Clinical trial NCT02392884: HIV Medication Adherence in Underserved Populations
Official title: A Cognitive Rehabilitation Program to Promote Treatment Adherence for Individuals Who Are HIV Positive With Mild Neurocognitive Difficulties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Medication Adherence in 6 Months (adherence score)
timeFrame: 1,2, 3, 6 months
Secondary outcomes:
measure: Change in Self Efficacy in 6 Months (subjective self-control score)
timeFrame: 1, 2, 3, 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Kimberly Smith, PsyD
role: PRINCIPAL_INVESTIGATOR
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