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

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

Detailed Description
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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.

Official Title
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HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care

Conditions
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Alcohol or Other Drugs Use

Intervention / Treatment
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* Behavioral: HealthCall+Motivational Interviewing
* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Interviewing (MI)<br>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<br>* Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.<br>|
| Experimental: HealthCall+Motivational Interviewing<br>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<br>* 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.<br>* Other names: MI+HealthCall;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |