NCT04345484

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

April 8, 2020

Last Update Submit

April 10, 2020

Conditions

Hiv

Keywords

CognitionExerciseGoal-settingIntervention

Outcome Measures

Primary Outcomes (2)

  • 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)

    0 and 12 months

  • Change in social activity

    Number of weeks in which at least one organized social activity was attended

    0 and 12 months

Secondary Outcomes (10)

  • Change in goal attainment

    0 and 12 months

  • Change in physical Activity pattern

    0 and 12 months

  • Change in general health perception

    0 and 12 months

  • Change in sleep

    0 and 12 months

  • Change in distress

    0 and 12 months

  • +5 more secondary outcomes

Other Outcomes (9)

  • Change in energy/fatigue

    0 and 39 weeks

  • Change in mood

    0 and 39 weeks

  • Change in physical function

    0 and 39 weeks

  • +6 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

Goal-management trainingBEHAVIORAL

9-week goal-management program

GMT Intervention + Health Lifestyle Program
ControlBEHAVIORAL

Healthy Lifestyle Program

Health Lifestyle Program

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The John Ruedy Immunodeficiency Clinic

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Clinique médicale Urbaine Quartier Latin

Montreal, Quebec, H2L 4E9, Canada

Location

Clinique Medicale L'Actuel

Montreal, Quebec, H2L 4P9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34416849DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMotor Activity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Nancy Mayo, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Marie-Josée Brouillette, MD

    McGill University

    PRINCIPAL INVESTIGATOR

  • Lesley Fellows, PhD/MD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adria Quigley, PhD

CONTACT

(514) 934-1934adria.quigley@mail.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nancy Mayo, Principal Investigator

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 14, 2020

Study Start

July 1, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2025

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)