Trial Outcomes & Findings for HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics (NCT NCT01312181)
NCT ID: NCT01312181
Last Updated: 2021-08-17
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Assessed at end of treatment (60 days)
Results posted on
2021-08-17
Participant Flow
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.
Of 533 individuals assessed, 240 patients were randomized to a treatment condition, and 224 were included in analyses of the results.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
77
|
83
|
|
Overall Study
COMPLETED
|
78
|
71
|
75
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
Baseline characteristics by cohort
| Measure |
HealthCall +Motivational Interviewing
n=80 Participants
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)
n=77 Participants
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
n=83 Participants
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
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.53 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
47.38 years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
46.72 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
46.54 years
STANDARD_DEVIATION 9.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
77 participants
n=7 Participants
|
83 participants
n=5 Participants
|
240 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
HealthCall +Motivational Interviewing
n=78 Participants
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)
n=71 Participants
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
n=75 Participants
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 Number of Days of Primary Drug Used in the Prior 30 Days
|
5.07 Days
Standard Deviation 6.7
|
3.61 Days
Standard Deviation 5.79
|
4.73 Days
Standard Deviation 7.22
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
HealthCall +Motivational Interviewing
n=78 Participants
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)
n=71 Participants
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
n=75 Participants
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 Dollar Value of Primary Drug Used in the Prior 30 Days
|
6.70 Dollars
Standard Deviation 9.79
|
6.47 Dollars
Standard Deviation 8.65
|
6.56 Dollars
Standard Deviation 17.04
|
Adverse Events
HealthCall +Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interviewing (MI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV/AIDS Health Education - DVD Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place