NCT01959217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

5.5 years

First QC Date

August 30, 2013

Last Update Submit

October 8, 2018

Conditions

AdherenceSubstance Abuse

Keywords

HIVSubstance AbuseProspective Memory

Outcome Measures

Primary Outcomes (1)

  • Change in Medication Adherence

    Viral load measurement will be obtained by a blood sample to measure medication adherence

    Change from baseline measurement to 3-months, change from 3-months to 6-months, and change from baseline to 6 months

Study Arms (1)

PM Component Text Reminders

EXPERIMENTAL

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

Interventions

PM Component Text RemindersBEHAVIORAL

The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text reminders will be determined by Phase 1.

PM Component Text Reminders

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093-0553, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (5)

  • 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.

    PMID: 23417497BACKGROUND

  • 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.

    PMID: 27687290RESULT

  • 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.

    PMID: 26690580RESULT

  • 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.

    PMID: 24834469RESULT

  • 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.

    PMID: 25116075RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 30, 2013

First Posted

October 9, 2013

Study Start

December 13, 2012

Primary Completion

May 31, 2018

Study Completion

September 27, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)