Clinical trial NCT05006391: Tele-Coaching Community-Based Exercise (CBE) Study
Official title: Tele-Coaching CBE Study: Evaluating the Implementation of an Online Community-Based Exercise (CBE) Intervention Using Tele-Coaching to Enhance Physical Activity Among Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: HIV
exercise
community-based exercise
tele-rehabilitation
tele-health
rehabilitation
disability
tele-coaching
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: YMCA
name: Ontario HIV Treatment Network
First posted: 2021-08-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (CBE) intervention with adults living with HIV.

Detailed description: Investigators will use the RE-AIM (Reach-Effectiveness-Adoption-Implementation-Maintenance) Framework to evaluate the tele-coaching CBE intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational levels in order to promote uptake, transferability and ultimate enhance the impact of health promotion interventions.

Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults living with HIV participate in the intervention (Reach); 2) To assess the impact of the intervention on physical activity, health, and engagement in the care cascade (Effectiveness); 3) To assess engagement in exercise for adults living with HIV over time (physical activity, adherence) (Maintenance); and 4) To evaluate the a) process (strengths, challenges, accessibility, cost, fidelity) and b) feasibility of sustainability of the implementation, from the perspective of adults living with HIV, representatives of community-based organizations (CBOs), health and fitness centres, health providers, and policy stakeholders to build capacity, products, and considerations for broader implementation (Implementation and Adoption).

Investigators will conduct a prospective longitudinal mixed methods intervention study to evaluate the implementation of an innovative online tele-coaching CBE intervention with adults living with HIV. They will use a combination of quantitative (self-reported questionnaires, fitness assessments) to assess outcomes bimonthly during the tele-coaching CBE intervention (6 months) and during a follow-up monitoring phase (6 months) to evaluate the short and long term impact of online CBE. Investigators will use a qualitative longitudinal design using interviews to assess processes and outcomes at baseline (0 months), post-intervention (6 months) and post-follow-up (12 months).

Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older) living with HIV who consider themselves medically stable and safe to engage in exercise.
* Access to technology (computer/tablet, Wi-Fi, web-cam).
* Willing to take part in a 12 month study involving thrice weekly exercise.

Exclusion Criteria:

• Not applicable.

Primary outcomes:
measure: Physical Activity
timeFrame: Weekly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 12 months (48 weeks).
Secondary outcomes:
measure: Disability
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
measure: Health
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
measure: Mental Health
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
measure: Engagement in Care
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Other outcomes:
measure: Extrinsic Contextual Factor - HIV Stigma
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
measure: Intrinsic Contextual Factor - Mastery
timeFrame: Bimonthly outcome assessment throughout the intervention phase (6 months) and follow-up monitoring phase (6 months) for a total of 13 time points.
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References: