Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02294318
Enrollment
47
Registered
2014-11-19
Start date
2015-06-30
Completion date
2016-03-31
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol or Other Drugs Use

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.

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.

Interventions

BEHAVIORALHealthCall+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.

BEHAVIORALMotivational Interviewing

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

Sponsors

Research Foundation for Mental Hygiene, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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. \-

Design outcomes

Primary

MeasureTime frameDescription
Mean Number of Days Used Primary Drug (NumDU)60 daysThis 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)60 daysThis outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).
Mean Number of Drinking Days (NumDD)60 daysThis 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)60 daysThis outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
24
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.
23
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNot exposed to intervention02
Overall StudyWorsening of drinking30

Baseline characteristics

CharacteristicMotivational Interviewing (MI)TotalHealthCall+Motivational Interviewing
Age, Continuous50.92 years
STANDARD_DEVIATION 7.21
50.96 years
STANDARD_DEVIATION 7.04
51 years
STANDARD_DEVIATION 7.02
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants8 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants39 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
19 Participants37 Participants18 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants10 Participants5 Participants
Region of Enrollment
United States
24 Participants47 Participants23 Participants
Sex: Female, Male
Female
5 Participants11 Participants6 Participants
Sex: Female, Male
Male
19 Participants36 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 23
other
Total, other adverse events
0 / 240 / 23
serious
Total, serious adverse events
3 / 240 / 23

Outcome results

Primary

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).

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)14.6 dollarsStandard Deviation 12.7
HealthCall+Motivational InterviewingMean Dollar Amount Spent Per Day on Primary Drug (QuantU)7.1 dollarsStandard Deviation 9
Primary

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).

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Mean Number of Days Used Primary Drug (NumDU)8.5 daysStandard Deviation 6.1
HealthCall+Motivational InterviewingMean Number of Days Used Primary Drug (NumDU)5.0 daysStandard Deviation 5.7
Primary

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).

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Mean Number of Drinking Days (NumDD)8.1 daysStandard Deviation 5.7
HealthCall+Motivational InterviewingMean Number of Drinking Days (NumDD)7.0 daysStandard Deviation 7.6
Primary

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).

Time frame: 60 days

ArmMeasureValue (MEAN)Dispersion
Motivational Interviewing (MI)Mean Number of Drinks Per Day (QuantDD)1.3 standard drinksStandard Deviation 1.1
HealthCall+Motivational InterviewingMean Number of Drinks Per Day (QuantDD).9 standard drinksStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026