Alcohol or Other Drugs UseNCT02294318
HealthCall-S: A Pilot Study Targeting Concurrent Non-injection Drug Use and Alcohol in HIV Primary Care Clinics
A study testing HealthCall+Motivational Interviewing and Motivational Interviewing in people with Alcohol or Other Drugs Use, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol or Other Drugs Use
- What is being tested?
- HealthCall+Motivational Interviewing and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
This pilot study goal is to compare two different treatments to help HIV positive patients reduce their concurrent drinking and non-injection drug use.
Read the 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.
- Conditions
- Alcohol or Other Drugs Use
- Being tested
- HealthCall+Motivational Interviewing, Motivational Interviewing
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthCall+Motivational InterviewingBehavioural
Also called MI+HealthCall
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.
Motivational InterviewingBehavioural
Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: HealthCall+Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol or Other Drugs UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Efrat Aharonovich, PhD, Principal investigator, The New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294318
- Sponsor's protocol ID
- DA024606-S
- Status last verified
- Aug 2021
- First submitted
- 17 Nov 2014
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23432593Aharonovich 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.
PubMed 22428809Aharonovich 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.
PubMed 29129192
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
- ClinicalTrials.gov ID
- NCT02294318
- Acronym / sponsor ID
- DA024606-S
- Conditions
- Alcohol or Other Drugs Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Active comparator | Behavioral: Motivational InterviewingParticipants 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. |
| HealthCall+Motivational Interviewing | Experimental | Behavioral: HealthCall+Motivational InterviewingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthCall+Motivational InterviewingAlso: MI+HealthCallHealthCall 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. | Behavioural | HealthCall+Motivational Interviewing |
| Motivational InterviewingMotivational Interviewing is a client-centered counseling approach for eliciting behavior change. | Behavioural | Motivational Interviewing (MI) |
Primary outcome
Mean Number of Days Used Primary Drug (NumDU)
Time frame: 60 days
This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)
Time frame: 60 days
This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Mean Number of Drinking Days (NumDD)
Time frame: 60 days
This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Mean Number of Drinks Per Day (QuantDD)
Time frame: 60 days
This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23432593Hasin 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.
- Background: PubMed 22428809Aharonovich 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.
- Results publication: PubMed 29129192Aharonovich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efrat Aharonovich, PhD principal investigator
The New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthCall+Motivational Interviewing and Motivational Interviewing in people with Alcohol or Other Drugs Use, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Days Used Primary Drug (NumDU) (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294318, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.