HIV Medication Adherence in Underserved Populations

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02392884
• Other study ID #: Pro00033072
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 18, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Cedars-Sinai Medical Center
• Contact: Kimberly L Smith, PsyD
• Phone: 310-248-7682
• Email: kimberly.smith2[@]cshs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No