Acquired Immunodeficiency Syndrome, Human Immunodeficiency Virus
Conditions
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
Brief summary
The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactKimberly L Smith, PsyD
Backup ContactEnrique Lopez, PsyD
Outcome results
None listed