Substance Abuse Clinical Trial
Official title:
Targeting Prospective Memory to Improve HIV Adherence in Adolescents at Risk for Substance Abuse
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
| Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT03129334 -
Preventing Prescription Drug Abuse in Middle School Students
|
N/A | |
| Completed |
NCT02733003 -
Implementation Research for Vulnerable Women in South Africa
|
N/A | |
| Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
| Completed |
NCT02573948 -
Feasibility of Interventions on People Who Inject Drugs in Vietnam
|
||
| Withdrawn |
NCT01523444 -
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
|
Phase 3 | |
| Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
| Completed |
NCT01481428 -
Reducing High Risk Behavior in Treatment Court
|
Phase 1 | |
| Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
| Completed |
NCT01601743 -
Exercise as a Behavioral Treatment for Cocaine Dependence
|
N/A | |
| Active, not recruiting |
NCT00847548 -
Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
|
N/A | |
| Completed |
NCT01614015 -
Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial
|
Phase 2 | |
| Withdrawn |
NCT01228890 -
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
|
Phase 3 | |
| Completed |
NCT01621334 -
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
|
Phase 1 | |
| Completed |
NCT00841711 -
Transitions: Linkages From Jail To Community
|
N/A | |
| Completed |
NCT00717444 -
Healthy Activities for Prize Incentives
|
N/A | |
| Completed |
NCT00685074 -
Computer-based Brief Intervention for Perinatal Substance Abuse
|
Phase 1/Phase 2 | |
| Completed |
NCT01465490 -
Monitoring and Feedback in Substance Abuse Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT01188434 -
Integrating Interventions for Maternal Substance Abuse
|
Phase 1 |