HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by Research Foundation for Mental Hygiene, Inc.
Sponsor:
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
Efrat Aharonovich, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01312181
First received: March 9, 2011
Last updated: September 12, 2014
Last verified: September 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental and Behavioral Disorders Due to Multiple Drug Use and Use of Other Psychoactive Substances: Harmful Use |
Behavioral: HealthCall and Motivational Interviewing Behavioral: Motivational Interviewing (MI) Behavioral: HIV/AIDS health education |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HealthCall: Brief Intervention to Reduce Drug Use in HIV Primary Care |
Resource links provided by NLM:
Further study details as provided by Research Foundation for Mental Hygiene, Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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).
|
Behavioral: 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: 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
|
Behavioral: 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
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.
|
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312181
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312181
Contacts
| Contact: Efrat Aharonovich, PhD | ea2017@columbia.edu |
Locations
| United States, New York | |
| Institute for Advanced Medicine, Mt. Sinai services | Active, not recruiting |
| New York, New York, United States, 10032 | |
| Mt Sinai Spencer Cox Center for Health | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Rachel Wolfe, PhD 212-523-6500 RWolfe@chpnet.org | |
| Principal Investigator: Hannah Wolfe, PhD | |
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
| Principal Investigator: | Efrat Aharonovich, PhD | The New York State Psychiatric Institute and Columbia Univeristy |
More Information
Publications:
| Responsible Party: | Efrat Aharonovich, Resarch Scientist, Research Foundation for Mental Hygiene, Inc. |
| ClinicalTrials.gov Identifier: | NCT01312181 History of Changes |
| Other Study ID Numbers: | R01 DA024606-01 |
| Study First Received: | March 9, 2011 |
| Last Updated: | September 12, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Research Foundation for Mental Hygiene, Inc.:
|
Technology based intervention HIV primary care clinic Brief behavioral intervention Drug abuse |
ClinicalTrials.gov processed this record on March 03, 2015