The Positively Dance Pilot Program for Women Living With HIV
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: Dance Program
- Registration Number
- NCT05295797
- Lead Sponsor
- University of British Columbia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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+)
- 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+)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dance Program Dance Program Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks
- Primary Outcome Measures
Name Time Method Individual semi-structured interviews asking participants their perceptions of and experiences with the program Once after Week 12, up to 4 weeks after 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).
Proportion of women who accept the invitation to participate in the research study Throughout the recruitment phase, up to 1.5 months This information will be used to understand feasibility
Number of women who initially participate in the intervention Week 1-12 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 Week 13-24 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.
Continued participation of the peer dance instructors Week 1-24 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 Baseline (Week 0) and at the end of the program (Week 13) This information will be used to understand feasibility and acceptability
Adverse events that may occur during the trial Week 1-24 This information will be used to understand feasibility
- Secondary Outcome Measures
Name Time Method Changes in social connectedness measured with the Social Connectedness Scale Baseline (Week 0) and at the end of the program (Week 13) 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 HbA1c Baseline (Week 0) and at the end of the program (Week 13) Information will be used to determine means and standard deviations for these traditional health markers
Changes in depressive symptoms measured with the Patient Health Questionnaire-9 Baseline (Week 0) and at the end of the program (Week 13) 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 social support measured with the MOS Social Support Scale Baseline (Week 0) and at the end of the program (Week 13) 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 general physical and mental health measured with the 36-Item Short Form Survey Baseline (Week 0) and at the end of the program (Week 13) 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 cohesion measured with the Social Assurance Scale Baseline (Week 0) and at the end of the program (Week 13) 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 C-Reactive Protein Baseline (Week 0) and at the end of the program (Week 13) Information will be used to determine means and standard deviations for these traditional health markers.
Changes in whole blood telomere length Baseline (Week 0) and at the end of the program (Week 13) Whole blood telomere length, using the standard approach of measuring relative telomere lengths with quantitative polymerase chain reaction.
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada