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

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ClinicalTrials.gov Identifier: NCT01959217
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Angulique Outlaw, Wayne State University

Brief Summary:

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 without 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 antiretroviral therapy (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 additional proof of concept studies, based on Phase 2 findings, of a text-delivered PM intervention for taking ART in YLH with suboptimal adherence.

  • Hypothesis 3: 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 3a: Similar feasibility, tolerability, and adherence improvement trends will be seen in youth.

Condition or disease Intervention/treatment Phase
Adherence Substance Abuse Behavioral: PM Component Text Reminders Not Applicable

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 conducted 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 principal investigators (PIs) are located (Detroit and San Diego).
  • In Phase 2, we translated promising Phase 1 PM interventions to the youth's natural context, targeting adherence in combination 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 repeated the Phase 2 study (targeted adherence in combination with text message reminders and two-way assessment text messages, and tested for signals of efficacy using a multiple baseline design for YLH with suboptimal adherence; N=20; Detroit and national online recruitment).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
Actual Study Start Date : December 13, 2012
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Memory

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Medication Adherence [ Time Frame: Change from baseline measurement to 3-months, change from 3-months to 6-months, and change from baseline to 6 months ]
    Viral load measurement will be obtained by a blood sample to measure medication adherence



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959217


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093-0553
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
University of California, San Diego
Investigators
Principal Investigator: Sylvie Naar-King, Ph.D. University of Florida
Principal Investigator: Steven P Woods, Ph.D. University of Houston
Principal Investigator: Angulique Y Outlaw, Ph.D. Wayne State University

Publications of Results:
Other Publications:
Responsible Party: Angulique Outlaw, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01959217     History of Changes
Other Study ID Numbers: 1R01DA034497 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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