Overview

This trial is active, not recruiting.

Condition mental and behavioral disorders due to multiple drug use and use of other psychoactive substances: harmful use
Treatments healthcall and motivational interviewing, motivational interviewing (mi), hiv/aids health education
Phase phase 1/phase 2
Sponsor Research Foundation for Mental Hygiene, Inc.
Start date June 2011
End date August 2015
Trial size 390 participants
Trial identifier NCT01312181, R01 DA024606

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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).
healthcall and motivational interviewing
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.
(Active Comparator)
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)
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.
(Placebo Comparator)
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.
hiv/aids health education
A basic behavioral intervention used in the 3 arms including the Motivational Interview (MI), the two components of HealthCall (IVR, personalized feedback) and the advice+DVD educational control arm.

Primary Outcomes

Measure
The primary outcome variable is drug use, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
time frame: Assessed at baseline, 30 and 60 days, 3,6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care
Principal investigator Efrat Aharonovich, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Research Foundation for Mental Hygiene, Inc..