HIV InfectionsALCTXTNCT02603471
Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
A study testing Informational group and Text Messaging CBT (TXT-CBT) in people with HIV Infections and Alcohol Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Alcohol Dependence
- What is being tested?
- Informational group and Text Messaging CBT (TXT-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older;
- DSM-IV diagnosis of Alcohol Dependence;
- Use of 5 or more standard drinks per drinking day for men or 4 or more for women (over the past 30 days);
- HIV-infected serostatus;
- Able to provide informed consent;
- Willing and able to participate in study procedures,
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- 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.
- Adherent to <90% of antiretroviral therapy regimen, as determined by the medication adherence screening procedure
- 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.
- Owning a cell phone. Participants are required to own their phone and cannot use someone else's phone.
Who cannot join
- 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).
- 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.
- Has undergone more than one inpatient medical detoxification treatment;
- Lack of proficiency in English;
- Currently homeless (unless residing in a recovery home for which contact information can be provided);
- 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.
- Not currently taking naltrexone in its injectable form (Vivitrol) or not interested in taking/receiving information about vivitrol or not interested in taking vivitrol
- Adherent to > or =90% of antiretroviral therapy regimen, as determined by the medication adherence screening procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- HIV Infections, Alcohol Dependence
- Being tested
- Informational group, Text Messaging CBT (TXT-CBT)
- Keywords
- HIV infections, Alcohol dependence, Mobile Technology
- Medical subject headings
- HIV Infections, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational groupOther
A pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention.
Text Messaging CBT (TXT-CBT)Behavioural
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 intervention phase to answer any technical questions and ensure that the intervention program is working properly.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging CBT (TXT-CBT) | Experimental | 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 weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly. Receives: Behavioral: Text Messaging CBT (TXT-CBT) |
| Informational group | Active comparator | A pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition. Receives: Other: Informational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Outcome Measure: Substance Use (ASI)
Addiction Severity Index (ASI) is an instrument widely used in addiction research to quantify drug use frequency and related problem areas.
Measured: baseline (week 0), treatment-end (week 12), and Follow-Up (FU) (week 24)
Change Outcome Measure: HIV Risk (RBRA)
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' change in RBRA scores is being assessed from each timepoint to the next.
Measured: RBRA will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
Change Outcome Measure: Adherence Measures
ART Adherence. The investigator will use monthly phone-based unannounced pill counts (UPCs).
Measured: Baseline, Weeks 4,8,12,16,20 and 24
Change Outcome Measure: Substance Use (UDS)
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 (heroin and prescription opioids) will be conducted. The UDS will test for the presence of: amphetamines, benzodiazepines, methadone, cocaine, methamphetamine, morphine (heroin), hydrocodone (Vicodin), oxycodone (OxyContin), and marijuana. The participants' change in substance use over time (as assessed by the ASI and UDS results) is being assessed from each timepoint to the next.
Measured: UDS is collected at baseline, week 4, week 8, week 12 and week 24
Change Outcome Measure: Viral Load
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 (week 24) via chart review from the participant's medical provider.
Measured: at baseline (week 0), treatment end (week 12), and FU (week 24).
Secondary outcomes (1)
Change in Quality of Life
Data concerning health-related quality of life during and after treatment will be collected using the SF-12 Health Survey. It measures eight health domains, and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.
Measured: Weeks 0,12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Suzette Glasner, PhD, Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603471
- Sponsor's protocol ID
- ALCTEXT
- Acronym
- ALCTXT
- Status last verified
- Apr 2022
- First submitted
- 15 Jul 2014
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Glasner S, Chokron Garneau H, Ang A, Ray L, Venegas A, Rawson R, Kalichman S. Preliminary Efficacy of a Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence: A Randomized Clinical Trial. PLoS One. 2020 Mar 12;15(3):e0229557. doi: 10.1371/journal.pone.0229557. eCollection 2020.
PubMed 32163431
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
- ClinicalTrials.gov ID
- NCT02603471
- Acronym / sponsor ID
- ALCTXT / ALCTEXT
- Conditions
- HIV Infections, Alcohol Dependence
- Keywords
- HIV infections, Alcohol dependence, Mobile Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging CBT (TXT-CBT) | Experimental | Behavioral: Text Messaging CBT (TXT-CBT)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 weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly. |
| Informational group | Active comparator | Other: Informational groupA pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older;
- DSM-IV diagnosis of Alcohol Dependence;
- Use of 5 or more standard drinks per drinking day for men or 4 or more for women (over the past 30 days);
- HIV-infected serostatus;
- Able to provide informed consent;
Key exclusion criteria (8 listed)
- 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).
- 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.
- Has undergone more than one inpatient medical detoxification treatment;
- Lack of proficiency in English;
- Currently homeless (unless residing in a recovery home for which contact information can be provided);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational groupA pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention. | Other | Informational group |
| Text Messaging CBT (TXT-CBT)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 intervention phase to answer any technical questions and ensure that the intervention program is working properly. | Behavioural | Text Messaging CBT (TXT-CBT) |
Primary outcome
Change Outcome Measure: Substance Use (ASI)
Time frame: baseline (week 0), treatment-end (week 12), and Follow-Up (FU) (week 24)
Addiction Severity Index (ASI) is an instrument widely used in addiction research to quantify drug use frequency and related problem areas.
Change Outcome Measure: HIV Risk (RBRA)
Time frame: RBRA will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
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' change in RBRA scores is being assessed from each timepoint to the next.
Change Outcome Measure: Adherence Measures
Time frame: Baseline, Weeks 4,8,12,16,20 and 24
ART Adherence. The investigator will use monthly phone-based unannounced pill counts (UPCs).
Change Outcome Measure: Substance Use (UDS)
Time frame: UDS is collected at baseline, week 4, week 8, week 12 and week 24
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 (heroin and prescription opioids) will be conducted. The UDS will test for the presence of: amphetamines, benzodiazepines, methadone, cocaine, methamphetamine, morphine (heroin), hydrocodone (Vicodin), oxycodone (OxyContin), and marijuana. The participants' change in substance use over time (as assessed by the ASI and UDS results) is being assessed from each timepoint to the next.
Change Outcome Measure: Viral Load
Time frame: at baseline (week 0), treatment end (week 12), and FU (week 24).
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 (week 24) via chart review from the participant's medical provider.
1 secondary outcome
Change in Quality of Life
Time frame: Weeks 0,12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 32163431Glasner S, Chokron Garneau H, Ang A, Ray L, Venegas A, Rawson R, Kalichman S. Preliminary Efficacy of a Cognitive Behavioral Therapy Text Messaging Intervention Targeting Alcohol Use and Antiretroviral Therapy Adherence: A Randomized Clinical Trial. PLoS One. 2020 Mar 12;15(3):e0229557. doi: 10.1371/journal.pone.0229557. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzette Glasner, PhD principal investigator
UCLA Integrated Substance Abuse Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational group and Text Messaging CBT (TXT-CBT) in people with HIV Infections and Alcohol Dependence, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Outcome Measure: Substance Use (ASI) (time frame: baseline (week 0), treatment-end (week 12), and Follow-Up (FU) (week 24)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.