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

NCT02294318 | Completed Results DMC

• 1 other identifier: DA024606-S
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol or Other Drugs Use

Outcome Measures

Primary Outcomes (4)

• Mean Number of Days Used Primary Drug (NumDU)

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

  60 days

• Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)

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

  60 days

• Mean Number of Drinking Days (NumDD)

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

  60 days

• Mean Number of Drinks Per Day (QuantDD)

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

  60 days

Study Arms (2)

Motivational Interviewing (MI)

ACTIVE COMPARATOR

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

HealthCall+Motivational Interviewing

EXPERIMENTAL

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

Interventions

HealthCall+Motivational Interviewing BEHAVIORAL

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.

Also known as: MI+HealthCall

HealthCall+Motivational Interviewing

Motivational Interviewing BEHAVIORAL

Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.

Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (1)

The New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 23432593 BACKGROUND

• 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.

  PMID: 22428809 BACKGROUND

• Aharonovich E, Stohl M, Cannizzaro D, Hasin D. HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. J Subst Abuse Treat. 2017 Dec;83:15-26. doi: 10.1016/j.jsat.2017.09.013. Epub 2017 Sep 29.

  PMID: 29129192 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and 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.

Results Point of Contact

• Title: Dr. Efrat Aharonovich
• Organization: ResearchFMH

efrat.aharonovich@nyspi.columbia.edu

646-774-7954

Study Officials

• Efrat Aharonovich, PhD

  The New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist V

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 19, 2014
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 17, 2021
• Results First Posted: June 3, 2019

Record last verified: 2021-08

Locations

US (1)