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

• Sponsor: Research Foundation for Mental Hygiene, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02294318
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

This pilot study goal is to compare two different treatments to help HIV positive patients reduce their concurrent drinking and non-injection drug use.

Condition or Disease	Intervention/Treatment	Phase
Alcohol or Other Drugs Use	Behavioral: HealthCall+Motivational Interviewing; Behavioral: Motivational Interviewing	N/A

Detailed Description

The goal of this study is to compare the effects of brief motivational interviewing with participation in HealthCall to brief motivational interviewing alone on non-injection drug and alcohol use. HealthCall involves 2-3 minutes of daily smartphone use to track drug use, drinking behaviors and other aspects of health, followed by personalized feedback in a graph after 30 and 60 days of using the smartphone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Motivational Interviewing; Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.
Experimental: 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.	Behavioral: HealthCall+Motivational Interviewing; 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.; Other Names: MI+HealthCall

Outcome Measures

Primary Outcome Measures

1. Mean Number of Days Used Primary Drug (NumDU) [60 days]

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

2. Mean Dollar Amount Spent Per Day on Primary Drug (QuantU) [60 days]

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

3. Mean Number of Drinking Days (NumDD) [60 days]

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

4. Mean Number of Drinks Per Day (QuantDD) [60 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Age 18 and older; 2. During the prior 30 days, > 4 days of non-injection of cocaine, methamphetamine or heroin, one of which is identified by the patient as his/her primary drug During prior 30 days, > 1 day of binge drinking (>4 drinks on one occasion); Completion of medically supervised detoxification if such detoxification is required; HIV Positive ; Able to give informed consent

Exclusion Criteria:

Patient is currently psychotic, suicidal, or homicidal. Patient has injected any drug in the last 6 months Patient has definite plans to leave the greater New York metropolitan area within the study period.

Patient has gross cognitive/psychomotor impairment as evidenced on the Halstead-Reitan Trails (A+B) Patient does not speak English or Spanish Patient has a hearing and/or vision impairment that precludes smartphone use.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The New York State Psychiatric Institute	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

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, Research Scientist V, Research Foundation for Mental Hygiene, Inc.
• ClinicalTrials.gov Identifier: NCT02294318
• Other Study ID Numbers: DA024606-S
• First Posted: Nov 19, 2014
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

Study Results

Participant Flow

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	24	23
COMPLETED	21	21
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	24	23	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.92 (7.21)	51 (7.02)	50.96 (7.04)
Sex: Female, Male (Count of Participants)
Female	5 20.8%	6 26.1%	11 23.4%
Male	19 79.2%	17 73.9%	36 76.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 12.5%	5 21.7%	8 17%
Not Hispanic or Latino	21 87.5%	18 78.3%	39 83%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	19 79.2%	18 78.3%	37 78.7%
White	5 20.8%	5 21.7%	10 21.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	24 100%	23 100%	47 100%

Outcome Measures

1. Primary Outcome

Title	Mean Number of Days Used Primary Drug (NumDU)
Description	This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing
Arm/Group Description	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.	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.
Measure Participants	21	23
Mean (Standard Deviation) [days]	8.5 (6.1)	5.0 (5.7)

2. Primary Outcome

Title	Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)
Description	This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing
Arm/Group Description	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.	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.
Measure Participants	21	23
Mean (Standard Deviation) [dollars]	14.6 (12.7)	7.1 (9.0)

3. Primary Outcome

Title	Mean Number of Drinking Days (NumDD)
Description	This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing
Arm/Group Description	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.	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.
Measure Participants	21	23
Mean (Standard Deviation) [days]	8.1 (5.7)	7.0 (7.6)

4. Primary Outcome

Title	Mean Number of Drinks Per Day (QuantDD)
Description	This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interviewing (MI)	HealthCall+Motivational Interviewing
Arm/Group Description	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.	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.
Measure Participants	21	23
Mean (Standard Deviation) [standard drinks]	1.3 (1.1)	.9 (1)

Adverse Events

Time Frame	through study completion, an average of 60 days
Arm/Group Title	Motivational Interviewing (MI)		HealthCall+Motivational Interviewing
Arm/Group Description	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.		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.
All Cause Mortality
	Motivational Interviewing (MI)		HealthCall+Motivational Interviewing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)
Serious Adverse Events
	Motivational Interviewing (MI)		HealthCall+Motivational Interviewing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/24 (12.5%)		0/23 (0%)
Psychiatric disorders
worsening of alcohol use	3/24 (12.5%)	3	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	Motivational Interviewing (MI)		HealthCall+Motivational Interviewing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)

Limitations/Caveats

Recruitment limited to an outpatient clinic in urban setting only. Study does not provide information about patients presenting with severe withdrawal who might benefit from HealthCall once condition is resolved.

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.