HIVSOPNCT02758093
Speed of Processing Training in Adults With HIV
A study testing Speed of Processing Training and Internet Navigational in people with HIV and Cognition - Other, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV, Cognition - Other, Impaired Driving
- What is being tested?
- Speed of Processing Training and Internet Navigational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 11 Mar 2020
- 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
- Since driving-related factors are being examined as one of the outcomes of the intervention, participants must be licensed drivers when entering the study.
- Men and/or women
- Must be 40+ years
- English speaking
- Have HIV-Associated Neurocognitive Disorder (HAND) or borderline HAND (defined using Frascati criteria).
Who cannot join
- Because this study is longitudinal, participants not living in stable housing (e.g., halfway house) will be excluded.
- Potential participants will be excluded if they indicate that they are planning to move outside of the Birmingham metropolitan area within the next 2 years.
- Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
- Legally blind or deaf (vision confirmed at baseline)
- Currently undergoing radiation or chemotherapy
- A history of brain trauma with a loss of consciousness greater than 30 minutes
- Those who have participated in our pilot studies and were randomized to the Speed of Processing Training will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: An RCT of Speed of Processing Training in Middle-Aged and Older Adults With HIV
As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Although interventions are needed to protect/improve cognitive functioning, one intervention already exists to improve speed of processing. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N = 2,802 community-dwelling older adults) has the ability to enable "older people to maintain their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE Study, this intervention uniquely improves driving, instrumental activities of daily living (IADL), health-related quality of life, self-rated health, internal locus of control, and protects one from depression; these represent areas of needed intervention for adults with HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing declines are associated with poorer driving simulator performance and more self-reported at-fault automobile crashes; such speed of processing declines on driving alone represent a significant public health concern. These studies also demonstrated that Speed of Processing Training improved this cognitive ability and translated into improved performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized computer-contact control (sham) condition.
AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this cognitive ability at post-test, year 1, and year 2 after baseline.
Read more
AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday functioning at post-test, year 1, and year 2 after baseline.
Exploratory AIM: Determine whether improvement in speed in speed of processing and/or everyday functioning over time mediate improvement quality of life (e.g., depression, health related quality of life).
Read the detailed description
SPECIFIC AIMS
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 Fascati criteria, 52% - 59% of people with HIV experience HIV-associated Neurocognitive Disorder (HAND) which affects driving safety, medication adherence, and instrumental activities of daily living (IADLs). Cognitive aging in this group represents a major concern since by 2020, 70% of adults with HIV in the United States will be 50 and older. Thus, there is a growing population that is particularly vulnerable to HAND due to the co-occurrence with aging-related cognitive impairments. In our 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, reasoning/executive functioning, and one area of particular importance - speed of processing.
Speed of processing is the rate at which cognitive functions are performed. People with HIV are vulnerable to speed of processing declines, especially as they age. Such speed of processing declines are associated with poorer driving performance, and more at-fault crashes in normal older adults, as well as middle-aged (40+) and older adults with HIV, which is a growing public health concern. In the Southern U.S., specifically in the Deep South where this study will occur, these points are highly relevant because: 1) even with speed of processing declines, adults with HIV must rely on their own driving, especially in rural areas with limited public transportation; and 2) the epicenter of HIV has emerged here in the last decade, which means many lower SES adults and/or African Americans with HIV will also have HAND or borderline HAND. Regrettably, few behavioral interventions have tried to improve cognition in this pharmacologically-burdened population; and pharmacological cognitive interventions produce adverse side effects in a population already experiencing multiple comorbidities. Fortunately, some types of computerized cognitive interventions have been shown to improve cognition without adverse side-effects. Yet, only two types of computerized cognitive interventions have been conducted in adults with HIV, with one being Speed of Processing Training.
Specific Aim 1: Determine whether 10 vs 20 hours of Speed of Processing Training will improve this cognitive ability at post-test, year 1, and year 2 after baseline. Hypothesis 1- Adults with HAND or borderline HAND will have improved speed of processing over time as they engage in more hours of training compared to those in the contact control (sham) condition.
Specific Aim 2: Determine whether 10 vs 20 hours of Speed of Processing Training will improve everyday functioning at post-test, year 1, and year 2 after baseline. Hypothesis 2- Adults with HAND or borderline HAND will have improved everyday functioning (e.g., IADLs, driving, medication adherence) over time as they engage in more hours of training compared to those in the contact control (sham) condition.
Exploratory Aim: Determine whether improvement in speed of processing and/or everyday functioning over time mediate improvement in quality of life (e.g., depression, locus of control, health-related quality of life).
Innovation: We are the first to develop Speed of Processing Training and use it with older adults and those with HIV. This non-pharmacological intervention improves the rate at which normal, community-dwelling older adults process information and has been shown to improve performance in driving, IADLs, and health-related quality of life several years after training. In prior studies, we demonstrated that after only 10 hours of Speed of Processing Training, this inexpensive intervention significantly improved speed of processing and IADLs in adults with HIV in the short-term. As part of the ACTIVE Study (N = 2,802), three types of cognitive training in 6 sites across the U.S. were compared: speed of processing, memory, and reasoning. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study enabled "older people to maintain their cognitive abilities as they age," even 10 years after training. The ACTIVE Study also examined reasoning and memory training; however, Speed of Processing Training was uniquely found also to enhance tertiary outcomes: (1) protect against depression and (2) improve self-rated health, internal locus of control, and health-related quality of life. These tertiary/quality of life outcomes are essential areas in HIV that likewise require intervention. This RCT of 264 adults with HAND or borderline HAND will extend the ability to demonstrate that we cannot only improve speed of processing and everyday functioning in the short-term, but over a 2-year period.
- Conditions
- HIV, Cognition - Other, Impaired Driving
- Being tested
- Speed of Processing Training, Internet Navigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed of Processing TrainingBehavioural
Also called Insight Software
These are specific computerized exercises that are designed to increase the rate in which people can process visual information.
Internet NavigationalOther
Also called Contact Control Condition
This is a sham condition in which participants will receive the same amount of social and computer contact as those randomized to receive the 10 hours of speed of processing training. In this condition, participants will learn how to do various activities on the internet.
| Study group | Role | What they receive |
|---|---|---|
| Speed of Processing Training (10 hours) | Experimental | Participants randomized to this arm will receive 10 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). Receives: Behavioral: Speed of Processing Training |
| Speed of Processing Training (20 hours) | Experimental | Participants randomized to this arm will receive 20 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). Receives: Behavioral: Speed of Processing Training |
| Internet Navigational (10 hours) | Sham comparator | In this group, participants will receive 10 hours of Internet Navigation Training. Specifically, participants will be given instructional materials and exercises on how to navigate the Internet. For more computer savvy participants, they will be directed to the Thinks.com website. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). Receives: Other: Internet Navigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Speed of Processing Measures at baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Measured: at baseline
Mean Speed of Processing Measures at 10 - 12 weeks after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Measured: at 10-12 weeks after baseline
Mean Speed of Processing Measures at 1 year after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Measured: at 1 year after baseline
Mean Speed of Processing Measures at 2 years after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Measured: at 2 years after baseline
Secondary outcomes (7)
Driving Simulation (a measure of everyday functioning)
This driving simulator generates several outcome variables including number of crashes, number of pedestrians hit, gross reaction time, and other related driving outcomes data.
Measured: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Number of vehicular crashes identified in State Crash Records for the 5 years prior to enrollment
Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles.
Measured: from baseline to 5 years prior to baseline
Driving Habits Questionnaire (a measure of everyday functioning)
This questionnaire measures self-reported data on the participants' perceived ability to drive.
Measured: from baseline to 5 years prior to baseline
Timed Instrument Activities of Daily Living (a measure of everyday functioning)
This test measures the time required and the accuracy in which 5 instrumental activities of daily living (e.g., counting change) are done.
Measured: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Medication Adherence (a measure of everyday functioning)
This is a questionnaire that assesses how well participants take their medication as prescribed.
Measured: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Number of vehicular crashes identified in State Crash Records at 2.5 years after enrollment
Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles.
Measured: from baseline to 2.5 years after baseline
Number of vehicular crashes identified in State Crash Records at 5 years after enrollment
Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles.
Measured: from baseline to 5 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start28 Sep 2016
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Vance, PhD, University of Alabama at Birmingham
- Investigators
- David E Vance, PhD, Principal investigator, University of Alabama at Birmingham, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758093
- Sponsor's protocol ID
- F160122002
- Acronym
- SOP
- Status last verified
- Jun 2021
- First submitted
- 21 Mar 2016
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will make the cleaned electronic database available to NIMH after the study is complete.
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 24399164Domoyeri P, Aroke EN, Freij KW, Vickers JK, Vance DE, Fazeli PL. Sleep Quality and Depressive Symptoms Mediate the Relationship Between Pain and Everyday Function: A Cross-Sectional Study of Adults Living With HIV in Birmingham, Alabama. J Assoc Nurses AIDS Care. 2026 Sep 3. doi: 10.1097/JNC.0000000000000677. Online ahead of print.
PubMed 42689866Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Jacob A, Ball KK. A 2-Year, Randomized, Clinical Trial Examining the Effects of Speed of Processing Cognitive Training on Quality-of-Life Indicators in Adults With HIV-Associated Neurocognitive Disorder in Birmingham, Alabama: Results of the Think Fast Study. J Assoc Nurses AIDS Care. 2024 Mar-Apr 01;35(2):104-121. doi: 10.1097/JNC.0000000000000449. Epub 2024 Jan 18.
PubMed 38949906Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Ball KK. A 2-year longitudinal randomized controlled trial examining the transfer of speed of processing training to secondary cognitive domains in middle-aged and older adults with HIV-associated neurocognitive disorder: Results of the think fast study. Clin Neuropsychol. 2024 Feb;38(2):471-492. doi: 10.1080/13854046.2023.2212867. Epub 2023 May 16.
PubMed 37191339Waldrop 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 30586083
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of Speed of Processing Training in Middle-Aged and Older Adults With HIV
- ClinicalTrials.gov ID
- NCT02758093
- Acronym / sponsor ID
- SOP / F160122002
- Conditions
- HIV, Cognition - Other, Impaired Driving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Although interventions are needed to protect/improve cognitive functioning, one intervention already exists to improve speed of processing. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N = 2,802 community-dwelling older adults) has the ability to enable "older people to maintain their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE Study, this intervention uniquely improves driving, instrumental activities of daily living (IADL), health-related quality of life, self-rated health, internal locus of control, and protects one from depression; these represent areas of needed intervention for adults with HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing declines are associated with poorer driving simulator performance and more self-reported at-fault automobile crashes; such speed of processing declines on driving alone represent a significant public health concern. These studies also demonstrated that Speed of Processing Training improved this cognitive ability and translated into improved performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized computer-contact control (sham) condition.
AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this cognitive ability at post-test, year 1, and year 2 after baseline.
AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday functioning at post-test, year 1, and year 2 after baseline.
Exploratory AIM: Determine whether improvement in speed in speed of processing and/or everyday functioning over time mediate improvement quality of life (e.g., depression, health related quality of life).
Detailed description
SPECIFIC AIMS
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 Fascati criteria, 52% - 59% of people with HIV experience HIV-associated Neurocognitive Disorder (HAND) which affects driving safety, medication adherence, and instrumental activities of daily living (IADLs). Cognitive aging in this group represents a major concern since by 2020, 70% of adults with HIV in the United States will be 50 and older. Thus, there is a growing population that is particularly vulnerable to HAND due to the co-occurrence with aging-related cognitive impairments. In our 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, reasoning/executive functioning, and one area of particular importance - speed of processing.
Speed of processing is the rate at which cognitive functions are performed. People with HIV are vulnerable to speed of processing declines, especially as they age. Such speed of processing declines are associated with poorer driving performance, and more at-fault crashes in normal older adults, as well as middle-aged (40+) and older adults with HIV, which is a growing public health concern. In the Southern U.S., specifically in the Deep South where this study will occur, these points are highly relevant because: 1) even with speed of processing declines, adults with HIV must rely on their own driving, especially in rural areas with limited public transportation; and 2) the epicenter of HIV has emerged here in the last decade, which means many lower SES adults and/or African Americans with HIV will also have HAND or borderline HAND. Regrettably, few behavioral interventions have tried to improve cognition in this pharmacologically-burdened population; and pharmacological cognitive interventions produce adverse side effects in a population already experiencing multiple comorbidities. Fortunately, some types of computerized cognitive interventions have been shown to improve cognition without adverse side-effects. Yet, only two types of computerized cognitive interventions have been conducted in adults with HIV, with one being Speed of Processing Training.
Specific Aim 1: Determine whether 10 vs 20 hours of Speed of Processing Training will improve this cognitive ability at post-test, year 1, and year 2 after baseline. Hypothesis 1- Adults with HAND or borderline HAND will have improved speed of processing over time as they engage in more hours of training compared to those in the contact control (sham) condition.
Specific Aim 2: Determine whether 10 vs 20 hours of Speed of Processing Training will improve everyday functioning at post-test, year 1, and year 2 after baseline. Hypothesis 2- Adults with HAND or borderline HAND will have improved everyday functioning (e.g., IADLs, driving, medication adherence) over time as they engage in more hours of training compared to those in the contact control (sham) condition.
Exploratory Aim: Determine whether improvement in speed of processing and/or everyday functioning over time mediate improvement in quality of life (e.g., depression, locus of control, health-related quality of life).
Innovation: We are the first to develop Speed of Processing Training and use it with older adults and those with HIV. This non-pharmacological intervention improves the rate at which normal, community-dwelling older adults process information and has been shown to improve performance in driving, IADLs, and health-related quality of life several years after training. In prior studies, we demonstrated that after only 10 hours of Speed of Processing Training, this inexpensive intervention significantly improved speed of processing and IADLs in adults with HIV in the short-term. As part of the ACTIVE Study (N = 2,802), three types of cognitive training in 6 sites across the U.S. were compared: speed of processing, memory, and reasoning. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study enabled "older people to maintain their cognitive abilities as they age," even 10 years after training. The ACTIVE Study also examined reasoning and memory training; however, Speed of Processing Training was uniquely found also to enhance tertiary outcomes: (1) protect against depression and (2) improve self-rated health, internal locus of control, and health-related quality of life. These tertiary/quality of life outcomes are essential areas in HIV that likewise require intervention. This RCT of 264 adults with HAND or borderline HAND will extend the ability to demonstrate that we cannot only improve speed of processing and everyday functioning in the short-term, but over a 2-year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Speed of Processing Training (10 hours) | Experimental | Behavioral: Speed of Processing TrainingParticipants randomized to this arm will receive 10 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). |
| Speed of Processing Training (20 hours) | Experimental | Behavioral: Speed of Processing TrainingParticipants randomized to this arm will receive 20 hours of speed of processing training; this training is designed to improve the speed/accuracy in which they identify and locate visual information using five games/exercises from the POSIT Science Speed of Processing Training. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). |
| Internet Navigational (10 hours) | Sham comparator | Other: Internet NavigationalIn this group, participants will receive 10 hours of Internet Navigation Training. Specifically, participants will be given instructional materials and exercises on how to navigate the Internet. For more computer savvy participants, they will be directed to the Thinks.com website. Those who receive 20 hours of speed of processing training will be compared to those participants who are randomized only to receive 10 hours speed of processing training; both of these groups will be compared to those randomized to receive only 10 hours of a computer training (Contact Control Group). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Since driving-related factors are being examined as one of the outcomes of the intervention, participants must be licensed drivers when entering the study.
- Men and/or women
- Must be 40+ years
- English speaking
- Have HIV-Associated Neurocognitive Disorder (HAND) or borderline HAND (defined using Frascati criteria).
Key exclusion criteria (7 listed)
- Because this study is longitudinal, participants not living in stable housing (e.g., halfway house) will be excluded.
- Potential participants will be excluded if they indicate that they are planning to move outside of the Birmingham metropolitan area within the next 2 years.
- Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
- Legally blind or deaf (vision confirmed at baseline)
- Currently undergoing radiation or chemotherapy
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 |
|---|---|---|
| Speed of Processing TrainingAlso: Insight SoftwareThese are specific computerized exercises that are designed to increase the rate in which people can process visual information. | Behavioural | Speed of Processing Training (10 hours), Speed of Processing Training (20 hours) |
| Internet NavigationalAlso: Contact Control ConditionThis is a sham condition in which participants will receive the same amount of social and computer contact as those randomized to receive the 10 hours of speed of processing training. In this condition, participants will learn how to do various activities on the internet. | Other | Internet Navigational (10 hours) |
Primary outcome
Mean Speed of Processing Measures at baseline
Time frame: at baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Mean Speed of Processing Measures at 10 - 12 weeks after baseline
Time frame: at 10-12 weeks after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Mean Speed of Processing Measures at 1 year after baseline
Time frame: at 1 year after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
Mean Speed of Processing Measures at 2 years after baseline
Time frame: at 2 years after baseline
Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective.
7 secondary outcomes
Driving Simulation (a measure of everyday functioning)
Time frame: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Number of vehicular crashes identified in State Crash Records for the 5 years prior to enrollment
Time frame: from baseline to 5 years prior to baseline
Driving Habits Questionnaire (a measure of everyday functioning)
Time frame: from baseline to 5 years prior to baseline
Timed Instrument Activities of Daily Living (a measure of everyday functioning)
Time frame: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Medication Adherence (a measure of everyday functioning)
Time frame: Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline)
Number of vehicular crashes identified in State Crash Records at 2.5 years after enrollment
Time frame: from baseline to 2.5 years after baseline
Number of vehicular crashes identified in State Crash Records at 5 years after enrollment
Time frame: from baseline to 5 years after baseline
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 7 Jun 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 42689866Domoyeri P, Aroke EN, Freij KW, Vickers JK, Vance DE, Fazeli PL. Sleep Quality and Depressive Symptoms Mediate the Relationship Between Pain and Everyday Function: A Cross-Sectional Study of Adults Living With HIV in Birmingham, Alabama. J Assoc Nurses AIDS Care. 2026 Sep 3. doi: 10.1097/JNC.0000000000000677. Online ahead of print.
- Derived from this study: PubMed 38949906Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Jacob A, Ball KK. A 2-Year, Randomized, Clinical Trial Examining the Effects of Speed of Processing Cognitive Training on Quality-of-Life Indicators in Adults With HIV-Associated Neurocognitive Disorder in Birmingham, Alabama: Results of the Think Fast Study. J Assoc Nurses AIDS Care. 2024 Mar-Apr 01;35(2):104-121. doi: 10.1097/JNC.0000000000000449. Epub 2024 Jan 18.
- Derived from this study: PubMed 37191339Vance DE, Fazeli PL, Azuero A, Frank JS, Wadley VG, Raper JL, Pope CN, Ball KK. A 2-year longitudinal randomized controlled trial examining the transfer of speed of processing training to secondary cognitive domains in middle-aged and older adults with HIV-associated neurocognitive disorder: Results of the think fast study. Clin Neuropsychol. 2024 Feb;38(2):471-492. doi: 10.1080/13854046.2023.2212867. Epub 2023 May 16.
- 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.
- Individual participant dataSharing planned: Yes. We will make the cleaned electronic database available to NIMH after the study is complete.
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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.
David E Vance, PhD principal investigator
University of Alabama at Birmingham, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of Processing Training and Internet Navigational in people with HIV and Cognition - Other, 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 5 inclusion and 7 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 7 Jun 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. Some participants in this study may receive a placebo. 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?
Mean Speed of Processing Measures at baseline (time frame: at baseline). The study lists 4 primary outcomes in all. 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 NCT02758093, which also lists 19 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 7 Jun 2021.