Clinical trial NCT01884233: Cell Phone Technology Targeting ART Adherence and Drug Use
Official title: Cell Phone Technology Targeting ART Adherence and Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Opioid Abuse
Keywords: HIV
Opioid Abuse
Mobile technology
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-06-21
Enrollment: 62
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 objective of the current research is to improve treatment for injection opioid users by augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.

Detailed description: the specific aims of this research are 1) To develop and refine, with user feedback, a cognitive behavioral therapy-based text-messaging intervention (TXT-CBT) for HIV-infected adults with opioid dependence; 2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of TXT-CBT over and above standard care (SC) on opioid use, HIV medication adherence, and healthcare outcomes. Both SC and SC+TXT-CBT participants will be assessed at baseline, treatment-end, and 12 weeks post-treatment; and 3) To examine potential mechanisms of action of TXT-CBT, including self-efficacy, affect regulation, and social support. The investigators hypothesize that TXT-CBT delivered in conjunction with SC will produce greater reductions in opioid use and HIV-risk behaviors, and will improve HIV treatment regimen adherence, relative to MM alone. Further, the investigators expect that SC+TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes. TXT-CBT incorporates specific substance- and adherence-focused cognitive therapy techniques with a concurrent emphasis on reducing HIV-risk behaviors. By providing support to maximize HIV treatment regimen adherence, coupled with coping skills to address withdrawal symptoms and stress, two important factors in opioid relapse, TXT-CBT may provide a promising, cost-effective, and easily deployable augmenting strategy for the treatment of opioid users who are HIV-infected.

Eligibility criteria: Inclusion criteria for participants in both Phase I and Phase II will be:

1. Age 18 or older;
2. DSM-IV diagnosis of Opioid Dependence;
3. HIV-infected serostatus;
4. Able to provide informed consent;
5. Willing and able to participate in study procedures,
6. 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.

Exclusion Criteria:

1. Lack of proficiency in English;
2. Currently homeless (unless residing in a recovery home for which contact information can be provided);
3. Dependence on an illicit substance for which medical detoxification is imminently needed.
4. 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.

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Primary outcomes:
measure: Change in Substance Use
timeFrame: The ASI is to be collected at baseline (week 0), treatment-end (week 12), and Follow-Up (wek 24). UDS is collected weekly during the intervetion.
measure: Change in HIV Risk Behaviors
timeFrame: RBS will be collected at baseline (week 0), treatment-end (week 12), and FU (week 24)
measure: Change in treatment adherence
timeFrame: Pill bottle collection will be weekly during the intervention. Pill counts and Viral load will be collected at baseline (week 0), treatment end (week 12), and FU (week 24).
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: week 0, week 12 and week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Isap Ocrc
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Suzette Glasner, PhD
role: PRINCIPAL_INVESTIGATOR
References: