerized Brief Intervention | Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score | .05 units on a scale | Standard Error 0.03 |
| Counselor Delivered Brief Intervention | Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score | .01 units on a scale | Standard Error 0.04 |