HIVTNTNCT05773430
The Targeted Neurocognitive Training (TNT) Study
A study testing Targeted Neurocognitive Training in people with HIV and Aging, run by University of Alabama at Birmingham.
Trial summary
People with HIV (PWH) often suffer from cognitive impairments known as HIV-Associated Neurocognitive Disorder (HAND). Cognitive impairments in PWH are not fully captured by traditional neurocognitive assessment; thus, we must examine cognitive performance both within a task (inconsistency) and across cognitive domains… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Aging, Cognitive Function Abnormal
- What is being tested?
- Targeted Neurocognitive Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jul 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants (men \& women) must be 40+ years
- English speaking,
- Have HIV-Associated Neurocognitive Disorder (HAND)
- Willing to meet in person
- Has time to participate for ~12 weeks
Who cannot join
- Participants living beyond 60 miles away from the center
- Participants living in unstable housing (e.g., halfway house)
- Participants with significant neuromedical comorbidities (e.g., schizophrenia)
- Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.
- Participants who have received cognitive training within the past three years- -
About this study
Official title: Reducing Cognitive Intra-Individual Variability and Cognitive Impairment in Adults With HIV (The Targeted Neurocognitive Training (TNT) Study)
People with HIV (PWH) often suffer from cognitive impairments known as HIV-Associated Neurocognitive Disorder (HAND). Cognitive impairments in PWH are not fully captured by traditional neurocognitive assessment; thus, we must examine cognitive performance both within a task (inconsistency) and across cognitive domains (dispersion), called Intra-Individual Variability (IIV). IIV predicts cognitive impairment/decline, altered brain morphology, and neuropathology in many clinical populations. Conceptually, IIV results from "executive dyscontrol" or the efficiency (or inefficiency) with which executive control processes coordinate other cognitive processes/domains. Based on the Executive Dyscontrol Hypothesis and underlying calculations of IIV, one way to improve cognition in PWH is through interventions that target improvements in their most severely impaired cognitive domains. We hypothesize such improvements, in turn, should reduce the strain placed on executive functioning resources, freeing up resources needed to compensate for impairments in any domain and, in turn, reducing IIV. Computerized cognitive training, widely used in the study team's prior work, is ideally suited to target impairments in select cognitive domains using computerized cognitive training. In our systematic review of 13 cognitive training studies in PWH, we found cognitive training improved performance in the targeted domain. In this feasibility study, we will assess 150 PWH at baseline with the expectation to recruit 120 PWH with HAND. Then we will use a two-group pre-post experimental design of 120 adults with HAND including: 1) a Targeted Neurocognitive Training (TNT) group (n=60) to train each participant's two most impaired cognitive domains (e.g., attention \& memory) assessed from a neurocognitive battery at baseline, and 2) a no-contact control group (n=60). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention. Exploratory Aim 1 - Cognition: Compare adults who receive TNT to those who receive no training to determine whether they improve on the cognitive domains trained, show less cognitive IIV across domains and within a task, and demonstrate improved executive functioning. Exploratory Hypothesis 1: TNT will improve cognitive functioning in the targeted impaired cognitive domains. Exploratory Hypothesis 2: TNT will reduce cognitive IIV (both overall dispersion \& inconsistency). Exploratory Hypothesis 3: TNT will improve executive functioning. Exploratory Hypothesis 4: TNT will improve global cognition and reduce HAND severity. Innovation 1 - This is the first study to use IIV to guide cognitive training to target the most impaired cognitive domains to reduce cognitive IIV in HIV. Innovation 2 - This will be one of the first studies to prospectively include both types of cognitive IIV - dispersion and inconsistency - allowing us to examine the relationship between dispersion and inconsistency. Innovation 3 - The epicenter of HIV is in the Deep South where this study will occur.
Read the detailed description
OVERALL -- A pre-post twoe-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.
Targeted Neurocognitive Training (TNT) Group. Only two cognitive domains will be targeted for training (10 hrs of training in each, for a total of 20 hours). Two or more cognitive exercises may be employed within a cognitive domain. These exercises provide both immediate and intermittent feedback and are customized to the participants' individual ability; the difficulty and/or complexity of each game are systematically decreased/increased based on participants' performance to always be challenging, but not overly frustrating. Typically, in an hour session, one exercise (e.g., Mental Map) will be engaged at a time (20-30 minutes) before switching to another exercise (e.g., Hawkeye) in another domain for 20-30 minutes. This helps the participant remain engaged but avoid fatigue.
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.
- Conditions
- HIV, Aging, Cognitive Function Abnormal, Cognitive Training, Older Adults
- Being tested
- Targeted Neurocognitive Training
- Keywords
- HIV-Associated Neurocognitive Disorder, cognitive training, executive dysfunction, feasibility
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Neurocognitive TrainingBehavioural
Only two cognitive domains will be targeted for training (10 hrs of training in each, for a total of 20 hours). Two or more cognitive exercises may be employed within a cognitive domain. These exercises provide both immediate and intermittent feedback and are customized to the participants' individual ability; the difficulty and/or complexity of each game are systematically decreased/increased based on participants' performance to always be challenging, but not overly frustrating. Typically, in an hour session, one exercise (e.g., Mental Map) will be engaged at a time (20-30 minutes) before switching to another exercise (e.g., Hawkeye) in another domain for 20-30 minutes. This helps the participant remain engaged but avoid fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Neurocognitive Training | Experimental | BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on the two cognitive domains in which the participants exhibited the worst performance at baseline. Twenty hours or training will administer to each participant target these two cognitive domains (10 hours each). 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. Receives: Behavioral: Targeted Neurocognitive Training |
| No-Contact Control Group | No intervention | These participants will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Assessment of Cognitive Training
All participants at baseline will be asked questions about computer use, knowledge about cognitive training, their perceptions about whether they need cognitive training, knowledge about HIV and cognition, etc. Both quantitative and qualitative (i.e., open-ended responses) data will be collected; this is similar to our other studies
Measured: ~12 weeks
Cognitive Training Satisfaction Questionnaire
Used to assess likes/dislikes of the intervention, both quantitative questions and qualitative (i.e., open-ended responses) data are gathered as has been used in our previous cognitive intervention studies to evaluate feasibility and acceptability.
Measured: ~12 weeks
Exit Survey
Investigators will administer a brief quantitative and qualitative (i.e., open-ended responses) survey to assess what he/she liked/disliked about the training and how to improve it.
Measured: ~12 weeks
Adherence Rates (after study data collection)
Investigators will calculate the adherence rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.
Measured: Through study completion, an average of 2 years
Attrition Rates (after study data collection)
Investigators will calculate the attrition rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)
Cognitive data will be gathered via BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning), supported by NIMH R42099964 and Digital Artefacts/UCSD) is a HIPAA compliant tablet-based cognitive assessment platform. This self-administered tool is not literacy dependent (i.e., automated audio/video instructions) and uses validated cognitive tests sensitive to mild-to-moderate cognitive impairments.
Measured: ~12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 May 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: It was never funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- A pre-post two-group experimental design will be used. One group will receive the experimental targeted neurocognitive training and the other group will not receive anything (no-contact control group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773430
- Sponsor's protocol ID
- IRB-300010567
- Other IDs
- UAB
- Acronym
- TNT
- Status last verified
- May 2026
- First submitted
- 6 Mar 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will archive all data electronically without PHI which will be available upon request.
Publications
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.
PubMed 30710223Vance 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.
PubMed 33733311Waldrop 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 33449578
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cognitive Intra-Individual Variability and Cognitive Impairment in Adults With HIV (The Targeted Neurocognitive Training (TNT) Study)
- ClinicalTrials.gov ID
- NCT05773430
- Acronym / sponsor ID
- TNT / IRB-300010567
- Conditions
- HIV, Aging, Cognitive Function Abnormal, Cognitive Training, Older Adults
- Keywords
- HIV-Associated Neurocognitive Disorder, cognitive training, executive dysfunction, feasibility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was never funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Mar 2023 (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.
People with HIV (PWH) often suffer from cognitive impairments known as HIV-Associated Neurocognitive Disorder (HAND). Cognitive impairments in PWH are not fully captured by traditional neurocognitive assessment; thus, we must examine cognitive performance both within a task (inconsistency) and across cognitive domains (dispersion), called Intra-Individual Variability (IIV). IIV predicts cognitive impairment/decline, altered brain morphology, and neuropathology in many clinical populations. Conceptually, IIV results from "executive dyscontrol" or the efficiency (or inefficiency) with which executive control processes coordinate other cognitive processes/domains. Based on the Executive Dyscontrol Hypothesis and underlying calculations of IIV, one way to improve cognition in PWH is through interventions that target improvements in their most severely impaired cognitive domains. We hypothesize such improvements, in turn, should reduce the strain placed on executive functioning resources, freeing up resources needed to compensate for impairments in any domain and, in turn, reducing IIV. Computerized cognitive training, widely used in the study team's prior work, is ideally suited to target impairments in select cognitive domains using computerized cognitive training. In our systematic review of 13 cognitive training studies in PWH, we found cognitive training improved performance in the targeted domain. In this feasibility study, we will assess 150 PWH at baseline with the expectation to recruit 120 PWH with HAND. Then we will use a two-group pre-post experimental design of 120 adults with HAND including: 1) a Targeted Neurocognitive Training (TNT) group (n=60) to train each participant's two most impaired cognitive domains (e.g., attention \& memory) assessed from a neurocognitive battery at baseline, and 2) a no-contact control group (n=60). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention. Exploratory Aim 1 - Cognition: Compare adults who receive TNT to those who receive no training to determine whether they improve on the cognitive domains trained, show less cognitive IIV across domains and within a task, and demonstrate improved executive functioning. Exploratory Hypothesis 1: TNT will improve cognitive functioning in the targeted impaired cognitive domains. Exploratory Hypothesis 2: TNT will reduce cognitive IIV (both overall dispersion \& inconsistency). Exploratory Hypothesis 3: TNT will improve executive functioning. Exploratory Hypothesis 4: TNT will improve global cognition and reduce HAND severity. Innovation 1 - This is the first study to use IIV to guide cognitive training to target the most impaired cognitive domains to reduce cognitive IIV in HIV. Innovation 2 - This will be one of the first studies to prospectively include both types of cognitive IIV - dispersion and inconsistency - allowing us to examine the relationship between dispersion and inconsistency. Innovation 3 - The epicenter of HIV is in the Deep South where this study will occur.
Detailed description
OVERALL -- A pre-post twoe-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.
Targeted Neurocognitive Training (TNT) Group. Only two cognitive domains will be targeted for training (10 hrs of training in each, for a total of 20 hours). Two or more cognitive exercises may be employed within a cognitive domain. These exercises provide both immediate and intermittent feedback and are customized to the participants' individual ability; the difficulty and/or complexity of each game are systematically decreased/increased based on participants' performance to always be challenging, but not overly frustrating. Typically, in an hour session, one exercise (e.g., Mental Map) will be engaged at a time (20-30 minutes) before switching to another exercise (e.g., Hawkeye) in another domain for 20-30 minutes. This helps the participant remain engaged but avoid fatigue.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A pre-post two-group experimental design will be used. One group will receive the experimental targeted neurocognitive training and the other group will not receive anything (no-contact control group)
| Arm | Type | Receives |
|---|---|---|
| Targeted Neurocognitive Training | Experimental | Behavioral: Targeted Neurocognitive TrainingBrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on the two cognitive domains in which the participants exhibited the worst performance at baseline. Twenty hours or training will administer to each participant target these two cognitive domains (10 hours each). 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. |
| No-Contact Control Group | No intervention | –These participants will not receive any intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants (men \& women) must be 40+ years
- English speaking,
- Have HIV-Associated Neurocognitive Disorder (HAND)
- Willing to meet in person
- Has time to participate for ~12 weeks
Key exclusion criteria (5 listed)
- Participants living beyond 60 miles away from the center
- Participants living in unstable housing (e.g., halfway house)
- Participants with significant neuromedical comorbidities (e.g., schizophrenia)
- Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.
- Participants who have received cognitive training within the past three years- -
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 |
|---|---|---|
| Targeted Neurocognitive TrainingOnly two cognitive domains will be targeted for training (10 hrs of training in each, for a total of 20 hours). Two or more cognitive exercises may be employed within a cognitive domain. These exercises provide both immediate and intermittent feedback and are customized to the participants' individual ability; the difficulty and/or complexity of each game are systematically decreased/increased based on participants' performance to always be challenging, but not overly frustrating. Typically, in an hour session, one exercise (e.g., Mental Map) will be engaged at a time (20-30 minutes) before switching to another exercise (e.g., Hawkeye) in another domain for 20-30 minutes. This helps the participant remain engaged but avoid fatigue. | Behavioural | Targeted Neurocognitive Training |
Primary outcome
Baseline Assessment of Cognitive Training
Time frame: ~12 weeks
All participants at baseline will be asked questions about computer use, knowledge about cognitive training, their perceptions about whether they need cognitive training, knowledge about HIV and cognition, etc. Both quantitative and qualitative (i.e., open-ended responses) data will be collected; this is similar to our other studies
Cognitive Training Satisfaction Questionnaire
Time frame: ~12 weeks
Used to assess likes/dislikes of the intervention, both quantitative questions and qualitative (i.e., open-ended responses) data are gathered as has been used in our previous cognitive intervention studies to evaluate feasibility and acceptability.
Exit Survey
Time frame: ~12 weeks
Investigators will administer a brief quantitative and qualitative (i.e., open-ended responses) survey to assess what he/she liked/disliked about the training and how to improve it.
Adherence Rates (after study data collection)
Time frame: Through study completion, an average of 2 years
Investigators will calculate the adherence rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.
Attrition Rates (after study data collection)
Time frame: Through study completion, an average of 2 years
Investigators will calculate the attrition rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.
1 secondary outcome
BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)
Time frame: ~12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Results publication: PubMed 30710223Vance 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.
- Results publication: PubMed 33733311Vance 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.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. We will archive all data electronically without PHI which will be available upon request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Neurocognitive Training in people with HIV and Aging, run by University of Alabama at Birmingham.
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 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: withdrawn, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Baseline Assessment of Cognitive Training (time frame: ~12 weeks). The study lists 5 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 NCT05773430, which also lists 3 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 29 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.