HIV Medication Adherence in Underserved Populations

March 18, 2015 updated by: Kimberly Smith, Cedars-Sinai Medical Center

A Cognitive Rehabilitation Program to Promote Treatment Adherence for Individuals Who Are HIV Positive With Mild Neurocognitive Difficulties

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Medication Adherence in 6 Months (adherence score)
Time Frame: 1,2, 3, 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self Efficacy in 6 Months (subjective self-control score)
Time Frame: 1, 2, 3, 6 months
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.
1, 2, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Kimberly Smith, PsyD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00033072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acquired Immunodeficiency Syndrome

Clinical Trials on Cognitive Rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe