Cell Phone Technology Targeting ART Adherence and Drug Use
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS, Psychiatric |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2012 |
End Date: | January 2016 |
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.
augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse
prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.
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.
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.
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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