HIV InfectionsNCT00926003
Computerized Cognitive Rehabilitation in Ugandan Children With HIV
A study testing Full Computerized cognitive training and Limited computerized cognitive training in people with HIV Infections, run by Michigan State University at 1 site in Uganda.
Trial summary
One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no training… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Full Computerized cognitive training and Limited computerized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2009to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- HIV children 6 to 16 years of age and enrolled in the CAI program will be eligible should the parent or caregiver consent to participation in the study. They will all be confirmed HIV positive children (ELISA and Western blot). Only children with perinatally acquired HIV infection will be included.
Who cannot join
- At pre-CCRT medical examination (see medical exam form in appendices) we will exclude children with a medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization. Also children with seizure or other neurological disability will be excluded. This will be screened using a brief medical history questionnaire and CAI medical chart review.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children
One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no training intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up post training. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 \& 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children clinically stable on ART will have greater gains than those not stable or virally suppressed on ART. Conclusion: CCRT will prove effective and sustainable for enhancing neurocognitive status in HIV children. Futher work will prove this approach viable for assessing and treating children in resource-poor settings.
Read the detailed description
Aim 1. To evaluate the effectiveness of CCRT in improving cognitive performance outcomes in Ugandan children with HIV.
Hypothesis 1a: CCRT can improve short and long-term cognitive outcomes in children with HIV; Hypothesis 1b: Improvements in performance associated with CCRT are not solely due to increased computer exposure.
One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will undergo baseline neuropsychological testing using the Kaufman Assessment Battery for Children (KABC-2), the computerized Tests of Variables of Attention (TOVA: auditory and visual tests), the brief CogState computerized neuropsychological test battery (CogState), and the Bruininks-Oseretsky Tests of Motor Proficiency (2nd edition) (BOT-2). Cogstate is designed as a neuropsychological screening tool with minimal practice effects and suitable in a repeated measures design for monitoring the benefits of treatment on neurocognitive disability11. Children then will be randomized to either: CCRT intervention group (Captain's Log active rehabilitation), active control group (Captain's Log locked, non-rehabilitation mode), or passive control group (no computer intervention). CCRT or computer controls will be presented over 24 sessions (~ 45 min) for 8 weeks (3 sessions per week). After the 8-weeks, neurocognitive gains will be assessed with CogState and the KABC-2 working memory subscales (primary expected outcome measures). The full KABC-2, TOVA, CogState, and BOT-2 will be re-administered 3 months after the 8-week assessment. Thus, the full battery will be administered at enrollment and at 3-month follow-up, while the most strategic portions of the battery will be administered following the 8 weeks CCRT intervention period. The combined testing will allow us to assess both the short-term and longer-term neuropsychological benefits of CCRT.
Aim 2. To evaluate the effectiveness of CCRT in reducing psychiatric symptoms in Ugandan children with HIV.
Hypothesis 2: CCRT can reduce short- and long-term psychiatric symptoms in children with HIV.
Previously in cerebral malaria survivors, we demonstrated a significant reduction in short-term symptoms related to anxiety, depression, and somatic complaints as assessed by the Achenbach Child Behavior Checklist (CBCL) following CCRT intervention12. In this aim, caregiver-reported psychiatric symptoms on the CBCL will be assessed at enrollment, after the 8-week CCRT intervention period, and 3 months after enrollment. The CBCL assessment will also help us gauge the psychosocial benefits of the social attention and enrichment surrounding computer exposure in the active control condition, rather than the rehabilitative aspects of CCRT per se. This will be evident as we compare the active and passive control groups.
Aim 3. To evaluate how ARV treatment status and clinical response along with corresponding immunological status of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction; .after controlling for quality of home environment, nutrition, and other risk factors of poverty.
Hypothesis 3: Children virally suppressed on ART treatment with a history of fewer opportunistic illnesses and better CD4 counts will have better neuropsychological outcomes in response to CCRT training.The moderating effects of HIV progressive encephalopathy on brain plasticity can also be monitored by CCRT training progress, measures by the Captain's Log Internal Evaluator (CLIE) feature of the CCRT program.
- Conditions
- HIV Infections
- Being tested
- Full Computerized cognitive training, Limited computerized cognitive training
- Keywords
- HIV, Children, Africa, Neuropsychology, cognitive rehabilitation, computers
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Computerized cognitive trainingBehavioural
Also called computerized cognitive games, computerized cognitive rehabilitation therapy (CCRT)
8 weeks of 3 times weekly intervention for 60 min per session with the full titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning
Limited computerized cognitive trainingBehavioural
Also called computerized cognitive rehabilitation therapy (CCRT)
Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training. 8 weeks of 3 times weekly intervention for 60 min per session with the non-titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning).
| Study group | Role | What they receive |
|---|---|---|
| Full Computerized Cognitive Training | Experimental | Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. Each training game become more difficult as the child gains proficiency. Receives: Behavioral: Full Computerized cognitive training |
| Control | No intervention | Passive Control with no intervention training (computer cognitive games) for 8 weeks. |
| Limited computerized cognitive training | Active comparator | Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. In this arm, however, the training games do NOT become progressively more difficult as the child gains proficiency, but rotates randomly among simpler to moderate levels of difficulty for each game. The purpose to to give children int he "limited" CCRT arm comparable exposure to the cognitive games training as with the "full CCRT" arm, with the exception of the titrating nature of the game training. Receives: Behavioral: Limited computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Performance (KABC2)
Kaufman Assessment Battery for Children, 2nd edition (KABC-II) Mental Processing Index (MPI), which is a global cognitive ability performance composite that is a standard score with a mean of 100 and a standard deviation of 15, with scores for our population of children typically ranging from 55 to 130. the MPI is comprised of the standardized global scores for the cognitive domains of Sequential Processing, Simultaneous Processing, Learning, and Planning. These standardized global domain scores are summed and converted (on the basis of age of child, using American norms) to a composite global performance measure called the Mental Processing Index (MPI) standard score (T score). Higher T scores indicate better performance and a better neuropsychological outcome.
Measured: KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.
Secondary outcomes (1)
Achenbach Child Behavior Checklist (CBCL) Total Score
Child Behavior Checklist (CBCL) total score Total problems T-scores (standardized). This is a standardized score with a mean of 50 and a standard deviation of 10, with higher scores indicating more symptoms of either emotional (internalizing) or behavioral (externalizing) or other (e.g., sleep disturbances) nature. Range for our children on this scale is typically from 40 to 80. These are t scores based on Cross-Cultural norms, whereby higher scores (more symptoms or problems) indicate a worse outcome.
Measured: CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Health Uganda LTD, University of Michigan
- Responsible party
- Principal investigator, Michael J. Boivin, Michigan State University
- Investigators
- Michael J. Boivin, PhD, MPH, Study director, MSU Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926003
- Sponsor's protocol ID
- BIRB 07-709
- Other IDs
- R34MH085631
- Status last verified
- Mar 2019
- First submitted
- 22 Jun 2009
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ruisenor-Escudero H, Familiar I, Nakasujja N, Bangirana P, Opoka R, Giordani B, Boivin M. Immunological correlates of behavioral problems in school-aged children living with HIV in Kayunga, Uganda. Glob Ment Health (Camb). 2015 Jun 25;2:e9. doi: 10.1017/gmh.2015.7. eCollection 2015.
PubMed 28596857Giordani B, Novak B, Sikorskii A, Bangirana P, Nakasujja N, Winn BM, Boivin MJ. Designing and evaluating Brain Powered Games for cognitive training and rehabilitation in at-risk African children. Glob Ment Health (Camb). 2015 May 29;2:e6. doi: 10.1017/gmh.2015.5. eCollection 2015.
PubMed 28596854Boivin MJ, Nakasujja N, Sikorskii A, Opoka RO, Giordani B. A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV. AIDS Res Hum Retroviruses. 2016 Aug;32(8):743-55. doi: 10.1089/AID.2016.0026. Epub 2016 May 2.
PubMed 27045714
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children
- ClinicalTrials.gov ID
- NCT00926003
- Acronym / sponsor ID
- BIRB 07-709
- Conditions
- HIV Infections
- Keywords
- HIV, Children, Africa, Neuropsychology, cognitive rehabilitation, computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Global Health Uganda LTD, University of Michigan
- Study start
- Oct 2009 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no training intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up post training. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 \& 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children clinically stable on ART will have greater gains than those not stable or virally suppressed on ART. Conclusion: CCRT will prove effective and sustainable for enhancing neurocognitive status in HIV children. Futher work will prove this approach viable for assessing and treating children in resource-poor settings.
Detailed description
Aim 1. To evaluate the effectiveness of CCRT in improving cognitive performance outcomes in Ugandan children with HIV.
Hypothesis 1a: CCRT can improve short and long-term cognitive outcomes in children with HIV; Hypothesis 1b: Improvements in performance associated with CCRT are not solely due to increased computer exposure.
One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will undergo baseline neuropsychological testing using the Kaufman Assessment Battery for Children (KABC-2), the computerized Tests of Variables of Attention (TOVA: auditory and visual tests), the brief CogState computerized neuropsychological test battery (CogState), and the Bruininks-Oseretsky Tests of Motor Proficiency (2nd edition) (BOT-2). Cogstate is designed as a neuropsychological screening tool with minimal practice effects and suitable in a repeated measures design for monitoring the benefits of treatment on neurocognitive disability11. Children then will be randomized to either: CCRT intervention group (Captain's Log active rehabilitation), active control group (Captain's Log locked, non-rehabilitation mode), or passive control group (no computer intervention). CCRT or computer controls will be presented over 24 sessions (~ 45 min) for 8 weeks (3 sessions per week). After the 8-weeks, neurocognitive gains will be assessed with CogState and the KABC-2 working memory subscales (primary expected outcome measures). The full KABC-2, TOVA, CogState, and BOT-2 will be re-administered 3 months after the 8-week assessment. Thus, the full battery will be administered at enrollment and at 3-month follow-up, while the most strategic portions of the battery will be administered following the 8 weeks CCRT intervention period. The combined testing will allow us to assess both the short-term and longer-term neuropsychological benefits of CCRT.
Aim 2. To evaluate the effectiveness of CCRT in reducing psychiatric symptoms in Ugandan children with HIV.
Hypothesis 2: CCRT can reduce short- and long-term psychiatric symptoms in children with HIV.
Previously in cerebral malaria survivors, we demonstrated a significant reduction in short-term symptoms related to anxiety, depression, and somatic complaints as assessed by the Achenbach Child Behavior Checklist (CBCL) following CCRT intervention12. In this aim, caregiver-reported psychiatric symptoms on the CBCL will be assessed at enrollment, after the 8-week CCRT intervention period, and 3 months after enrollment. The CBCL assessment will also help us gauge the psychosocial benefits of the social attention and enrichment surrounding computer exposure in the active control condition, rather than the rehabilitative aspects of CCRT per se. This will be evident as we compare the active and passive control groups.
Aim 3. To evaluate how ARV treatment status and clinical response along with corresponding immunological status of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction; .after controlling for quality of home environment, nutrition, and other risk factors of poverty.
Hypothesis 3: Children virally suppressed on ART treatment with a history of fewer opportunistic illnesses and better CD4 counts will have better neuropsychological outcomes in response to CCRT training.The moderating effects of HIV progressive encephalopathy on brain plasticity can also be monitored by CCRT training progress, measures by the Captain's Log Internal Evaluator (CLIE) feature of the CCRT program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Computerized Cognitive Training | Experimental | Behavioral: Full Computerized cognitive trainingIntervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. Each training game become more difficult as the child gains proficiency. |
| Control | No intervention | –Passive Control with no intervention training (computer cognitive games) for 8 weeks. |
| Limited computerized cognitive training | Active comparator | Behavioral: Limited computerized cognitive trainingIntervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week). A training session lasts about an hour and consists of 9 training games or programs, 3 pertaining to improving attention, 3 pertaining to improving visual-spatial memory, and 3 pertaining to improving reasoning/planning. In this arm, however, the training games do NOT become progressively more difficult as the child gains proficiency, but rotates randomly among simpler to moderate levels of difficulty for each game. The purpose to to give children int he "limited" CCRT arm comparable exposure to the cognitive games training as with the "full CCRT" arm, with the exception of the titrating nature of the game training. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- HIV children 6 to 16 years of age and enrolled in the CAI program will be eligible should the parent or caregiver consent to participation in the study. They will all be confirmed HIV positive children (ELISA and Western blot). Only children with perinatally acquired HIV infection will be included.
Key exclusion criteria (1 listed)
- At pre-CCRT medical examination (see medical exam form in appendices) we will exclude children with a medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization. Also children with seizure or other neurological disability will be excluded. This will be screened using a brief medical history questionnaire and CAI medical chart review.
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 |
|---|---|---|
| Full Computerized cognitive trainingAlso: computerized cognitive games, computerized cognitive rehabilitation therapy (CCRT)8 weeks of 3 times weekly intervention for 60 min per session with the full titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning | Behavioural | Full Computerized Cognitive Training |
| Limited computerized cognitive trainingAlso: computerized cognitive rehabilitation therapy (CCRT)Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training. 8 weeks of 3 times weekly intervention for 60 min per session with the non-titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning). | Behavioural | Limited computerized cognitive training |
Primary outcome
Neuropsychological Performance (KABC2)
Time frame: KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.
Kaufman Assessment Battery for Children, 2nd edition (KABC-II) Mental Processing Index (MPI), which is a global cognitive ability performance composite that is a standard score with a mean of 100 and a standard deviation of 15, with scores for our population of children typically ranging from 55 to 130. the MPI is comprised of the standardized global scores for the cognitive domains of Sequential Processing, Simultaneous Processing, Learning, and Planning. These standardized global domain scores are summed and converted (on the basis of age of child, using American norms) to a composite global performance measure called the Mental Processing Index (MPI) standard score (T score). Higher T scores indicate better performance and a better neuropsychological outcome.
1 secondary outcome
Achenbach Child Behavior Checklist (CBCL) Total Score
Time frame: CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28596857Ruisenor-Escudero H, Familiar I, Nakasujja N, Bangirana P, Opoka R, Giordani B, Boivin M. Immunological correlates of behavioral problems in school-aged children living with HIV in Kayunga, Uganda. Glob Ment Health (Camb). 2015 Jun 25;2:e9. doi: 10.1017/gmh.2015.7. eCollection 2015.
- Results publication: PubMed 28596854Giordani B, Novak B, Sikorskii A, Bangirana P, Nakasujja N, Winn BM, Boivin MJ. Designing and evaluating Brain Powered Games for cognitive training and rehabilitation in at-risk African children. Glob Ment Health (Camb). 2015 May 29;2:e6. doi: 10.1017/gmh.2015.5. eCollection 2015.
- Results publication: PubMed 27045714Boivin MJ, Nakasujja N, Sikorskii A, Opoka RO, Giordani B. A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV. AIDS Res Hum Retroviruses. 2016 Aug;32(8):743-55. doi: 10.1089/AID.2016.0026. Epub 2016 May 2.
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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.
Michael J. Boivin, PhD, MPH study director
MSU Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Computerized cognitive training and Limited computerized cognitive training in people with HIV Infections, run by Michigan State University at 1 site in Uganda.
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 1 inclusion and 1 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 6 Mar 2019. 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 Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neuropsychological Performance (KABC2) (time frame: KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.). 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 NCT00926003, 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 6 Mar 2019.