HIV
Conditions
Keywords
HIV, Medication Adherence, Working Memory
Brief summary
The proposed study will test the efficacy of a cognitive training program to improve working memory in a sample of HIV-infected persons. Investigators will assign 40 HIV-infected adults with poor medication adherence to one of two conditions (20/group): the experimental cognitive training intervention or a control training condition. Participants will complete 12 training sessions across 10 weeks and will complete assessments at baseline and post-training. The specific aims are to: 1. Investigate the effects of the cognitive training intervention on working memory and delay discounting in HIV-infected persons. Hypothesis 1: Participants assigned to active cognitive training, compared to those in the attention-matched control group, will have greater improvements in working memory and reductions in delay discounting. 2. Characterize adherence to antiretroviral medications in this population and examine medication adherence after cognitive training. Hypothesis 2: Participants assigned to active cognitive training, compared to those in the attention-matched control group, will have greater improvements in medication adherence.
Detailed description
This study tests the feasibility and preliminary efficacy of a computerized cognitive training program to improve working memory and decrease impulsivity among HIV-infected individuals with poor medication adherence. The specific aims are to: (1) Investigate the effects of the cognitive training intervention on working memory and delay discounting in HIV-infected persons; and (2) Characterize adherence to antiretroviral medications in this population and examine medication adherence after cognitive training. The research design includes two parts: an eligibility screening and the Cognitive Training study. In Part 1, Eligibility Screening, participants will complete a 2-3 hour battery of standardized measures to assess for study eligibility. Eligible individuals will then be invited to enroll in Part 2, Cognitive Training Study. Part 1 of the study will involved screening approximately 60 participants, with an estimated eligibility rate of 67% for Part 2. In Part 2, participants will be assigned to one of two groups (active cognitive training or control training; 20 participants per group) and will complete 12 training sessions over 10 weeks. Participants assigned to the active cognitive training group will complete computerized modules designed to enhance working memory, while those assigned to the attention-matched control group will complete inactive modules that are not designed to enhance memory. All Part 2 participants will complete assessments at baseline and post-training to evaluate the impact of the training program.
Interventions
DEVICEControl (CON)
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV infection, diagnosed for \> 6 months * Currently on treatment with antiretroviral medications for \> 3 months * Self-reported medication adherence at less than 90% * Lives within 15 miles of the research site in stable housing and with no plans to move from the area in the next 3 months
Exclusion criteria
* Current substance use disorder * Any drug use other than alcohol or marijuana in the past year * Pregnancy * English non-fluency or illiteracy * ≤ 8th grade education * serious neurological disorders, including HIV dementia * traumatic brain injury * severe mental illness or acute psychiatric distress * impaired mental status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Memory | Baseline and 10 weeks | Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Delay Discounting | Baseline and 10 weeks | Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting. Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., Would you prefer $54 today or $80 in 30 days?). Participants' hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days. K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses. A higher rank indicates greater delay discounting. |
Other
| Measure | Time frame |
|---|---|
| Change in Mean Percent Adherence Across All Antiretroviral Medications | Baseline and 10 weeks |
Countries
United States
Participant flow
Recruitment details
Adult persons living with HIV were recruited from the Durham area between January 2015 and May 2016 via flyers and brochures at community-based organizations and infectious diseases clinics.
Pre-assignment details
Interested persons completed a comprehensive in-person eligibility screen prior to group assignment. 33 participants completed the in-person screen, and 12 were not eligible (5 had no memory impairment, 3 had a current substance use disorder, 2 had a history of brain injury, 1 had severe mental illness, and 1 was not interested).
Participants by arm
| Arm | Count |
|---|---|
| Active Cognitive Training (ACT) The ACT group will complete 12 individual sessions across 6-10 weeks. Sessions will utilize four commercially available memory-training programs from PSSCogRehab 2012, published by Psychological Software Service. The four programs used will be: (1) Sequence recall of digits - auditory (SRD-A), (2) Sequenced Recall Reversed Digits - Auditory (SRRD-A), (3) Sequenced Recall of Words - Visual (SRW-V), and (4) Verbal memory - categorizing (VM-C). In each training session, participants will complete each of the four memory training programs twice.
Active Cognitive Training (ACT) | 11 |
| Control (CON) The CON group will also complete 12 total sessions across 6-10 weeks. The same four computer programs from PSSCogRehab 2012, published by Psychological Software Service, will be used in the control group sessions. However, the control program will identify the correct responses to participants, such that they do not need to engage their working memory to answer the questions correctly.
Control (CON) | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Active Cognitive Training (ACT) | Control (CON) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 51.27 years STANDARD_DEVIATION 8.37 | 44.20 years STANDARD_DEVIATION 13.01 | 47.90 years STANDARD_DEVIATION 11.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 10 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Change in Working Memory
Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks.
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cognitive Training (ACT) | Change in Working Memory | 51.33 mean T score on working memory tests | Standard Error 2.69 |
| Control (CON) | Change in Working Memory | 43.15 mean T score on working memory tests | Standard Error 2.99 |
p-value: 0.013ANCOVA
Secondary
Change in Delay Discounting
Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting. Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., Would you prefer $54 today or $80 in 30 days?). Participants' hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days. K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses. A higher rank indicates greater delay discounting.
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cognitive Training (ACT) | Change in Delay Discounting | 8.62 Mean K value rank for MCQ | Standard Deviation 1.76 |
| Control (CON) | Change in Delay Discounting | 8.81 Mean K value rank for MCQ | Standard Deviation 1.52 |
p-value: 0.274ANCOVA
Other Pre-specified
Change in Mean Percent Adherence Across All Antiretroviral Medications
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cognitive Training (ACT) | Change in Mean Percent Adherence Across All Antiretroviral Medications | 94.09 Percent of doses | Standard Deviation 13.57 |
| Control (CON) | Change in Mean Percent Adherence Across All Antiretroviral Medications | 95.11 Percent of doses | Standard Deviation 10.2 |
p-value: 0.41ANCOVA