Clinical trial NCT02603471: Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
Official title: Cell Phone Technology Targeting ART and Naltrexone Adherence and Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Alcohol Dependence
Keywords: HIV infections
Alcohol dependence
Mobile Technology
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change Outcome Measure: Substance Use (ASI)
timeFrame: baseline (week 0), treatment-end (week 12), and Follow-Up (FU) (week 24)
measure: Change Outcome Measure: HIV Risk (RBRA)
timeFrame: RBRA will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
measure: Change Outcome Measure: Adherence Measures
timeFrame: Baseline, Weeks 4,8,12,16,20 and 24
measure: Change Outcome Measure: Substance Use (UDS)
timeFrame: UDS is collected at baseline, week 4, week 8, week 12 and week 24
measure: Change Outcome Measure: Viral Load
timeFrame: at baseline (week 0), treatment end (week 12), and FU (week 24).
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Weeks 0,12 and 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Programs
state: California
Study officials:
affiliation: UCLA Integrated Substance Abuse Programs
name: Suzette Glasner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.