Los Angeles, California 90025


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

TBD


NCT ID:

NCT02603471


Secondary ID:


Study Acronym:

ALCTXT


Brief Title:

Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use


Official Title:

Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Data and Safety Monitoring Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Suzette Glasner-Edwards, PhD
Principal Investigator
UCLA Integrated Substance Abuse Programs
Primary Contact:Anne Bellows Lee, MSW
3102675232
ABellows@mednet.ucla.edu
Backup Contact:Helene Chokron Garneau, MPH
310-570-0897
hchokr@ucla.edu

Study Dates

Start Date:July 2014
Completion Date:December 2015
Completion Type:Anticipated
Primary Completion Date:December 2015
Primary Completion Type:Anticipated
Verification Date:November 2015
Last Changed Date:November 10, 2015
First Received Date:July 15, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change Outcome Measure: Substance Use (ASI)
Time Frame:baseline (week 0), treatment-end (week 12), and Follow-Up (FU) (week 24)
Safety Issues:False
Description:Addiction Severity Index (ASI) is an instrument widely used in addiction research to quantify drug use frequency and related problem areas.
Outcome Type:Primary Outcome
Measure:Change Outcome Measure: HIV Risk (RBRA)
Time Frame:RBRA will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
Safety Issues:False
Description:Risk Behavior Survey (RBRA): The RBRA is a brief interview assessing involvement in HIV risk behaviors in the areas of drug use and sex in the previous 30 days. Additional items include whether the sexual partner uses or injects drugs. The participants' c
Outcome Type:Primary Outcome
Measure:Change Outcome Measure: Adherence Measures
Time Frame:Baseline, Weeks 4,8,12,16,20 and 24
Safety Issues:False
Description:ART Adherence. The investigator will use monthly phone-based unannounced pill counts (UPCs).
Outcome Type:Primary Outcome
Measure:Change Outcome Measure: Substance Use (UDS)
Time Frame:UDS is collected at baseline, week 4, week 8, week 12 and week 24
Safety Issues:False
Description:Urine Drug Screen (UDS). Urine drug screens will be collected monthly using temperature controlled test cups. An FDA-approved one-step test will be used. During the 12-week treatment period, one full-screen panel and two panels only testing for opioids (h
Outcome Type:Primary Outcome
Measure:Change Outcome Measure: Viral Load
Time Frame:at baseline (week 0), treatment end (week 12), and FU (week 24).
Safety Issues:False
Description:Viral load will serve as a biological indicator of adherence. Consistent with the typical frequency with which viral load is assessed in clinical settings, data concerning viral load will be collected at baseline (week 0), treatment end (week 12), and FU
Outcome Type:Secondary Outcome
Measure:Quality of Life
Time Frame:Weeks 0,12 and 24
Safety Issues:False
Description:We will collect data concerning health-related quality of life during and after treatment.

Study Interventions

Intervention Type:Other
Name:Informational group
Description:A pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention.
Arm Name:Informational group
Intervention Type:Behavioral
Name:Text Messaging CBT (TXT-CBT)
Description:Those assigned to TXT-CBT will be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have initial meeting with a CBT clinician to review the core CBT concepts for promoting ART adherence. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekly at data collection visits throughout the int
Arm Name:Text Messaging CBT (TXT-CBT)

Study Arms

Study Arm Type:Experimental
Arm Name:Text Messaging CBT (TXT-CBT)
Description:This condition will receive CBT based text messaging (TXT-CBT). Those assigned to TXT-CBT will also be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have an initial meeting with a CBT clinician to review the Life-Steps concepts. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekl
Study Arm Type:Active Comparator
Arm Name:Informational group
Description:A pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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