HIV Medication Adherence in Underserved Populations

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02392884

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome	Behavioral: Cognitive Rehabilitation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Change in Medication Adherence in 6 Months (adherence score) [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.