HIV Medication Adherence in Underserved Populations

Not Applicable

• Conditions: Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome
• Interventions: Behavioral: Cognitive Rehabilitation

• Registration Number: NCT02392884
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Posted: 2015-03-19
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compensatory Cognitive Training	Cognitive Rehabilitation	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.
EON-MEM	Cognitive Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States