HIV-Associated Cognitive Motor ComplexTOPSNCT03122288
Individualized Cognitive Training in HIV
A study testing Individualized Cognitive Training in people with HIV-Associated Cognitive Motor Complex and Aging, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV-Associated Cognitive Motor Complex, Aging, Cognitive Impairment
- What is being tested?
- Individualized Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 27 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 40+ years
- English speaking
- Have HIV-Associated Neurocognitive Disorder (HAND)
Who cannot join
- Because the study requires several weeks, participants not living in stable housing (e.g., halfway house) will be excluded.
- Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
- Currently undergoing radiation or chemotherapy
- A history of brain trauma with a loss of consciousness greater than 30 minutes
- Legally blind or deaf
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35222
About this study
Official title: Individualized-Targeted Cognitive Training in Older Adults With HAND
Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular disease, hypertension, and insulin resistance which will further contribute to poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed when a person performs less than 1 to 2 SD below their normative mean (education \& age) on measures of two or more cognitive domains (e.g., attention, speed of processing, verbal memory, executive functioning). Yet, from the cognitive literature and prior studies, administering certain computerized cognitive training programs may improve specific cognitive domains in older adults and those with HIV. Such cognitive training programs may be effective in older adults with HIV and therefore investigators may be able to change the diagnosis of HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted Cognitive Training, or 2) a no-contact control group. The investigators will focus on those cognitive domains in which participants express an impairment and train them with the corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach using standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare adults who do receive individualized-targeted cognitive training to those who do not in order to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2: Determine whether improvements in HAND and/or everyday functioning over time mediate improvements in quality of life.
Read the detailed description
This research directly meets the goals of the NIH Cognitive and Emotional Health Project and the Healthy Brain Initiative which seek to "maintain or improve the cognitive performance of all adults," especially for "populations experiencing the greatest disparities and risks in cognitive health."
Significance: Using the Frascati criteria, 52% - 59% of people with HIV experience some form of HIV-Associated Neurocognitive Disorder (HAND) which affects medication adherence, instrumental activities of daily living (IADLs), and even mood maintenance and quality of life. By 2020, 70% of adults with HIV in the United States will be 50 and older; thus, cognitive aging in this group represents a major concern. In a prior study (R03MH076642-01A2) conducted in the HAART era, when comparing cognitive functioning between older and younger HIV-positive and HIV-negative adults, older adults with HIV performed the worst. In the HAART era, these cognitive impairments continue to be observed in several cognitive domains including memory, learning, executive functioning, and speed of processing.
Regrettably, few behavioral interventions aimed at improving cognition in this pharmacologically-burdened population have been attempted. Pharmacological interventions have short-lived effects, if any, and can produce adverse side effects in a population prone to multiple comorbidities. Fortunately, computerized cognitive training interventions have been shown to improve cognition without adverse side-effects. Yet, only two types of computerized cognitive training interventions have been studied in adults with HIV. Becker and colleagues partially randomized 60 adults with HIV and without HIV to engage in 14 computerized targeted modules (e.g., knowledge, memory) over 24 weeks. No significant effects were found; however, adherence was poor. In a prior study, investigators randomized 46 adults to either a speed of processing training (10 hrs of training) group or a no-contact control group. Adherence was excellent and improvements were observed on this cognitive domain which transferred to an everyday functioning task.
Despite this lack of cognitive training studies in HIV, studies in older adults have shown their efficacy in improving specific cognitive abilities, some as much as 1-1.5 standard deviations (SD) above baseline performance or age/education-based norms. Using Frascati criteria, HAND is diagnosed when a person performs at least 1 to 2 SD below their normative mean on measures of two or more cognitive domains (e.g., verbal memory, speed of processing, executive functioning); yet many individuals may be only a fraction of a SD below the cut off. A meta-analysis of 52 cognitive training studies indicated the average cognitive improvement following cognitive training was 0.22 SD. Although this seems to be a small to moderate effect size, such cognitive training programs can change the diagnosis of HAND for some by improving cognitive performance to within acceptable performance norms. In this study, older adults (50+) with HAND will be enrolled to determine which cognitive domains are attributable to their diagnosis. Then those cognitive domains in which they have impairments will be targeted for training with the corresponding cognitive program. Such a tailored approach to standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning and quality of life. This approach also represents a paradigm shift in changing the way clinicians and researchers look at HAND in that this is not a static "progressive" diagnosis; Antinori et al. observed a 20% fluctuation of HAND over as little as 1 year, with some improving or declining in their cognitive performance. Such fluctuations, at least partially, reflect positive neuroplasticity that can be manipulated with cognitive training to improve cognition which can improve medication adherence and other IADLs. This study will use a basic two group pre-post experimental design of 146 adults with HAND.
- Conditions
- HIV-Associated Cognitive Motor Complex, Aging, Cognitive Impairment, Cognitive Decline, Attention Impaired, Processing, Visual Spatial
- Being tested
- Individualized Cognitive Training, No-Contact Control
- Medical subject headings
- AIDS Dementia Complex, Cognitive Dysfunction, Spatial Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Cognitive TrainingBehavioural
Also called Insight Software
These are specific computerized exercises that are designed to improve performance in particular cognitive domains (e.g., attention, speed of processing, verbal learning/memory).
No-Contact ControlOther
Also called Control Group
This is simply a no-contact control group. Participants in this group will receive no additional contact with the study beyond the baseline and posttest assessments.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Cognitive Training | Experimental | Participants randomized to this arm will receive 20 hours of computerized cognitive training in the two predominate cognitive domains in which they experience deficits that contribute to their HIV-Associated Neurocognitive Disorder diagnosis. Receives: Behavioral: Individualized Cognitive Training |
| No-Contact Control | Other | Participants in this arm will not receive any experimental or sham contact. They will only participate in the Baseline and Posttest assessments. Receives: Other: No-Contact Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and Severity of HIV-Associated Neurocognitive Disorder (HAND) as Measured by Neurocognitive Tests Interpreted by the Frascati Criteria
Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. A battery of neurocognitive tests (e.g., Trails Making Test A, Trails Making Test B, etc.) of different domains (e.g., speed of processing, verbal memory, etc.) are used which are normed by age/education which are then use with the Frascati Criteria (a neurological algorithm to classify cognitive impairment) to determine HIV-Associated Neurocognitive Disorder, both presence and severity (i.e., Global Severity Rating). This is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Secondary outcomes (7)
Improvement on Everyday Functioning as Measured by the Timed Instrumental Activities of Daily Living Test
The Timed Instrumental Activities of Daily Living Test -- This test measures the accuracy and time it takes to perform 5 IADLs (e.g., counting out correct change, reading ingredients on a can of food). Slower speed of processing is associated with longer times to complete these tasks, even after adjusting for age, education level, depression, and general health. The time from each of the 5 IADLs is added together to form a composite score. Test-retest reliability is 0.64. This test is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement on Everyday Functioning as Measured by the Medication Adherence Scale
Medication Adherence - This IADL is measured by the Simplified Medication Adherence Questionnaire (as well as virological control). It consists of sixl items that ask about how consistently one takes his/her medications; the items can be summed to form a composite score. This measure is validated with virological outcomes and has good internal consistency (α = 0.75) and inter-observer agreement (88.2%). This questionnaire is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Depression
Centers for Epidemiological Studies - Depression Scale (CES-D) - This depression scale measures how often (not at all - extremely) participants acknowledge 20 verbal symptoms of depression; score are tallied to form a composite score; higher scores indicate greater self-reported depressive symptomatology. Cronbach's α is very good at 0.88. This scale is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Internal Locus of Control
Internal Locus of Control - This six (6-point Likert-type) item measure assesses the degree to which participants perceive that they can exert influence over their life. The items are summed to form a composite score; higher scores indicate more internal locus of control. Cronbach's α's range from 0.62 to 0.79. This measure is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Health-Related Quality of Life
Medical Outcomes Study Short Form (SF-36)/Health-Related Quality of Life - SF-36 assesses health-related quality of life which is a subscale of this measure. The item of this subscale are summed to form a composite score. In the ACTIVE Study, improvement on this variable was observed in the speed of processing training group. Cronbach's α is greater than 0.85. This subscale is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Self-Rated Health
Medical Outcomes Study Short Form (SF-36)/Self-Rated Health - SF-36 assesses self-rated health on only 1 item which is a Likert type scale (In general, I would say that my health is: Excellent, Very Good, Good, Fair, Poor). In the ACTIVE Study, improvement on self-rated health was observed in the speed of processing training group. This item is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Cognitive Complaints
Cognitive Failures Questionnaire (CFQ) - CFQ assesses common everyday cognitive complaints one may have such as in memory (e.g., "Do you forget where you put something like a newspaper or book?"). All of the 25 items on this measure are summed to form an overall composite score; higher scores are indicative of greater subjective cognitive complaints. This questionnaire is administered at baseline and posttest.
Measured: Per participants, approximately 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start27 Jul 2017
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HIV-Associated Cognitive Motor ComplexStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pre-post two-group experimental design will be used.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, David Vance, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122288
- Sponsor's protocol ID
- F161122002
- Other IDs
- 1R21NR016632-01
- Acronym
- TOPS
- Status last verified
- Oct 2021
- First submitted
- 11 Apr 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vance DE, Fazeli PL, Ross LA, Wadley VG, Ball KK. Speed of processing training with middle-age and older adults with HIV: a pilot study. J Assoc Nurses AIDS Care. 2012 Nov-Dec;23(6):500-10. doi: 10.1016/j.jana.2012.01.005. Epub 2012 May 11.
PubMed 22579081Vance DE, Fazeli PL, Moneyham L, Keltner NL, Raper JL. Assessing and treating forgetfulness and cognitive problems in adults with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S40-60. doi: 10.1016/j.jana.2012.03.006.
PubMed 23290376Vance DE. Prevention, Rehabilitation, and Mitigation Strategies of Cognitive Deficits in Aging with HIV: Implications for Practice and Research. ISRN Nurs. 2013;2013:297173. doi: 10.1155/2013/297173. Epub 2013 Feb 3.
PubMed 23431469Lin F, Chen DG, Vance D, Mapstone M. Trajectories of combined laboratory- and real world-based speed of processing in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):364-73. doi: 10.1093/geronb/gbs075. Epub 2012 Sep 11.
PubMed 22967505Fazeli PL, Ross LA, Vance DE, Ball K. The relationship between computer experience and computerized cognitive test performance among older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):337-46. doi: 10.1093/geronb/gbs071. Epub 2012 Aug 28.
PubMed 22929395Kaur J, Dodson JE, Steadman L, Vance DE. Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. J Neurosci Nurs. 2014 Feb;46(1):23-33. doi: 10.1097/JNN.0000000000000034.
PubMed 24399164Byun JY, Azuero A, Fazeli PL, Li W, Chapman Lambert C, Del Bene VA, Triebel K, Jacob A, Vance DE. Perceived Improvement and Satisfaction With Training After Individualized-Targeted Computerized Cognitive Training in Adults With HIV-Associated Neurocognitive Disorder Living in Alabama: A Descriptive Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):581-586. doi: 10.1097/JNC.0000000000000333. Epub 2022 Apr 1. No abstract available.
PubMed 35363623Vance DE, Pope CN, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Byun JY, Ball KK. A Randomized Clinical Trial on the Impact of Individually Targeted Computerized Cognitive Training on Quality of Life Indicators in Adults With HIV-Associated Neurocognitive Disorder in the Southeastern United States. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):295-310. doi: 10.1097/JNC.0000000000000316. Epub 2021 Dec 6.
PubMed 34864757Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.
PubMed 33449578Vance DE, Robinson J, Walker TJ, Tende F, Bradley B, Diehl D, McKie P, Fazeli PL. Reactions to a Probable Diagnosis of HIV-Associated Neurocognitive Disorder: A Content Analysis. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):279-289. doi: 10.1097/JNC.0000000000000120.
PubMed 31436599Vance DE, Cody SL, Nicholson WC, Cheatwood J, Morrison S, Fazeli PL. The Association Between Olfactory Function and Cognition in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e144-e155. doi: 10.1097/JNC.0000000000000086.
PubMed 31259847Vance DE, Lee L, Munoz-Moreno JA, Morrison S, Overton T, Willig A, Fazeli PL. Cognitive Reserve Over the Lifespan: Neurocognitive Implications for Aging With HIV. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e109-e121. doi: 10.1097/JNC.0000000000000071.
PubMed 30865059Vance DE, Cody SL, Nicholson C, Cheatwood J, Morrison S, Fazeli PL. Olfactory Dysfunction in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):e19-e30. doi: 10.1097/JNC.0000000000000061.
PubMed 30676359Vance DE, Fazeli PL, Cheatwood J, Nicholson WC, Morrison SA, Moneyham LD. Computerized Cognitive Training for the Neurocognitive Complications of HIV Infection: A Systematic Review. J Assoc Nurses AIDS Care. 2019 Jan-Feb;30(1):51-72. doi: 10.1097/JNC.0000000000000030.
PubMed 30586083Vance DE, Blake BJ, Brennan-Ing M, DeMarco RF, Fazeli PL, Relf MV. Revisiting Successful Aging With HIV Through a Revised Biopsychosocial Model: An Update of the Literature. J Assoc Nurses AIDS Care. 2019 Jan-Feb;30(1):5-14. doi: 10.1097/JNC.0000000000000029.
PubMed 30586079
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized-Targeted Cognitive Training in Older Adults With HAND
- ClinicalTrials.gov ID
- NCT03122288
- Acronym / sponsor ID
- TOPS / F161122002
- Conditions
- HIV-Associated Cognitive Motor Complex, Aging, Cognitive Impairment, Cognitive Decline, Attention Impaired, Processing, Visual Spatial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular disease, hypertension, and insulin resistance which will further contribute to poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed when a person performs less than 1 to 2 SD below their normative mean (education \& age) on measures of two or more cognitive domains (e.g., attention, speed of processing, verbal memory, executive functioning). Yet, from the cognitive literature and prior studies, administering certain computerized cognitive training programs may improve specific cognitive domains in older adults and those with HIV. Such cognitive training programs may be effective in older adults with HIV and therefore investigators may be able to change the diagnosis of HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted Cognitive Training, or 2) a no-contact control group. The investigators will focus on those cognitive domains in which participants express an impairment and train them with the corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach using standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare adults who do receive individualized-targeted cognitive training to those who do not in order to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2: Determine whether improvements in HAND and/or everyday functioning over time mediate improvements in quality of life.
Detailed description
This research directly meets the goals of the NIH Cognitive and Emotional Health Project and the Healthy Brain Initiative which seek to "maintain or improve the cognitive performance of all adults," especially for "populations experiencing the greatest disparities and risks in cognitive health."
Significance: Using the Frascati criteria, 52% - 59% of people with HIV experience some form of HIV-Associated Neurocognitive Disorder (HAND) which affects medication adherence, instrumental activities of daily living (IADLs), and even mood maintenance and quality of life. By 2020, 70% of adults with HIV in the United States will be 50 and older; thus, cognitive aging in this group represents a major concern. In a prior study (R03MH076642-01A2) conducted in the HAART era, when comparing cognitive functioning between older and younger HIV-positive and HIV-negative adults, older adults with HIV performed the worst. In the HAART era, these cognitive impairments continue to be observed in several cognitive domains including memory, learning, executive functioning, and speed of processing.
Regrettably, few behavioral interventions aimed at improving cognition in this pharmacologically-burdened population have been attempted. Pharmacological interventions have short-lived effects, if any, and can produce adverse side effects in a population prone to multiple comorbidities. Fortunately, computerized cognitive training interventions have been shown to improve cognition without adverse side-effects. Yet, only two types of computerized cognitive training interventions have been studied in adults with HIV. Becker and colleagues partially randomized 60 adults with HIV and without HIV to engage in 14 computerized targeted modules (e.g., knowledge, memory) over 24 weeks. No significant effects were found; however, adherence was poor. In a prior study, investigators randomized 46 adults to either a speed of processing training (10 hrs of training) group or a no-contact control group. Adherence was excellent and improvements were observed on this cognitive domain which transferred to an everyday functioning task.
Despite this lack of cognitive training studies in HIV, studies in older adults have shown their efficacy in improving specific cognitive abilities, some as much as 1-1.5 standard deviations (SD) above baseline performance or age/education-based norms. Using Frascati criteria, HAND is diagnosed when a person performs at least 1 to 2 SD below their normative mean on measures of two or more cognitive domains (e.g., verbal memory, speed of processing, executive functioning); yet many individuals may be only a fraction of a SD below the cut off. A meta-analysis of 52 cognitive training studies indicated the average cognitive improvement following cognitive training was 0.22 SD. Although this seems to be a small to moderate effect size, such cognitive training programs can change the diagnosis of HAND for some by improving cognitive performance to within acceptable performance norms. In this study, older adults (50+) with HAND will be enrolled to determine which cognitive domains are attributable to their diagnosis. Then those cognitive domains in which they have impairments will be targeted for training with the corresponding cognitive program. Such a tailored approach to standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning and quality of life. This approach also represents a paradigm shift in changing the way clinicians and researchers look at HAND in that this is not a static "progressive" diagnosis; Antinori et al. observed a 20% fluctuation of HAND over as little as 1 year, with some improving or declining in their cognitive performance. Such fluctuations, at least partially, reflect positive neuroplasticity that can be manipulated with cognitive training to improve cognition which can improve medication adherence and other IADLs. This study will use a basic two group pre-post experimental design of 146 adults with HAND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre-post two-group experimental design will be used.
| Arm | Type | Receives |
|---|---|---|
| Individualized Cognitive Training | Experimental | Behavioral: Individualized Cognitive TrainingParticipants randomized to this arm will receive 20 hours of computerized cognitive training in the two predominate cognitive domains in which they experience deficits that contribute to their HIV-Associated Neurocognitive Disorder diagnosis. |
| No-Contact Control | Other | Other: No-Contact ControlParticipants in this arm will not receive any experimental or sham contact. They will only participate in the Baseline and Posttest assessments. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 40+ years
- English speaking
- Have HIV-Associated Neurocognitive Disorder (HAND)
Key exclusion criteria (5 listed)
- Because the study requires several weeks, participants not living in stable housing (e.g., halfway house) will be excluded.
- Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
- Currently undergoing radiation or chemotherapy
- A history of brain trauma with a loss of consciousness greater than 30 minutes
- Legally blind or deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Cognitive TrainingAlso: Insight SoftwareThese are specific computerized exercises that are designed to improve performance in particular cognitive domains (e.g., attention, speed of processing, verbal learning/memory). | Behavioural | Individualized Cognitive Training |
| No-Contact ControlAlso: Control GroupThis is simply a no-contact control group. Participants in this group will receive no additional contact with the study beyond the baseline and posttest assessments. | Other | No-Contact Control |
Primary outcome
Prevalence and Severity of HIV-Associated Neurocognitive Disorder (HAND) as Measured by Neurocognitive Tests Interpreted by the Frascati Criteria
Time frame: Per participants, approximately 10-12 weeks
Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. A battery of neurocognitive tests (e.g., Trails Making Test A, Trails Making Test B, etc.) of different domains (e.g., speed of processing, verbal memory, etc.) are used which are normed by age/education which are then use with the Frascati Criteria (a neurological algorithm to classify cognitive impairment) to determine HIV-Associated Neurocognitive Disorder, both presence and severity (i.e., Global Severity Rating). This is administered at baseline and posttest.
7 secondary outcomes
Improvement on Everyday Functioning as Measured by the Timed Instrumental Activities of Daily Living Test
Time frame: Per participants, approximately 10-12 weeks
Improvement on Everyday Functioning as Measured by the Medication Adherence Scale
Time frame: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Depression
Time frame: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Internal Locus of Control
Time frame: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Health-Related Quality of Life
Time frame: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Self-Rated Health
Time frame: Per participants, approximately 10-12 weeks
Improvement in Quality of Life as Measured by Cognitive Complaints
Time frame: Per participants, approximately 10-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 22579081Vance DE, Fazeli PL, Ross LA, Wadley VG, Ball KK. Speed of processing training with middle-age and older adults with HIV: a pilot study. J Assoc Nurses AIDS Care. 2012 Nov-Dec;23(6):500-10. doi: 10.1016/j.jana.2012.01.005. Epub 2012 May 11.
- Background: PubMed 23290376Vance DE, Fazeli PL, Moneyham L, Keltner NL, Raper JL. Assessing and treating forgetfulness and cognitive problems in adults with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S40-60. doi: 10.1016/j.jana.2012.03.006.
- Background: PubMed 23431469Vance DE. Prevention, Rehabilitation, and Mitigation Strategies of Cognitive Deficits in Aging with HIV: Implications for Practice and Research. ISRN Nurs. 2013;2013:297173. doi: 10.1155/2013/297173. Epub 2013 Feb 3.
- Background: PubMed 22967505Lin F, Chen DG, Vance D, Mapstone M. Trajectories of combined laboratory- and real world-based speed of processing in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):364-73. doi: 10.1093/geronb/gbs075. Epub 2012 Sep 11.
- Background: PubMed 22929395Fazeli PL, Ross LA, Vance DE, Ball K. The relationship between computer experience and computerized cognitive test performance among older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):337-46. doi: 10.1093/geronb/gbs071. Epub 2012 Aug 28.
- Background: PubMed 24399164Kaur J, Dodson JE, Steadman L, Vance DE. Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. J Neurosci Nurs. 2014 Feb;46(1):23-33. doi: 10.1097/JNN.0000000000000034.
- Derived from this study: PubMed 35363623Byun JY, Azuero A, Fazeli PL, Li W, Chapman Lambert C, Del Bene VA, Triebel K, Jacob A, Vance DE. Perceived Improvement and Satisfaction With Training After Individualized-Targeted Computerized Cognitive Training in Adults With HIV-Associated Neurocognitive Disorder Living in Alabama: A Descriptive Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):581-586. doi: 10.1097/JNC.0000000000000333. Epub 2022 Apr 1. No abstract available.
- Derived from this study: PubMed 34864757Vance DE, Pope CN, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Byun JY, Ball KK. A Randomized Clinical Trial on the Impact of Individually Targeted Computerized Cognitive Training on Quality of Life Indicators in Adults With HIV-Associated Neurocognitive Disorder in the Southeastern United States. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):295-310. doi: 10.1097/JNC.0000000000000316. Epub 2021 Dec 6.
- Derived from this study: PubMed 33449578Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.
- Derived from this study: PubMed 31436599Vance DE, Robinson J, Walker TJ, Tende F, Bradley B, Diehl D, McKie P, Fazeli PL. Reactions to a Probable Diagnosis of HIV-Associated Neurocognitive Disorder: A Content Analysis. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):279-289. doi: 10.1097/JNC.0000000000000120.
- Derived from this study: PubMed 31259847Vance DE, Cody SL, Nicholson WC, Cheatwood J, Morrison S, Fazeli PL. The Association Between Olfactory Function and Cognition in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e144-e155. doi: 10.1097/JNC.0000000000000086.
- Derived from this study: PubMed 30865059Vance DE, Lee L, Munoz-Moreno JA, Morrison S, Overton T, Willig A, Fazeli PL. Cognitive Reserve Over the Lifespan: Neurocognitive Implications for Aging With HIV. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e109-e121. doi: 10.1097/JNC.0000000000000071.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Cognitive Training in people with HIV-Associated Cognitive Motor Complex and Aging, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Severity of HIV-Associated Neurocognitive Disorder (HAND) as Measured by Neurocognitive Tests Interpreted by the Frascati Criteria (time frame: Per participants, approximately 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122288, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.