Recruiting

HIV Medication

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02392884

Conditions

Human Immunodeficiency Virus

Acquired Immunodeficiency Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cognitive Rehabilitation

Study Details

Brief summary:

The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.

Conditions

Human Immunodeficiency Virus

Acquired Immunodeficiency Syndrome

Study ID

NCT02392884

Start date

Sep, 2014

Status verified date

Mar, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: EON-MEM

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.

active comparator: Compensatory Cognitive Training

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.

no intervention: Psychoeducation

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.

Interventions

Cognitive Rehabilitation

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

  • Change in Medication Adherence in 6 Months (adherence score) [ Time Frame: 1,2, 3, 6 months ]

Central Contacts and Locations

Central contacts

Kimberly L Smith, PsyD

310-248-7682kimberly.smith2@cshs.org

Enrique Lopez, PsyD

310-423-4555enrique.lopez@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Kimberly L Smith, PsyD

310-248-6782kimberly.smith2@cshs.org

Enrique Lopez, PsyD

310-423-4555Enrique.Lopez2@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 19, 2015

Last verified

Mar, 2015

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2015-03-19.