Goal-Management Training for HIV

Recruiting at 3 trial locations

Overseen By Adria Quigley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Dementia, Neurological disorder, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Nancy Mayo, PhD

Principal Investigator

McGill University

Marie-Josée Brouillette, MD

Principal Investigator

McGill University

Lesley Fellows, PhD/MD

Principal Investigator

McGill University

Eligibility Criteria

This trial is for individuals who have been living with HIV for at least a year, can consent in French or English, and show signs of cognitive frailty or don't meet 'successful aging' criteria. It's not suitable for those unable to do moderate exercise, with a life expectancy under 3 years, active brain infections, hepatitis C needing treatment during the study, dementia affecting cognition, other neurological disorders impacting thinking skills, psychosis or recent substance abuse.

Inclusion Criteria

HIV+ for at least 1 year

I can communicate well in either French or English.

Able to give written informed consent

Exclusion Criteria

Life expectancy < 3 years or other personal factor limiting the ability to participate in follow-up

Known psychotic disorder

Current substance dependence or abuse within the past 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ready, Set Workshop

Participants attend a workshop to learn about the My Personal Brain Health Dashboard and receive training on using the Garmin vívofit 4 Activity Tracker and the My Goals app.

1 day

1 visit (in-person)

Treatment

Participants are randomized to either Goal Management Training (GMT) with Healthy Lifestyle Program (HLP) or HLP alone. The GMT group undergoes 9 sessions of cognitive rehabilitation over 9 weeks.

52 weeks

9 visits (in-person) for GMT group

Follow-up

Participants are monitored for adherence to health recommendations and achievement of health-related goals.

12 months

Treatment Details

Interventions

• Control
• Goal-management training

Trial Overview The trial tests if adding Goal Management Training (GMT) to a Healthy Lifestyle Program (HLP) leads to better adherence to health recommendations and outcomes than the HLP alone. Participants will be randomly assigned either GMT plus HLP or just HLP and their brain health and general health outcomes will be compared.

Participant Groups

Group I: GMT Intervention + Health Lifestyle Program Experimental Treatment 1 Intervention

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.

Group II: Health Lifestyle Program Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+