Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use

NCT ID: NCT02603471

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

HIV Infections; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Text Messaging CBT (TXT-CBT)

Intervention Type: BEHAVIORAL

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.

Informational group

A pamphlet with information about HIV, the importance of ART adherence, and relapse prevention will be provided to participants in this condition.

Group Type: ACTIVE_COMPARATOR

Informational group

Intervention Type: OTHER

A pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention.

Interventions

Informational group

A pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility 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 the 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 the medication adherence screening procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Suzette Glasner-Edwards

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzette Glasner, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA Integrated Substance Abuse Programs

Locations

UCLA Integrated Substance Abuse Programs

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32163431 (View on PubMed)

Other Identifiers

ALCTEXT

Identifier Type: -

Identifier Source: org_study_id