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

Completed · Not applicable

Conditions studied: Adherence, Substance Abuse

In brief

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.

Key facts

Study ID

NCT01959217

Run by

Wayne State University

People needed

104

Starts

2012-12-13

Expected to finish

2018-09-27

Last updated by the study team

2018-10-10

Who can join

Age: 16 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Wayne State University — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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