The Positively Dance Pilot Program for Women Living With HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Positively Dance Pilot Program: Examining the Feasibility of a Peer Research Associate-Led Dance Program for Women Living With HIV

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Dance Program


Participation Criteria
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Eligibility Criteria
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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+)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dance Program<br>Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks | Behavioral: Dance Program<br>* Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women who accept the invitation to participate in the research study | This information will be used to understand feasibility | Throughout the recruitment phase, up to 1.5 months | 
| Number of women who initially participate in the intervention | This information will be used to understand feasibility | Week 1-12 | 
| 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. | Week 13-24 | 
| 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 | Baseline (Week 0) and at the end of the program (Week 13) | 
| Adverse events that may occur during the trial | This information will be used to understand feasibility | Week 1-24 | 
| Continued participation of the peer dance instructors | This information will be used to understand feasibility | Week 1-24 | 
| 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). | Once after Week 12, up to 4 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in whole blood telomere length | Whole blood telomere length, using the standard approach of measuring relative telomere lengths with quantitative polymerase chain reaction. | Baseline (Week 0) and at the end of the program (Week 13) | 
| 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). | Baseline (Week 0) and at the end of the program (Week 13) | 
| 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. | Baseline (Week 0) and at the end of the program (Week 13) | 
| 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. | Baseline (Week 0) and at the end of the program (Week 13) | 
| 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. | Baseline (Week 0) and at the end of the program (Week 13) | 
| 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. | Baseline (Week 0) and at the end of the program (Week 13) | 
| Changes in HbA1c | Information will be used to determine means and standard deviations for these traditional health markers | Baseline (Week 0) and at the end of the program (Week 13) | 
| Changes in C-Reactive Protein | Information will be used to determine means and standard deviations for these traditional health markers. | Baseline (Week 0) and at the end of the program (Week 13) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, dance, peer-led