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

NCT01959217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-10-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sylvie Naar-King, Ph.D. · University of Florida

  • Steven P Woods, Ph.D. · University of Houston

  • Angulique Y Outlaw, Ph.D. · Wayne State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-13
Primary Completion
2018-05-31
Completion
2018-09-27

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959217 on ClinicalTrials.gov