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
  Purpose

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.

Condition Intervention Phase
Adherence
Substance Abuse
Behavioral: PM Component Text Reminders
Behavioral: Traditional Text Reminders
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 194
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Traditional Text Reminders
There will be a single face-to-face session followed by traditional text reminders.
Behavioral: Traditional Text Reminders
Traditional text reminders include: "Take your medication."

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959217

Contacts
Contact: Angulique Y Outlaw, PhD (313) 745-3218 aoutlaw@med.wayne.edu
Contact: Veronica Connors-Burge, MSEd 313-577-8788 vconners@med.wayne.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093-0553
Contact: Steven P Woods, Ph.D.    619-543-5004    spwoods@ucsd.edu   
Principal Investigator: Steven P Woods, PhD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Angulique Y Outlaw, Ph.D.    313-745-3218    aoutlaw@med.wayne.edu   
Contact: Veronica Connors-Burge, MSEd    (313) 577-8788    vconners@med.wayne.edu   
Principal Investigator: Sylvie Naar-King, Ph.D.         
Sponsors and Collaborators
Wayne State University
University of California, San Diego
Investigators
Principal Investigator: Sylvie Naar-King, Ph.D. Wayne State University
Principal Investigator: Steven P Woods, Ph.D. University of California, San Diego
  More Information

Publications:
Responsible Party: Sylvie Naar-King, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01959217     History of Changes
Other Study ID Numbers: 1R01DA034497
Study First Received: August 30, 2013
Last Updated: October 8, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Wayne State University:
HIV
Substance Abuse
Prospective Memory

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014