Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2014
End Date:December 2015
Contact:Anne Bellows Lee, MSW
Email:ABellows@mednet.ucla.edu
Phone:3102675232

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The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone,
is a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral
support program delivered via text-messaging.

It is expected that the text messaging intervention will reduce alcohol use and HIV-risk
behaviors. The investigators also hypothesize that the intervention will improve adherence
to HIV treatment and naltrexone.

To test the effects of the intervention on these target outcomes, 25 participants receiving
the text messaging intervention will be compared to 25 participants receiving an
informational pamphlet. The pamphlet will contain information about the importance of HIV
treatment adherence, reducing HIV risk behaviors, and health consequences associated with
alcohol use.

By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled
with coping skills to promote abstinence from alcohol, the text messaging intervention may
provide a promising, cost-effective, and easily deployable behavioral support program for
alcohol users who are HIV-infected.

The aims of this study are to: 1) implement and evaluate a 12-week cognitive behavioral
therapy (CBT) intervention using text messaging via mobile phone technology (ALC-TXT-CBT) to
reduce alcohol use, reduce HIV-risk behaviors and facilitate medication adherence in a
population of alcohol dependent adults with HIV-infection and 2) examine potential
mechanisms of action of ALC-TXT-CBT. The investigators hypothesize that ALC-TXT-CBT will
produce greater reductions in alcohol use and HIV-risk behaviors, and will improve HIV
treatment regimen and naltrexone (Vivitrol) adherence, relative to the control condition
(informational pamphlet).

Further, the investigators expect that ALC-TXT-CBT will facilitate greater changes in
negative affect, self-efficacy, and social support, and these changes will be associated
with substance use outcomes.

Inclusion Criteria:

1. Age 18 or older;

2. DSM-IV diagnosis of Alcohol Dependence;

3. Use of 5 or more standard drinks per drinking day for men or 4 or more for women
(over the past 30 days);

4. HIV-infected serostatus;

5. Able to provide informed consent;

6. Willing and able to participate in study procedures,

7. Good general health or, in the case of a medical/psychiatric condition needing
ongoing treatment, potential participant should be under the care of a physician who
provides documented willingness to continue participant's medical management and
coordinate care with the study physicians.

8. Adherent to <90% of antiretroviral therapy regimen, as determined by our medication
adherence screening procedure

9. Currently taking or interested in taking/receiving more information about naltrexone
in its injectable form (Vivitrol). Participants WILL NOT be prescribed or given
naltrexone as part of this study. Participants not currently on vivitrol will be
referred to a physician in the community to be evaluated for vivitrol eligibility and
to receive vivitrol if applicable.

10. Owning a cell phone. Participants are required to own their phone and cannot use
someone else's phone.

Exclusion Criteria:

1. Presence of serious medical condition that would, in the opinion of the study
physician, make participation medically hazardous (e.g., acute hepatitis, unstable
cardiovascular, liver or renal disease).

2. A current pattern of alcohol or sedative use, as assessed by the study physician,
which would preclude safe participation in the study and/or would likely require
imminent medical detoxification.

3. Has undergone more than one inpatient medical detoxification treatment;

4. Lack of proficiency in English;

5. Currently homeless (unless residing in a recovery home for which contact information
can be provided);

6. Presence of clinically significant psychiatric symptoms as assessed by MINI, such as
psychosis, acute mania, or suicide risk that would require immediate treatment or
make study compliance difficult.

7. Not currently taking naltrexone in its injectable form (Vivitrol) or not interested
in taking/receiving information about vivitrol or not interested in taking vivitrol

8. Adherent to > or =90% of antiretroviral therapy regimen, as determined by our
medication adherence screening procedure.
We found this trial at
1
site
Los Angeles, California 90024
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from
Los Angeles, CA
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