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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21AG077957-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Cognitive aging in people with HIV (PWH) is of increasing concern for several reasons: 1) between 52%-59% of PWH experience cognitive impairment known as HIV-Associated Neurocognitive Disorder (HAND) which impacts everyday functioning and quality of life; 2) HAND increases in severity and prevalence with age; and 3) 70% of PWH in the United States will be 50 and older by 2030. Fortunately, cognitive training programs can individually target specific cognitive impairments in PWH and possibly reduce the severity and prevalence of HAND and improve everyday functioning and quality of life. This approach is based around the underlying concept of intra-individual variability as controlled through higher level allocation of cognitive resources, known as executive functioning. This feasibility study will use a two-group pre-post experimental design of adults with HAND including: 1) a 20-hours of Executive Functioning Training group (enroll 60, n=48 with attrition), and 2) a no-contact control (enroll 60, n=48 with attrition). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention (i.e., attrition, feedback). Exploratory Aim 1 - Cognition: Compare adults who receive Executive Functioning Training to those who receive no training to determine whether they improve in global cognitive ability and overall cognitive IIV. This high impact study is innovative in the following ways: 1) This is the first study aimed to reduce cognitive IIV in PWH. 2) This is the first study to use IIV as a guide to target solely executive functioning training to improve global cognitive ability, which may reduce the severity and prevalence of HAND. 3) Over the last decade, the epicenter of HIV has emerged in the Deep South where this study will occur. Most participants in this study will be older PWH who identify as lower social economic status (SES) and/or African Americans and experience HAND symptoms.
OVERALL -- A pre-post three-group experimental design will be used. Participants will be recruited from the University of Alabama at Birmingham (UAB) 1917 HIV/AIDS Clinic which has a patient population of +3,600 and is the largest HIV medical provider within 100 miles. Eligible participants will be consented at the UAB Center for Research on Applied Gerontology where a ~2 hr baseline assessment will be administered. Participants' neuropsychological data gathered at baseline will be examined to determine a HAND classification. Only participants with HIV-Associated Neurocognitive Disorder (HAND) will be invited to continue with the study. Stratified random assignment will ensure an equal number of participants in each group by gender, minority status, and with/without executive functioning impairment (i.e., 1 standard deviation below normative mean). After training, participants will complete a posttest assessment.
Recruitment/Retention Strategies. As effective in our studies, recruitment/retention strategies will be used. 1) Recruitment materials distributed in the UAB 1917 HIV/AIDS Clinic. 2) Reminder letters and telephone calls will be used before the scheduled visit. 3) Beverages/snacks will be provided (from departmental funds). 5) Secondary contact information will be collected to follow up with lost participants.
Intervention Protocol BrainHQ (POSIT Science Inc.) cognitive training modules will be used as in our other studies; these programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. The intervention will be administered in the research lab of the UAB Center for Applied Gerontology where many of our other studies have been conducted. Working with BrainHQ, when logging on, participants can only receive the individualized cognitive training exercises they are assigned.
Executive Functioning Training Group. Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the Training On Purpose Study (TOPS), the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect.
No-Contact Control Group. This group will receive no intervention. As this is a pilot/feasibility study, investigators do not have the resources to provide a contact control group. Importantly, in a prior study, investigators established that a no-contact control group and a contact control (sham) group did not significantly differ from each other and both served as an excellent comparison to a cognitive intervention.
Instruments Administration time of the assessment will be ~2 hrs. Investigators will use REDCap and BrainBaseline Assessment of Cognition and Everyday Functioning (BRACE+) tablet for administration of the instruments below to reduce tester burden, tester error, and improve the efficiency of data entry and data management, which will save significant staff time and resources. Other cognitive studies as observed in the HIV Neurobehavioral Research Center (HNRC) group employ testing assessments of similar length. BRACE+ was develop in conjunction with HNRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Executive Functioning Training | Experimental | BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. |
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| No-Contact Control Group | No Intervention | These participants will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Executive Functioning Training | Behavioral | Those in the Executive Functioning Training Group will engage in exercises requiring one to set shift; that is, to maintain at least two sets of rules and decide which is appropriate to determine the response. In using these training exercises in the TOPS study, the effects size was quite large (d=-0.89). Dosage of 20 hours of training is considered an upper range on how much training is needed to produce an optimal therapeutic effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Perceived Need for Cognitive Training | Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely). | ~12 weeks |
| Cognitive Training Satisfaction | Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely). | ~12 weeks |
| Cognitive Training Preferences | Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group. | ~12 weeks |
| Hours of Cognitive Training Completed | Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%). | From enrollment through completion on average around 12 weeks |
| Attrition Rates (After Study Data Collection) | Investigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study. | From enrollment through completion on average around 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Inconsistency (Cognitive Intra-individual Variability) | Cognitive Inconsistency (a type of cognitive intra-individual variability) was calculated with Variability (measures consistency of participants hit reaction times during the test) and Hit Rate Standard Deviation (measures consistency of response speed). These are measured in T scores; 50 indicates a population mean with a standard deviation of 10. Higher T scores indicate more inconsistency, which is considered a poorer cognitive indicator. There is no clinically relevant threshold. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33733311 | Background | Vance DE, Fazeli PL, Azuero A, Wadley VG, Raper JL, Ball KK. Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS). AIDS Behav. 2021 Dec;25(12):3898-3908. doi: 10.1007/s10461-021-03230-y. Epub 2021 Mar 18. | |
| 30710223 | Background | Vance DE, Fazeli PL, Cheatwood J, Nicholson C, Morrison S, Moneyham LD. Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Curr Top Behav Neurosci. 2021;50:503-515. doi: 10.1007/7854_2018_80. |
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We will archive all data electronically without PHI which will be available upon request.
Upon completion of the study
Based upon IRB approval and Data Use Agreement.
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Participants were recruited from our university HIV/AIDS clinic. They were screened over the phone to ascertain if they met some basic entry criteria (i.e., had HIV, living within 60 miles from the center, not homeless, no significant neuromedical comorbidities, not legally blind/deaf, not currently undergoing radiation or chemotherapy, no history of severe head trauma). Participants were compensated for their time. Recruitment occurred from 6/14/2023 to 2/14/2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-Contact Control Group | These participants will not receive any intervention. |
| FG001 | Executive Functioning Training | BrainHQ (POSIT Science Inc.) computerized cognitive training modules were used as in our other studies; but these focused on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Executive Functioning Training | BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is measures in years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-Perceived Need for Cognitive Training | Participants rated whether they need computerize cognitive training to improve their cognition (scale from 0=not at all to 10=extremely). | Posted | Mean | Full Range | score on a scale | ~12 weeks |
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From enrollment until end of follow up, an average of 12 weeks
This study did cognitive training on a computer. Participants also received questionnaires and cognitive testing. This was a low-risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No-Contact Control Group | These participants will not receive any intervention. They only receive cognitive testing and questionnaires. |
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The analysis presented here is a strict intent to treat analysis. Dosage (i.e., amount of actual cognitive training that was delivered) may impact the findings. This is a large data set that is nuanced; we will continue to mine these data to examine for other patterns related to the feasibility and cognitive outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Vance, PhD, University Professor | University of Alabama at Birmingham | 205-934-7589 | devance@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2022 | Apr 7, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2022 | Apr 7, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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A pre-post two-group experimental design will be used. One group will receive the experimental executive functioning training and the other group will not receive anything (no-contact control group)
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| ~12 weeks |
| 33449578 | Background | Waldrop 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. |
| BG001 | No-Contact Control Group | These participants will not receive any intervention. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
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| Sex: Female, Male | Sex is measures as assigned at birth. | Count of Participants | Participants |
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| Race (NIH/OMB) | Race is measures as identified by the participant. | Count of Participants | Participants |
|
| Baseline Assessment of Cognitive Training | How much do you think you need cognitive training to improve your mental abilities? (1=not at all; 10=definitely need) | Mean | Standard Deviation | score on a scale |
|
| OG001 | No-Contact Control Group | These participants will not receive any intervention. |
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| Primary | Cognitive Training Satisfaction | Participants were asked how much they enjoyed the cognitive training (scale from 1=not at all to 5=extremely). | This question was not asked of those in the control group because it does not apply to them since they did not do the cognitive training. | Posted | Mean | Standard Deviation | score on a scale | ~12 weeks |
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|
|
| Primary | Cognitive Training Preferences | Investigators administer a qualitative (i.e., open-ended responses) survey to assess what participants liked/disliked (i.e. preferences) about the training and how to improve it. These verbal responses were then coded into categories for those who were assigned to the EFT group. | This question was not asked of those in the control group because it does not apply to them since they did not do the cognitive training. | Posted | Number | participants | ~12 weeks |
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|
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| Primary | Hours of Cognitive Training Completed | Investigators calculated the hours of training completed. Ranges will be from 0 to 20 hours (i.e., 0% to 100%). | This was not calculated for the control group because it does not apply to them since they did not do the cognitive training. | Posted | Mean | Full Range | 0 to 20 hours of training | From enrollment through completion on average around 12 weeks |
|
|
|
| Primary | Attrition Rates (After Study Data Collection) | Investigators calculated the attrition rate of the protocol as measured by those who completed a posttest assessment; this was the indicator that participants completed the study. | Posted | Count of Participants | Participants | From enrollment through completion on average around 12 weeks |
|
|
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| Secondary | Cognitive Inconsistency (Cognitive Intra-individual Variability) | Cognitive Inconsistency (a type of cognitive intra-individual variability) was calculated with Variability (measures consistency of participants hit reaction times during the test) and Hit Rate Standard Deviation (measures consistency of response speed). These are measured in T scores; 50 indicates a population mean with a standard deviation of 10. Higher T scores indicate more inconsistency, which is considered a poorer cognitive indicator. There is no clinically relevant threshold. | Posted | Mean | Standard Deviation | T-score | ~12 weeks |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Executive Functioning Training | BrainHQ (POSIT Science Inc.) computerized cognitive training modules were used as in our other studies; but these focused on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises. | 0 | 60 | 0 | 60 | 0 | 60 |
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| Title | Measurements |
|---|---|
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| Liked the Stimulation |
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| Disliked Repetition |
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| Disliked Too Difficult |
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| Disliked Boring |
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| Disliked It Being Too Long (time) |
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