HIV Medication Adherence in Underserved Populations

NCT02392884 | Unknown DMC

• 1 other identifier: Pro00033072
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1,2, 3, 6 months

Secondary Outcomes (1)

• Change in Self Efficacy in 6 Months (subjective self-control score)

  1, 2, 3, 6 months

Study Arms (3)

EON-MEM

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Rehabilitation

Compensatory Cognitive Training

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Rehabilitation

Psychoeducation

NO INTERVENTION

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 BEHAVIORAL

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.

Compensatory Cognitive Training; EON-MEM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (44)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kimberly Smith, PsyD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly L Smith, PsyD

CONTACT

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

Enrique Lopez, PsyD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Posstdoctoral Scientist

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 19, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

US (1)