Targeting PM to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
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|ClinicalTrials.gov Identifier: NCT01959217|
Recruitment Status : Unknown
Verified October 2013 by Sylvie Naar-King, Wayne State University.
Recruitment status was: Recruiting
First Posted : October 9, 2013
Last Update Posted : October 9, 2013
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 or disease||Intervention/treatment||Phase|
|Adherence Substance Abuse||Behavioral: PM Component Text Reminders Behavioral: Traditional Text Reminders||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
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."
- Change in Medication Adherence and Viral Load [ Time Frame: Change from baseline measurement to 3-months, and change from 3-months to 6-months ]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.
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
|Contact: Angulique Y Outlaw, PhD||(313) firstname.lastname@example.org|
|Contact: Veronica Connors-Burge, MSEdemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Veronica Connors-Burge, MSEd (313) 577-8788 firstname.lastname@example.org|
|Principal Investigator: Sylvie Naar-King, Ph.D.|
|Principal Investigator:||Sylvie Naar-King, Ph.D.||Wayne State University|
|Principal Investigator:||Steven P Woods, Ph.D.||University of California, San Diego|