Trial Outcomes & Findings for HealthCall-S: A Pilot Study Targeting Concurrent Non-injection Drug Use and Alcohol in HIV Primary Care Clinics (NCT NCT02294318)

NCT ID: NCT02294318

Last Updated: 2021-08-17

Results Overview

This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2021-08-17

Participant Flow

Participant milestones

Measure	Motivational Interviewing (MI) Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Overall Study STARTED	24	23
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Motivational Interviewing (MI) Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Overall Study Worsening of drinking	3	0
Overall Study Not exposed to intervention	0	2

Baseline Characteristics

HealthCall-S: A Pilot Study Targeting Concurrent Non-injection Drug Use and Alcohol in HIV Primary Care Clinics

Baseline characteristics by cohort

Measure	Motivational Interviewing (MI) n=24 Participants Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 Participants The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.	Total n=47 Participants Total of all reporting groups
Age, Continuous	50.92 years STANDARD_DEVIATION 7.21 • n=5 Participants	51 years STANDARD_DEVIATION 7.02 • n=7 Participants	50.96 years STANDARD_DEVIATION 7.04 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

Outcome measures

Measure	Motivational Interviewing (MI) n=21 Participants Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 Participants The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Mean Number of Days Used Primary Drug (NumDU)	8.5 days Standard Deviation 6.1	5.0 days Standard Deviation 5.7

PRIMARY outcome

Timeframe: 60 days

This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

Outcome measures

Measure	Motivational Interviewing (MI) n=21 Participants Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 Participants The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)	14.6 dollars Standard Deviation 12.7	7.1 dollars Standard Deviation 9.0

PRIMARY outcome

Timeframe: 60 days

This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

Outcome measures

Measure	Motivational Interviewing (MI) n=21 Participants Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 Participants The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Mean Number of Drinking Days (NumDD)	8.1 days Standard Deviation 5.7	7.0 days Standard Deviation 7.6

PRIMARY outcome

Timeframe: 60 days

This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

Outcome measures

Measure	Motivational Interviewing (MI) n=21 Participants Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 Participants The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Mean Number of Drinks Per Day (QuantDD)	1.3 standard drinks Standard Deviation 1.1	.9 standard drinks Standard Deviation 1

Adverse Events

Motivational Interviewing (MI)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

HealthCall+Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Motivational Interviewing (MI) n=24 participants at risk Participants will engage in a 30-minute Motivational Interviewing session with the study counselor to discuss participant's drug and alcohol use, its implications for their health, and the possibility of drug and alcohol use reduction. This counseling session is intended to help people reduce their drug and alcohol use if they wish. In the counseling session, participants describe the pros and cons of their drug and alcohol use and whether it might be important to quit using drugs and drinking alcohol. Open discussion of the pros (what they like about drug use and drinking) and cons (what they don't like) can help people think about reducing drug and alcohol use in a more complete way than they might have before. This arm will be compared to the HealthCall+Motivational Interviewing arm. Motivational Interviewing: Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.	HealthCall+Motivational Interviewing n=23 participants at risk The HealthCall+Motivational Interviewing arm will investigate whether the addition of HealthCall, a smartphone application designed to keep track of the participant's drug and alcohol use and other health-related behaviors through short daily use, will help participants reduce their substance use more than Motivational Interviewing alone. Participants will receive the same 30-minute Motivational Interviewing session as described in the MI arm. After the session, participants will be introduced to HealthCall and will be asked to use the app daily over the next 30 days. Each use lasts 2-3 minutes and can be done anywhere on the phone in the U.S. The purpose of daily HealthCall use is to help participants keep track of their drug and alcohol use. HealthCall+Motivational Interviewing (MI): HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
Psychiatric disorders worsening of alcohol use	12.5% 3/24 • Number of events 3 • through study completion, an average of 60 days	0.00% 0/23 • through study completion, an average of 60 days

Other adverse events

Adverse event data not reported

Additional Information

Dr. Efrat Aharonovich

ResearchFMH

Phone: 646-774-7954

Email: efrat.aharonovich@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place