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

Primary Purpose

Adherence, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PM Component Text Reminders
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adherence focused on measuring HIV, Substance Abuse, Prospective Memory

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego
  • Wayne State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PM Component Text Reminders

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Medication Adherence
Viral load measurement will be obtained by a blood sample to measure medication adherence

Secondary Outcome Measures

Full Information

First Posted
August 30, 2013
Last Updated
October 8, 2018
Sponsor
Wayne State University
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01959217
Brief Title
Targeting PM to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
Official Title
Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 13, 2012 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Substance Abuse
Keywords
HIV, Substance Abuse, Prospective Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PM Component Text Reminders
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
PM Component Text Reminders
Intervention Description
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 Measure Information:
Title
Change in Medication Adherence
Description
Viral load measurement will be obtained by a blood sample to measure 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Naar-King, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven P Woods, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angulique Y Outlaw, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0553
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23417497
Citation
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.
Results Reference
background
PubMed Identifier
27687290
Citation
Faytell MP, Doyle K, Naar-King S, Outlaw A, Nichols S, Twamley E, Woods SP. Calendaring and alarms can improve naturalistic time-based prospective memory for youth infected with HIV. Neuropsychol Rehabil. 2018 Sep;28(6):1038-1051. doi: 10.1080/09602011.2016.1236733. Epub 2016 Sep 30.
Results Reference
result
PubMed Identifier
26690580
Citation
Faytell MP, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Casaletto KB, Woods SP. Visualisation of future task performance improves naturalistic prospective memory for some younger adults living with HIV disease. Neuropsychol Rehabil. 2017 Dec;27(8):1142-1155. doi: 10.1080/09602011.2015.1122636. Epub 2015 Dec 21.
Results Reference
result
PubMed Identifier
24834469
Citation
Woods SP, Doyle KL, Morgan EE, Naar-King S, Outlaw AY, Nichols SL, Loft S. Task importance affects event-based prospective memory performance in adults with HIV-associated neurocognitive disorders and HIV-infected young adults with problematic substance use. J Int Neuropsychol Soc. 2014 Jul;20(6):652-62. doi: 10.1017/S1355617714000435. Epub 2014 May 16.
Results Reference
result
PubMed Identifier
25116075
Citation
Loft S, Doyle KL, Naar-King S, Outlaw AY, Nichols SL, Weber E, Casaletto KB, Woods SP. Allowing brief delays in responding improves event-based prospective memory for young adults living with HIV disease. J Clin Exp Neuropsychol. 2014;36(7):761-72. doi: 10.1080/13803395.2014.942255. Epub 2014 Aug 13.
Results Reference
result

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

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