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Completed

NCT Number: NCT01312181

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

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.

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Key information

Conditions

Mental and Behavioral Disorders Due to Harmful Drug Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Advanced Medicine, Mt. Sinai services, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HealthCall and Motivational Interviewing

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)

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

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.

Primary outcomes

  1. Total Number of Days of Primary Drug Used in the Prior 30 Days

    Time frame: Assessed at end of treatment (60 days)

    One primary study outcome was frequency of drug use, represented by the total number of days of primary drug used in the prior 30 days (NumDU) as derived from the Time Line Follow Back (TLFB).

  2. Total Dollar Value of Primary Drug Used in the Prior 30 Days

    Time frame: Assessed at end of treatment (60 days)

    One primary study outcome was quantity of drug used in the prior 30 days, represented by the total dollar amount of primary drug used (QuantU) in the prior 30 days, as derived from the Time Line Follow Back (TLFB).

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 10, 2011
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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