N/A
N=240
HealthCall:Brief Intervention to Reduce Non-injecting Drug Use in HIV Primary Care Clinics
Mental and Behavioral Disorders Due to Harmful Drug Use
Bottom Line
View on ClinicalTrials.gov: NCT01312181 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Total Number of Days of Primary Drug Used in the Prior 30 Days — 5.07; 3.61; 4.73 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HealthCall and Motivational Interviewing (Behavioral); Motivational Interviewing (MI) (Behavioral); HIV/AIDS health education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Research Foundation for Mental Hygiene, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Days of Primary Drug Used in the Prior 30 Days |
5.07; 3.61; 4.73 | — |
| PRIMARY Total Dollar Value of Primary Drug Used in the Prior 30 Days |
6.70; 6.47; 6.56 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01312181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.