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Targeting PM to Improve HIV Adherence in Adolescents at Risk for Substance Abuse

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Wayne State University
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Sylvie Naar-King, Wayne State University
ClinicalTrials.gov Identifier:
NCT01959217
First received: August 30, 2013
Last updated: October 8, 2013
Last verified: October 2013

August 30, 2013
October 8, 2013
January 2013
January 2017   (final data collection date for primary outcome measure)
Change in Medication Adherence and Viral Load [ Time Frame: Change from baseline measurement to 3-months, and change from 3-months to 6-months ] [ Designated as safety issue: No ]
Hair specimen assays, The Visual Analogue Scale (VAS), and bi-weekly Unannounced Pill Counts (phone-based) will be used to measure medication adherence. Viral load measurement will be obtained by a blood sample.
Same as current
Complete list of historical versions of study NCT01959217 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Targeting PM to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse

Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. This multi-site phased (3 phases) study plans to translate basic cognitive neuroscience regarding prospective memory (PM) into a more potent adherence intervention for youth living with HIV (YLH).

The phases are:

Phase 1: To improve PM in basic laboratory tasks in YLH with and with out substance abuse.

  • Hypothesis 1: Manipulations in three theory-based components of PM (strategic encoding, self-monitoring and cue salience) will improve PM within each participant.

Phase 2: To conduct proof of concept studies of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.

  • Hypothesis 2: Using a multiple baseline across subjects design, adherence to ART will improve following initiation of the PM adherence intervention and will be maintained for 6 weeks after tapering of the intervention.
  • Hypothesis 2a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth with and without substance problems.

Phase 3: To conduct a pilot randomized clinical trial of the PM intervention compared to traditional text message reminders (comparison condition) in non-adherent youth stratified by substance use.

  • Hypothesis 3: Youth randomized to receive the PM intervention will show greater initial and sustained improvements in adherence and viral load compared to those randomized to the control condition.
  • Hypothesis 3a: We will explore trends in the data relative to substance abuse, but we anticipate that the intervention will show promise for both substance using and non substance using YLH warranting a larger clinical trial that can test for substance-related mediators and moderators of the intervention.

Medication adherence rates among youth living with HIV are inadequate to effectively manage the disease, and novel interventions grounded in basic behavioral sciences are needed. Emerging evidence suggests that prospective memory (PM) could represent an important piece of the puzzle. PM is defined as the neurocognitive capacity to successfully form, maintain, and execute an intention at a particular point in the future in response to a specific cue. This study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for YLH, a population at high risk for poor cognitive function, substance abuse, and poor adherence. While text message reminders are an increasingly popular adherence support, evidence of efficacy is equivocal particularly for the maintenance of adherence after reminders end. By using basic cognitive neuroscience to enhance the potency of technology-based interventions to improve PM for adherence tasks, we hope to achieve both greater initial gains as well as sustained improvements in adherence for youth with and without substance abuse

This multi-site phased study plans to translate basic cognitive neuroscience regarding PM into a more potent adherence intervention for youth living with HIV (YLH).

  • In Phase 1, we will conduct theory-driven laboratory studies to improve three components of PM using a within-subjects design and traditional cognitive neuroscience tasks (strategic encoding, monitoring, and cue salience) in 60 youth from clinics where the co-PIs are based (Detroit and San Diego).
  • In Phase 2, we will translate promising Phase 1 PM interventions to the youth's natural context to target adherence by combining them with text messaging, and test for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence (N=24; 12 with substance abuse and 12 without from Detroit).
  • In Phase 3, we will conduct a pilot randomized clinical trial comparing the technology-based PM adherence intervention to text message reminders (N=60 from Detroit and San Diego).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Adherence
  • Substance Abuse
  • Behavioral: PM Component Text Reminders
    The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text reminders will be determined by Phase 1.
  • Behavioral: Traditional Text Reminders
    Traditional text reminders include: "Take your medication."
  • Experimental: PM Component Text Reminders
    There will be a a single face-to-face intervention followed by tailored text reminders. The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text message reminders will be determined by Phase 1.
    Intervention: Behavioral: PM Component Text Reminders
  • Active Comparator: Traditional Text Reminders
    There will be a single face-to-face session followed by traditional text reminders.
    Intervention: Behavioral: Traditional Text Reminders
Weber E, Blackstone K, Woods SP. Cognitive neurorehabilitation of HIV-associated neurocognitive disorders: a qualitative review and call to action. Neuropsychol Rev. 2013 Mar;23(1):81-98. doi: 10.1007/s11065-013-9225-6. Epub 2013 Feb 16. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
194
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected
  • Ability to speak and understand English
  • Prescribed antiretroviral therapy for at least 24 weeks
  • Detectable viral load in the last month
  • Second detectable viral load in the previous 6 months
  • Prescribed a regimen with at least two active drugs at study entry
  • Regular access to a cell phone with text messaging.

Exclusion Criteria:

  • Not fluent in English
  • History of severe learning disability, mental retardation, major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression with psychotic features, etc.).
  • History of a neurological conditions that might influence cognitive functioning (e.g., traumatic brain injury with loss of consciousness > 30 min, central nervous system neoplasms, stroke, seizure disorders, etc.).
  • Participation in another adherence intervention trial
  • On ART due to pregnancy.
Both
16 Years to 24 Years
No
Contact: Angulique Y Outlaw, PhD (313) 745-3218 aoutlaw@med.wayne.edu
Contact: Veronica Connors-Burge, MSEd 313-577-8788 vconners@med.wayne.edu
United States
 
NCT01959217
1R01DA034497
Yes
Sylvie Naar-King, Wayne State University
Wayne State University
University of California, San Diego
Principal Investigator: Sylvie Naar-King, Ph.D. Wayne State University
Principal Investigator: Steven P Woods, Ph.D. University of California, San Diego
Wayne State University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP