HivNCT04345484
Action for Brain Health Now: Ready, Set, Go
A study testing Goal-management training in people with Hiv, run by McGill University at 4 sites in Canada.
Trial summary
HIV (human immunodeficiency virus) can have subtle but important effects on the brain, leading to difficulties in memory, concentration, or problem solving. Goal-setting interventions have been shown to help individuals maintain their physical activity in order to improve brain health. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- Goal-management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesCanada
- Study dates
- Jul 2020to Apr 2025
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ for at least 1 year
- Able to communicate adequately in either French or English
- Able to give written informed consent
- One or more indicators of cognitive frailty (B-CAM<20, C3Q <60%) OR those that do not meet the criteria of successful aging (<7 subscales of SF-36 ≥Canadian Norms)
Who cannot join
- Dementia (MSK-rating stage 3 or more-cognitive component only
- Life expectancy < 3 years or other personal factor limiting the ability to participate in follow-up
- Non-HIV-related neurological disorder likely to affect cognition
- Known active CNS opportunistic infection or hepatitis C requiring IFN treatment during the follow-up period
- Known psychotic disorder
- Current substance dependence or abuse within the past 12 months
- People who have a medical contraindication to moderate exercise (walking for 10 minutes)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Clinique médicale Urbaine Quartier Latin
Montreal, Quebec, H2L 4E9
Benoit Trottier
Clinique Medicale L'Actuel
Montreal, Quebec, H2L 4P9
Réjean Thomas
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Nancy Mayo, PhD
The John Ruedy Immunodeficiency Clinic
Vancouver, British Columbia, V6Z 1Y6
Marianne Harris
About this study
Official title: Action for Positive Brain Health Now: Ready, Set, Go
HIV (human immunodeficiency virus) can have subtle but important effects on the brain, leading to difficulties in memory, concentration, or problem solving. Goal-setting interventions have been shown to help individuals maintain their physical activity in order to improve brain health. The study objective is to estimate the extent to which goal management training before a personalized healthy lifestyle program is associated with greater adherence to health recommendations, achievement of health-related goals, and better brain health and general health outcomes compared to the healthy lifestyle program alone. Participants will be randomized to either Goal Management Training (GMT) and a Healthy Lifestyle Program (HLP) or the control group (HLP alone).
Read the detailed description
Based on healthy aging research in HIV- populations, it is already known that many older people living with HIV could protect or improve their brain health through lifestyle change . However, no intervention is effective if it is not done. Sustained lifestyle change is hard for everyone, but expected to be harder still for those with a chronic condition that affects cognitive ability, eroding the very executive functions needed for effective goal-directed behavior. Thus, the key question is not whether interventions will help brain health in HIV but rather how we can improve adherence to the most promising interventions in people experiencing brain health challenges.
This study will test an innovative approach to enhance adherence to lifestyle interventions, building on feasibility evidence from pilot trials in the Brain Health Now (BHN) study. Goal Management Training (GMT) is a fully manualized cognitive rehabilitation program delivered over 9 weeks in small groups. It targets executive dysfunction, teaching self-management and mindfulness. GMT also trains participants to use explicit strategies to reduce cognitive load in everyday tasks, and methods to cue attention to maintain focus on specific tasks, through weekly 2-h sessions and practice at home. We hypothesize that GMT priming before a personalized Healthy Lifestyle Program (HLP) will improve adherence to that program and subsequently improve health outcomes, compared to the HLP without GMT priming, in cognitively frail men and women living with HIV.
Study objectives
The overall objective of Action for Brain Health Now is to understand, empower and act to protect and improve brain health in HIV, in order to empower patients to take charge of their brain health. This sub-study is directed to the third aim, act. This proposed study addresses the real-world challenge of implementing tailored recommendations, recognizing that the cognitively frail individuals who would benefit the most from lifestyle changes are least equipped to successfully adopt and sustain healthy behaviours. We will trial a novel cognitive rehabilitation approach using goal-management training to boost adherence to a tailored active living intervention.
Specific objective
Estimate the extent to which cognitive rehabilitation before a personalized healthy lifestyle program (HLP) is associated with greater uptake of health recommendations, achievement of health-related goals, and better brain health and general health outcomes compared to the HLP alone.
Methods
Design
A blinded, randomized control trial will be conducted in 100 participants at two sites (Montreal and Vancouver) in order to assess the impact of cognitive rehabilitation on the uptake of a healthy lifestyle program. More specifically, 50 participants will be recruited in Montreal and 50% (i.e. 25 participants) will be assigned to the intervention group and the other 50% (i.e. 25 participants) will be assigned to the control group. The same is true for the site in Vancouver.
Recruitment
The eligibility criteria will be given to the data team who will do a search among the participants and send the investigators a list of ID of potential participants. If these potential participants have agreed, in the main study consent form, to be contacted for sub-studies, they will get a phone call, email or will be contacted directly during a clinic visit by the research coordinator involved in the main study (ABHN). Ethics approval for the Glen site including Royal Victoria Hospital \& Center for Innovative Medicine (CIM) / Montreal, the Clinique Médicale l'Actuel / Montreal and Clinique Médicale Urbaine Quartier Latin / Montreal will be obtained through the MUHC REB. A separate application for the university-based clinic at St-Paul's Hospital / Vancouver will be sent to their own REB for approval.
Intervention
The sample will be drawn from cohort participants. The ABHN full cohort will receive a personalized My Personal Brain Health Dashboard populated directly from their study data accompanied by a document with 7 Simple Tips for Better Brain Health. In addition, the participants of this trial will receive a short list of relevant local resources (e.g. low-cost gyms, community social groups, smoking cessation programs). To test whether a cognitive rehabilitation program will increase healthy lifestyle adherence, people meeting eligibility criteria will be identified and, if in Vancouver or Montreal, offered entry into a randomized trial asking whether priming with GMT will increase adherence to a HLP focused on physical and social activity. All of the participants who agree to enter the trial will be invited to attend the Ready, Set Workshop which will occur before randomization at each site (50 participants per site) and will last approximately four hours long.
Ready: All of the participants will be shown how to best interpret the My Personal Brain Health Dashboard. All of the participants will also be provided with the Garmin vívofit 4 Activity Tracker (worn on the wrist); they will also be trained how to use the Garmin vívofit 4 Activity tracker as well as the mobile app that accompanies it, the SmartAge digital platform for activity tracking and feedback (collaborator Guaraldi). Participants who do not have an app compatible device will be provided with one for the duration of the study.
Set: During the Workshop there will be instruction on SMART goals and demonstration of the My Goals app to use for recording and monitoring goals.
Go: Following the workshop, the participants will be randomized to priming with GMT as they enter the HLP, or to entering the HLP directly. The study period will last 52 weeks for both groups. The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual, which consists of 9 sessions each 2-hours in duration. The control group enters directly into the HLP without any other study visits.
For all the participants, the HLP includes, physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.
In addition, all participants will be assigned a HLP coach to facilitate the transition into using community resources to meet their goals. The HLP coach will provide feedback, encouragement, and suggestions for increasing activity via weekly phone or text interactions throughout the HLP via the SmartAge Digital Platform. The physical activity target will be current Canadian guidelines for older people (150 minutes per week of moderate to vigorous exercise, accumulated in bouts of at least 10 minutes), while the social activity target will be one social event per week. All the strategies in the HLP have evidence for effectiveness.
The participants will also be asked to track the progress of their goals on the MyGoals app and report their participation in any activities they do by taking a picture of something to represent the activity. A research assistant will record the details of the activity (when, what, if it was alone or in a group) and then the picture will be deleted.
- Conditions
- Hiv
- Being tested
- Goal-management training, Control
- Keywords
- Cognition, Exercise, Goal-setting, Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-management trainingBehavioural
9-week goal-management program
ControlBehavioural
Healthy Lifestyle Program
| Study group | Role | What they receive |
|---|---|---|
| GMT Intervention + Health Lifestyle Program | Experimental | The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual and which consists of 9 sessions each 2-hours in duration. They will also participate in the Healthy Lifestyle Program (HLP), which includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability. Receives: Behavioral: Goal-management training |
| Health Lifestyle Program | Active comparator | The control group enters directly into the HLP without any other study visits. The HLP includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Number of weeks in which physical activity guidelines are met (150 min of moderate to vigorous activity in bouts of 10 minutes)
Measured: 0 and 12 months
Change in social activity
Number of weeks in which at least one organized social activity was attended
Measured: 0 and 12 months
Secondary outcomes (10)
Change in goal attainment
Measured by number and diversity of goals set and met
Measured: 0 and 12 months
Change in physical Activity pattern
Measured by Garmin vívofit 4 Activity Tracker (daily step counts, time spent in various cadence bands, sitting time)
Measured: 0 and 12 months
Change in general health perception
Measured using Visual Analogue Health States (minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in sleep
Measured using Visual Analogue Health States (minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in distress
Measured using Visual Analogue Health States (minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in pain
Measured using Visual Analogue Health States(minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in fatigue
Measured using Visual Analogue Health States(minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in depression
Measured using Visual Analogue Health States(minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in anxiety
Measured using Visual Analogue Health States(minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Change in quality of life
Measured using Visual Analogue Health States (minimum score: 0, maximum score: 10; higher scores indicate a better outcome)
Measured: 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy Mayo, PhD, Principal investigator, McGill UniversityMarie-Josée Brouillette, MD, Principal investigator, McGill UniversityLesley Fellows, PhD/MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345484
- Sponsor's protocol ID
- 2020-6202
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quigley A, Brouillette MJ, Fellows LK, Mayo N. Action for better brain health among people living with HIV: protocol for a randomized controlled trial. BMC Infect Dis. 2021 Aug 20;21(1):843. doi: 10.1186/s12879-021-06540-7.
PubMed 34416849
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action for Positive Brain Health Now: Ready, Set, Go
- ClinicalTrials.gov ID
- NCT04345484
- Acronym / sponsor ID
- 2020-6202
- Conditions
- Hiv
- Keywords
- Cognition, Exercise, Goal-setting, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 14 Apr 2020 (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.
HIV (human immunodeficiency virus) can have subtle but important effects on the brain, leading to difficulties in memory, concentration, or problem solving. Goal-setting interventions have been shown to help individuals maintain their physical activity in order to improve brain health. The study objective is to estimate the extent to which goal management training before a personalized healthy lifestyle program is associated with greater adherence to health recommendations, achievement of health-related goals, and better brain health and general health outcomes compared to the healthy lifestyle program alone. Participants will be randomized to either Goal Management Training (GMT) and a Healthy Lifestyle Program (HLP) or the control group (HLP alone).
Detailed description
Based on healthy aging research in HIV- populations, it is already known that many older people living with HIV could protect or improve their brain health through lifestyle change . However, no intervention is effective if it is not done. Sustained lifestyle change is hard for everyone, but expected to be harder still for those with a chronic condition that affects cognitive ability, eroding the very executive functions needed for effective goal-directed behavior. Thus, the key question is not whether interventions will help brain health in HIV but rather how we can improve adherence to the most promising interventions in people experiencing brain health challenges.
This study will test an innovative approach to enhance adherence to lifestyle interventions, building on feasibility evidence from pilot trials in the Brain Health Now (BHN) study. Goal Management Training (GMT) is a fully manualized cognitive rehabilitation program delivered over 9 weeks in small groups. It targets executive dysfunction, teaching self-management and mindfulness. GMT also trains participants to use explicit strategies to reduce cognitive load in everyday tasks, and methods to cue attention to maintain focus on specific tasks, through weekly 2-h sessions and practice at home. We hypothesize that GMT priming before a personalized Healthy Lifestyle Program (HLP) will improve adherence to that program and subsequently improve health outcomes, compared to the HLP without GMT priming, in cognitively frail men and women living with HIV.
Study objectives
The overall objective of Action for Brain Health Now is to understand, empower and act to protect and improve brain health in HIV, in order to empower patients to take charge of their brain health. This sub-study is directed to the third aim, act. This proposed study addresses the real-world challenge of implementing tailored recommendations, recognizing that the cognitively frail individuals who would benefit the most from lifestyle changes are least equipped to successfully adopt and sustain healthy behaviours. We will trial a novel cognitive rehabilitation approach using goal-management training to boost adherence to a tailored active living intervention.
Specific objective
Estimate the extent to which cognitive rehabilitation before a personalized healthy lifestyle program (HLP) is associated with greater uptake of health recommendations, achievement of health-related goals, and better brain health and general health outcomes compared to the HLP alone.
Methods
Design
A blinded, randomized control trial will be conducted in 100 participants at two sites (Montreal and Vancouver) in order to assess the impact of cognitive rehabilitation on the uptake of a healthy lifestyle program. More specifically, 50 participants will be recruited in Montreal and 50% (i.e. 25 participants) will be assigned to the intervention group and the other 50% (i.e. 25 participants) will be assigned to the control group. The same is true for the site in Vancouver.
Recruitment
The eligibility criteria will be given to the data team who will do a search among the participants and send the investigators a list of ID of potential participants. If these potential participants have agreed, in the main study consent form, to be contacted for sub-studies, they will get a phone call, email or will be contacted directly during a clinic visit by the research coordinator involved in the main study (ABHN). Ethics approval for the Glen site including Royal Victoria Hospital \& Center for Innovative Medicine (CIM) / Montreal, the Clinique Médicale l'Actuel / Montreal and Clinique Médicale Urbaine Quartier Latin / Montreal will be obtained through the MUHC REB. A separate application for the university-based clinic at St-Paul's Hospital / Vancouver will be sent to their own REB for approval.
Intervention
The sample will be drawn from cohort participants. The ABHN full cohort will receive a personalized My Personal Brain Health Dashboard populated directly from their study data accompanied by a document with 7 Simple Tips for Better Brain Health. In addition, the participants of this trial will receive a short list of relevant local resources (e.g. low-cost gyms, community social groups, smoking cessation programs). To test whether a cognitive rehabilitation program will increase healthy lifestyle adherence, people meeting eligibility criteria will be identified and, if in Vancouver or Montreal, offered entry into a randomized trial asking whether priming with GMT will increase adherence to a HLP focused on physical and social activity. All of the participants who agree to enter the trial will be invited to attend the Ready, Set Workshop which will occur before randomization at each site (50 participants per site) and will last approximately four hours long.
Ready: All of the participants will be shown how to best interpret the My Personal Brain Health Dashboard. All of the participants will also be provided with the Garmin vívofit 4 Activity Tracker (worn on the wrist); they will also be trained how to use the Garmin vívofit 4 Activity tracker as well as the mobile app that accompanies it, the SmartAge digital platform for activity tracking and feedback (collaborator Guaraldi). Participants who do not have an app compatible device will be provided with one for the duration of the study.
Set: During the Workshop there will be instruction on SMART goals and demonstration of the My Goals app to use for recording and monitoring goals.
Go: Following the workshop, the participants will be randomized to priming with GMT as they enter the HLP, or to entering the HLP directly. The study period will last 52 weeks for both groups. The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual, which consists of 9 sessions each 2-hours in duration. The control group enters directly into the HLP without any other study visits.
For all the participants, the HLP includes, physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.
In addition, all participants will be assigned a HLP coach to facilitate the transition into using community resources to meet their goals. The HLP coach will provide feedback, encouragement, and suggestions for increasing activity via weekly phone or text interactions throughout the HLP via the SmartAge Digital Platform. The physical activity target will be current Canadian guidelines for older people (150 minutes per week of moderate to vigorous exercise, accumulated in bouts of at least 10 minutes), while the social activity target will be one social event per week. All the strategies in the HLP have evidence for effectiveness.
The participants will also be asked to track the progress of their goals on the MyGoals app and report their participation in any activities they do by taking a picture of something to represent the activity. A research assistant will record the details of the activity (when, what, if it was alone or in a group) and then the picture will be deleted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMT Intervention + Health Lifestyle Program | Experimental | Behavioral: Goal-management trainingThe intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual and which consists of 9 sessions each 2-hours in duration. They will also participate in the Healthy Lifestyle Program (HLP), which includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability. |
| Health Lifestyle Program | Active comparator | Behavioral: ControlThe control group enters directly into the HLP without any other study visits. The HLP includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV+ for at least 1 year
- Able to communicate adequately in either French or English
- Able to give written informed consent
- One or more indicators of cognitive frailty (B-CAM<20, C3Q <60%) OR those that do not meet the criteria of successful aging (<7 subscales of SF-36 ≥Canadian Norms)
Key exclusion criteria (7 listed)
- Dementia (MSK-rating stage 3 or more-cognitive component only
- Life expectancy < 3 years or other personal factor limiting the ability to participate in follow-up
- Non-HIV-related neurological disorder likely to affect cognition
- Known active CNS opportunistic infection or hepatitis C requiring IFN treatment during the follow-up period
- Known psychotic disorder
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 |
|---|---|---|
| Goal-management training9-week goal-management program | Behavioural | GMT Intervention + Health Lifestyle Program |
| ControlHealthy Lifestyle Program | Behavioural | Health Lifestyle Program |
Primary outcome
Change in physical activity
Time frame: 0 and 12 months
Number of weeks in which physical activity guidelines are met (150 min of moderate to vigorous activity in bouts of 10 minutes)
Change in social activity
Time frame: 0 and 12 months
Number of weeks in which at least one organized social activity was attended
10 secondary outcomes
Change in goal attainment
Time frame: 0 and 12 months
Change in physical Activity pattern
Time frame: 0 and 12 months
Change in general health perception
Time frame: 0 and 12 months
Change in sleep
Time frame: 0 and 12 months
Change in distress
Time frame: 0 and 12 months
Change in pain
Time frame: 0 and 12 months
Change in fatigue
Time frame: 0 and 12 months
Change in depression
Time frame: 0 and 12 months
Change in anxiety
Time frame: 0 and 12 months
Change in quality of life
Time frame: 0 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 34416849Quigley A, Brouillette MJ, Fellows LK, Mayo N. Action for better brain health among people living with HIV: protocol for a randomized controlled trial. BMC Infect Dis. 2021 Aug 20;21(1):843. doi: 10.1186/s12879-021-06540-7.
- Individual participant dataSharing planned: No
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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.
Nancy Mayo, PhD principal investigator
McGill University
Marie-Josée Brouillette, MD principal investigator
McGill University
Lesley Fellows, PhD/MD principal investigator
McGill University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-management training in people with Hiv, run by McGill University at 4 sites in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adria Quigley, PhD ((514) 934-1934, adria.quigley@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: 0 and 12 months). The study lists 2 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 NCT04345484, which also lists 1 linked publication.
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 14 Apr 2020.