HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Among HIV-infected individuals, non-injection drug use (NIDU) is associated with poor HIV medication adherence, greater HIV/AIDS risk behaviors, and increasing non-AIDS mortality. Thus reducing NIDU among HIV infected individuals is critical to their survival and to limiting the spread of HIV. We propose to study the efficacy of a technologically enhanced brief intervention (HealthCall) to reduce NIDU in HIV primary care patients that demands little from busy medical staff and is well accepted by patients. In a 3-arm randomized clinical trial will test the efficacy of (a) Motivational Interviewing (MI)+HealthCall; (b) MI-only; and (c) a control condition (advice + DVD HIV health education) in reducing NIDU.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02294318

Alcohol or Other Drugs Use

COMPLETED NA

Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

NCT04280068

Alcohol Dependence HIV/AIDS

TERMINATED NA

Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)

NCT01122186

HIV Medication Adherence Methamphetamine Use Sexual Risk +2 more

COMPLETED NA

Improving HIV and Alcohol-Related Outcomes Among HIV+ Persons in Clinic Settings

NCT02390908

HIV Alcohol Use Medication Adherence

COMPLETED NA

Reducing Alcohol Dependence Among HIV-Positive Individuals

NCT02501057

Alcohol Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental and Behavioral Disorders Due to Harmful Drug Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessors blind to randomization outcomes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HealthCall +Motivational Interviewing

Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc). The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

Group Type ACTIVE_COMPARATOR

HealthCall and Motivational Interviewing

Intervention Type BEHAVIORAL

Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc). The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

Motivational Interviewing (MI)

The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

Group Type ACTIVE_COMPARATOR

Motivational Interviewing (MI)

Intervention Type BEHAVIORAL

The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

HIV/AIDS health education - DVD control

HIV/AIDS health education - DVD control. The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.

Group Type PLACEBO_COMPARATOR

HIV/AIDS health education

Intervention Type BEHAVIORAL

The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HealthCall and Motivational Interviewing

Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc). The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

Intervention Type BEHAVIORAL

Motivational Interviewing (MI)

The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk

Intervention Type BEHAVIORAL

HIV/AIDS health education

The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All research volunteers will be 18 and older and HIV positive. We will include participants whose primary drug is non-injection use of cocaine, opioids including heroin, or methamphetamines and current use in the past 30 days \> 4 days. Participants will need to complete a medically supervised detoxification if such detoxification is required.

Exclusion Criteria

* Excluded are research volunteers for whom participation would not be clinically appropriate, who clearly could not participate. Psychotic, suicidal or homicidal patients require clinical management that is too intensive for this study, and we have no evidence that MI+HealthCall would be effective among injection drug users. Leaving New York precludes follow-up. Gross psychomotor/cognitive impairments that may hinder patients' HealthCall use. Hearing and severe vision impairments that preclude telephone use precludes randomization to MI+HealthCall.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No