HIV Medication Adherence in Underserved Populations

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

Detailed Description
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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.

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

Conditions
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Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Behavioral: Cognitive Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EON-MEM<br>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<br>* 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.<br>|
| Active Comparator: Compensatory Cognitive Training<br>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<br>* 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.<br>|
| No Intervention: Psychoeducation<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1, 2, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minority Health, Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Cognitive Rehabilitation, Vulnerable Populations, Underserved, Patients, Medication Adherence, Medication Compliance, Medication Non-compliance, Medication Persistence, Medication Non-Adherence