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HIV Medication Adherence in Underserved Populations

Primary Purpose

Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Cognitive Rehabilitation, Minority Health, Vulnerable Populations, Underserved, Patients, Medication Adherence, Medication Compliance, Medication Non-compliance, Medication Persistence, Medication Non-Adherence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult, age 18 and older.
  • Able and willing to provide written informed consent.
  • Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB).
  • Diagnosed as HIV seropositive within the last two years.
  • Willing and able to provide adequate information for locator purposes.

Exclusion Criteria:

  • Under the age of 18.
  • Have ever sustained a traumatic brain injury.
  • Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study.
  • Have a learning disability where they cannot read or write pass the third grade level.
  • Have an active substance dependence diagnosis.

Sites / Locations

  • Cedars Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

EON-MEM

Compensatory Cognitive Training

Psychoeducation

Arm Description

Intervention: Cognitive Rehabilitation and compensatory strategies will be taught to subjects to help them remember routes, viral load count, CD4 count, faces of providers and managing their schedules. Over the course of 5 visits, subjects will receive this intervention.

Cognitive Rehabilitation and physical reminders, such as calendars, smart phones, self-notes and other methods to help subjects remember to attend all medical appointments and take their HIV medication. Subject will be exposed to 5 sessions of this particular training.

The psychoeducation group, which aims to teach subjects the importance of taking medications and attending all doctor's appointment for HIV treatment. If you subjects are assigned to this group, they will be followed and receive the care generally followed for individuals with this condition.

Outcomes

Primary Outcome Measures

Change in Medication Adherence in 6 Months (adherence score)
Patients may experience an increase in treatment adherence. High scores indicate increased levels of adherence, while low scores reflect difficulties with treatment adherence.

Secondary Outcome Measures

Change in Self Efficacy in 6 Months (subjective self-control score)
Subjects may experience an increase in subjective self-control over their HIV treatment. High scores indicate high levels of perceived control over their treatment, while lower scores reflect a reduced amount of perceived self-efficacy over their treatment.

Full Information

First Posted
March 10, 2015
Last Updated
March 18, 2015
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02392884
Brief Title
HIV Medication Adherence in Underserved Populations
Official Title
A Cognitive Rehabilitation Program to Promote Treatment Adherence for Individuals Who Are HIV Positive With Mild Neurocognitive Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.
Detailed Description
Although antiretroviral therapy (ART) has proven extremely effective in the treatment of HIV and AIDS, the ability to effectively combat the disease is inconsequential when individuals do not take their medication as prescribed and do not attend their scheduled medical appointments. Non-adherence to effective ART and medical visits is widespread in the United States, especially among ethnic minorities. A recent study indicated that patients who miss a medical appointment in the first year of an HIV diagnosis show over twice the mortality rate of patients who attended all visits. This study is developed to investigate the relationship between HIV Associated Neurocognitive Disorder (HAND) and adherence to HIV treatment among traditionally marginalized populations. Participants will be administered a brief neuropsychiatric screener. Participants will be randomly enrolled one of two cognitive rehabilitation programs so they may learn compensatory cognitive strategies to remain treatment adherent, or they will be receive psychoeducation concerning the importance of taking their medications and regularly attending medical appointments. Participants will be tracked and followed-up with regarding their treatment adherence in regular intervals over the course of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome
Keywords
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Cognitive Rehabilitation, Minority Health, Vulnerable Populations, Underserved, Patients, Medication Adherence, Medication Compliance, Medication Non-compliance, Medication Persistence, Medication Non-Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EON-MEM
Arm Type
Active Comparator
Arm Description
Intervention: Cognitive Rehabilitation and compensatory strategies will be taught to subjects to help them remember routes, viral load count, CD4 count, faces of providers and managing their schedules. Over the course of 5 visits, subjects will receive this intervention.
Arm Title
Compensatory Cognitive Training
Arm Type
Active Comparator
Arm Description
Cognitive Rehabilitation and physical reminders, such as calendars, smart phones, self-notes and other methods to help subjects remember to attend all medical appointments and take their HIV medication. Subject will be exposed to 5 sessions of this particular training.
Arm Title
Psychoeducation
Arm Type
No Intervention
Arm Description
The psychoeducation group, which aims to teach subjects the importance of taking medications and attending all doctor's appointment for HIV treatment. If you subjects are assigned to this group, they will be followed and receive the care generally followed for individuals with this condition.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
Provide cognitive techniques and teach compensatory strategies that subjects can use to help them remember to attend appointments, take their medications regularly, increase attention (conversational and task) and concentration, increase cognitive flexibility, develop better problem-solving skills.
Primary Outcome Measure Information:
Title
Change in Medication Adherence in 6 Months (adherence score)
Description
Patients may experience an increase in treatment adherence. High scores indicate increased levels of adherence, while low scores reflect difficulties with treatment adherence.
Time Frame
1,2, 3, 6 months
Secondary Outcome Measure Information:
Title
Change in Self Efficacy in 6 Months (subjective self-control score)
Description
Subjects may experience an increase in subjective self-control over their HIV treatment. High scores indicate high levels of perceived control over their treatment, while lower scores reflect a reduced amount of perceived self-efficacy over their treatment.
Time Frame
1, 2, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult, age 18 and older. Able and willing to provide written informed consent. Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB). Diagnosed as HIV seropositive within the last two years. Willing and able to provide adequate information for locator purposes. Exclusion Criteria: Under the age of 18. Have ever sustained a traumatic brain injury. Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study. Have a learning disability where they cannot read or write pass the third grade level. Have an active substance dependence diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly L Smith, PsyD
Phone
310-248-7682
Email
kimberly.smith2@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Lopez, PsyD
Phone
310-423-4555
Email
enrique.lopez@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Smith, PsyD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly L Smith, PsyD
Phone
310-248-6782
Email
kimberly.smith2@cshs.org
First Name & Middle Initial & Last Name & Degree
Enrique Lopez, PsyD
Phone
310-423-4555
Email
Enrique.Lopez2@cshs.org

12. IPD Sharing Statement

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HIV Medication Adherence in Underserved Populations

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