The Positively Dance Pilot Program for Women Living With HIV (Dance)
Primary Purpose
Human Immunodeficiency Virus
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dance Program
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring HIV, dance, peer-led
Eligibility Criteria
Inclusion Criteria:
- Self-identify as women living with HIV
- Are over the age of 18
- Are able to speak and read English
- Are able and willing to commit to participating in dance classes 2 times a week per week for 12 weeks
- Be able to attend in person dance classes
- Meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)
Exclusion Criteria:
- Do not self-identify as a woman living with HIV
- Are under the age of 18
- Cannot speak and read English
- Cannot attend in person dance classes
- Do not meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)
Sites / Locations
- University of British ColumbiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dance Program
Control
Arm Description
Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks
Participants in the waitlist control will be assigned to a waiting list and will be invited to participate in dance classes after the intervention arm 12-week dance program has ended
Outcomes
Primary Outcome Measures
Proportion of women who accept the invitation to participate in the research study
This information will be used to understand feasibility
Number of women who initially participate in the intervention
This information will be used to understand feasibility
Proportion of women who participate in the dance classes, even after the active data collection phase is completed
To determine the extent to which women continue attending the dance classes for an additional 12 weeks, if the classes are offered for free. This information will be used to understand feasibility.
Acceptability and feasibility of the selected procedures (e.g. blood draws, questionnaires) by determining numbers who attend these sessions and complete the questionnaires
This information will be used to understand feasibility and acceptability
Adverse events that may occur during the trial
This information will be used to understand feasibility
Continued participation of the peer dance instructors
This information will be used to understand feasibility
Individual semi-structured interviews asking participants their perceptions of and experiences with the program
To determine the accessibility and feasibility of the intervention, we will conduct individual semi-structured qualitative interviews with the participants who took part in the intervention arm of the study as well as with the peer dance instructors. The women will be asked about their perceptions of and experiences with the program, including why they joined the program, what they liked and disliked about the program, what the program meant to them, how effective they thought the program had been, what barriers to participation they faced throughout the intervention, and their suggestions for future program delivery. Interviews will occur via Zoom or in-person depending on the participant's preferences and will be audio-recorded (only the audio portion of the interviews will be recorded).
Secondary Outcome Measures
Changes in whole blood telomere length
Whole blood telomere length, using the standard approach of measuring relative telomere lengths with quantitative polymerase chain reaction.
Changes in depressive symptoms measured with the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ) is the self-administered depression module of the full Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Changes in general physical and mental health measured with the 36-Item Short Form Survey
The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures relying on self-reporting. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.
Changes in social support measured with the MOS Social Support Scale
The MOS Social Support Survey measures four dimensions of functional social support. It is a 19-item multidimensional, self-administered instrument. Questions are answered on a five-point scale ranging from "none of the time" to "all of the time," with higher values indicating more support.
Changes in social connectedness measured with the Social Connectedness Scale
This scale assesses the degree to which individuals feel connected to others in their social environment. Items are scored from 1 (strongly disagree) to 6 (strongly agree). Items are summed and a higher score indicates more connectedness to others.
Changes in social cohesion measured with the Social Assurance Scale
The Social Assurance Scale is a 6 point Likert scale. Items are added up for a total score, and a higher score indicates more connectedness to others.
Changes in HbA1c
Information will be used to determine means and standard deviations for these traditional health markers
Changes in C-Reactive Protein
Information will be used to determine means and standard deviations for these traditional health markers.
Full Information
NCT ID
NCT05295797
First Posted
March 2, 2022
Last Updated
May 9, 2023
Sponsor
University of British Columbia
Collaborators
Simon Fraser University
1. Study Identification
Unique Protocol Identification Number
NCT05295797
Brief Title
The Positively Dance Pilot Program for Women Living With HIV
Acronym
Dance
Official Title
The Positively Dance Pilot Program: Examining the Feasibility of a Peer Research Associate-Led Dance Program for Women Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Simon Fraser University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Positively Dance study involves the assessment of the accessibility and feasibility of a 12-week randomized aerobic dance pilot program that will provide women living with HIV with the opportunity to take part in dance classes with women living with HIV as the dance instructors.
Detailed Description
Women living with HIV (WLWH) are at greater risk of advanced cellular aging, comorbidities, and early mortality than men living with HIV or women in the general population. WLWH face significant social and economic disadvantages which serve as barriers to accessing HIV therapy or other programming that could support their health and wellbeing. It is thus critical to identify amenable healthy aging factors to ameliorate the burden of HIV for WLWH.
Aerobic training has consistently been shown to reduce disease risk and early mortality in the general population and in people living with HIV. Immune system function partly underlies many of the cardiovascular, lung, muscular, and neural benefits of aerobic exercise. While sporadic immune activation is typical during innate and adaptive immune responses, the development and pathogenesis of non-communicable diseases are now understood to result from chronic, low-grade, systemic inflammation in the body, known as inflamm-aging as seen among people living with HIV even when their viremia is controlled by therapy. Systemic inflammation results from multiple sources, including, but not limited to, accumulation of fat and immunosenescent cells, the latter of which no longer divide but secrete damaging inflammatory cytokines. Immunosenescent cells are marked by several biomarkers, though most attention has been directed towards average telomere lengths of immune cells. Telomeres are genepoor regions located at the ends of chromosomes and are formed by hexameric 5'(TTAGGG) n3' repeats and shortened telomeres portend earlier replicative senescence - when cells no longer replicate but live on in a pro-inflammatory state - or programmed cellular death. 24 weeks of physical activity is associated with apparent reversal of the aging process of immune cells with increases in average leukocyte (i.e. immune cells) telomere lengths (LTL).
While aerobic exercise benefits people living with HIV, a recent review emphasizes that WLWH and adults from minority groups are less likely to engage in or are more likely to withdraw from standard exercise programs. Consultations with The Canadian HIV Sexual and Reproductive Health Cohort Study (CHIWOS) Advisory Board of WLWH identified and prioritized the need for interventional research to mitigate the effects of accelerated aging and decrease the risk of disease, and identified dance as a particularly exciting program to study, if made free and easily accessible.
This study will be a 12-week randomized dance pilot program. The dance classes will be led by trained peer dance instructors who are also WLHIV.
Prior to consent, participants will be screened for inclusion/exclusion criteria. Next, participants will be invited to an in-person, paid orientation session to review study objectives and discuss the pros/cons to participating in the pilot program and randomization to either a waitlist control or active study arm. After consent, participants will then be asked to complete blood draws and a pre-intervention survey.
Each dance instructor (PRA) will lead 1-2 classes (50-min/class) per week (depending on availability) for 12 weeks, with an expectation that women in the pilot's active arm have access to 2 classes per week during the first 12 weeks of active data collection. Classes will be offered in person at a local dance studio. Attendance will be taken at each dance class by throughout the 12 weeks. Participants will also have the opportunity to socialize during breaks after dance classes for as long as they wish for up to half an hour.
Following the 12 weeks of active data collection for the pilot program, all participating women will be asked to return to complete blood draws and a repeat survey to collect post-intervention data on physical activity levels, mental and physical health, and social integration. We will also conduct semi-structured interviews with all women in the active arm to learn more about their experiences in and impressions of the program.
Our 12-week program will be followed by 12 more weeks of dance classes where waitlist women are invited to join the classes. Attendance of all women will be tracked.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, dance, peer-led
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Thirty WLWH will be enrolled and randomized to the (1) group-based 12-week dance program (N=15) or (2) waitlist control (N=15) (participants in the waitlist control will be assigned to a waiting list and will be invited to participate in dance classes after the intervention arm 12-week dance program has ended).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dance Program
Arm Type
Experimental
Arm Description
Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the waitlist control will be assigned to a waiting list and will be invited to participate in dance classes after the intervention arm 12-week dance program has ended
Intervention Type
Behavioral
Intervention Name(s)
Dance Program
Intervention Description
Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks
Primary Outcome Measure Information:
Title
Proportion of women who accept the invitation to participate in the research study
Description
This information will be used to understand feasibility
Time Frame
Throughout the recruitment phase, up to 1.5 months
Title
Number of women who initially participate in the intervention
Description
This information will be used to understand feasibility
Time Frame
Week 1-12
Title
Proportion of women who participate in the dance classes, even after the active data collection phase is completed
Description
To determine the extent to which women continue attending the dance classes for an additional 12 weeks, if the classes are offered for free. This information will be used to understand feasibility.
Time Frame
Week 13-24
Title
Acceptability and feasibility of the selected procedures (e.g. blood draws, questionnaires) by determining numbers who attend these sessions and complete the questionnaires
Description
This information will be used to understand feasibility and acceptability
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Adverse events that may occur during the trial
Description
This information will be used to understand feasibility
Time Frame
Week 1-24
Title
Continued participation of the peer dance instructors
Description
This information will be used to understand feasibility
Time Frame
Week 1-24
Title
Individual semi-structured interviews asking participants their perceptions of and experiences with the program
Description
To determine the accessibility and feasibility of the intervention, we will conduct individual semi-structured qualitative interviews with the participants who took part in the intervention arm of the study as well as with the peer dance instructors. The women will be asked about their perceptions of and experiences with the program, including why they joined the program, what they liked and disliked about the program, what the program meant to them, how effective they thought the program had been, what barriers to participation they faced throughout the intervention, and their suggestions for future program delivery. Interviews will occur via Zoom or in-person depending on the participant's preferences and will be audio-recorded (only the audio portion of the interviews will be recorded).
Time Frame
Once after Week 12, up to 4 weeks after
Secondary Outcome Measure Information:
Title
Changes in whole blood telomere length
Description
Whole blood telomere length, using the standard approach of measuring relative telomere lengths with quantitative polymerase chain reaction.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in depressive symptoms measured with the Patient Health Questionnaire-9
Description
The Patient Health Questionnaire-9 (PHQ) is the self-administered depression module of the full Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in general physical and mental health measured with the 36-Item Short Form Survey
Description
The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures relying on self-reporting. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in social support measured with the MOS Social Support Scale
Description
The MOS Social Support Survey measures four dimensions of functional social support. It is a 19-item multidimensional, self-administered instrument. Questions are answered on a five-point scale ranging from "none of the time" to "all of the time," with higher values indicating more support.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in social connectedness measured with the Social Connectedness Scale
Description
This scale assesses the degree to which individuals feel connected to others in their social environment. Items are scored from 1 (strongly disagree) to 6 (strongly agree). Items are summed and a higher score indicates more connectedness to others.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in social cohesion measured with the Social Assurance Scale
Description
The Social Assurance Scale is a 6 point Likert scale. Items are added up for a total score, and a higher score indicates more connectedness to others.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in HbA1c
Description
Information will be used to determine means and standard deviations for these traditional health markers
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
Title
Changes in C-Reactive Protein
Description
Information will be used to determine means and standard deviations for these traditional health markers.
Time Frame
Baseline (Week 0) and at the end of the program (Week 13)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Woman-identified
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-identify as women living with HIV
Are over the age of 18
Are able to speak and read English
Are able and willing to commit to participating in dance classes 2 times a week per week for 12 weeks
Be able to attend in person dance classes
Meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)
Exclusion Criteria:
Do not self-identify as a woman living with HIV
Are under the age of 18
Cannot speak and read English
Cannot attend in person dance classes
Do not meet minimal risk clearance to engage in exercise (screened with the Physical Activity Readiness Questionnaire PARQ+)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Puterman, PhD
Phone
604 822 2854
Email
eli.puterman@ubc.ca
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Puterman, PhD
Phone
604 822 2854
Email
eli.puterman@ubc.ca
12. IPD Sharing Statement
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The Positively Dance Pilot Program for Women Living With HIV
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