The Positively Dance Pilot Program for Women Living With HIV

Human Immunodeficiency Virus Clinical Trial

— Dance  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295797
• Other study ID #: H20-03483
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Eli Puterman, PhD
• Phone: 604 822 2854
• Email: eli.puterman[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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+)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• Dance Program
Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Simon Fraser University

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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Burchell AN, Raboud J, Donelle J, Loutfy MR, Rourke SB, Rogers T, Rosenes R, Liddy C, Kendall CE. Cause-specific mortality among HIV-infected people in Ontario, 1995-2014: a population-based retrospective cohort study. CMAJ Open. 2019 Jan 8;7(1):E1-E7. doi: 10.9778/cmajo.20180159. Print 2019 Jan-Mar. — View Citation

Campisi J, d'Adda di Fagagna F. Cellular senescence: when bad things happen to good cells. Nat Rev Mol Cell Biol. 2007 Sep;8(9):729-40. doi: 10.1038/nrm2233. — View Citation

De Francesco D, Wit FW, Burkle A, Oehlke S, Kootstra NA, Winston A, Franceschi C, Garagnani P, Pirazzini C, Libert C, Grune T, Weber D, Jansen EHJM, Sabin CA, Reiss P; the Co-morBidity in Relation to AIDS (COBRA) Collaboration. Do people living with HIV experience greater age advancement than their HIV-negative counterparts? AIDS. 2019 Feb 1;33(2):259-268. doi: 10.1097/QAD.0000000000002063. — View Citation

Franceschi C, Garagnani P, Parini P, Giuliani C, Santoro A. Inflammaging: a new immune-metabolic viewpoint for age-related diseases. Nat Rev Endocrinol. 2018 Oct;14(10):576-590. doi: 10.1038/s41574-018-0059-4. — View Citation

Heissel A, Zech P, Rapp MA, Schuch FB, Lawrence JB, Kangas M, Heinzel S. Effects of exercise on depression and anxiety in persons living with HIV: A meta-analysis. J Psychosom Res. 2019 Nov;126:109823. doi: 10.1016/j.jpsychores.2019.109823. Epub 2019 Sep 2. — View Citation

Hogg RS, Eyawo O, Collins AB, Zhang W, Jabbari S, Hull MW, Lima VD, Ahmed T, Kendall CE, Althoff KN, Justice AC, Barrios R, Shoveller J, Montaner JSG; Comparative Outcomes And Service Utilization Trends (COAST) study. Health-adjusted life expectancy in HIV-positive and HIV-negative men and women in British Columbia, Canada: a population-based observational cohort study. Lancet HIV. 2017 Jun;4(6):e270-e276. doi: 10.1016/S2352-3018(17)30029-2. Epub 2017 Mar 3. — View Citation

Keating SM, Golub ET, Nowicki M, Young M, Anastos K, Crystal H, Cohen MH, Zhang J, Greenblatt RM, Desai S, Wu S, Landay AL, Gange SJ, Norris PJ; Women's Interagency HIV Study. The effect of HIV infection and HAART on inflammatory biomarkers in a population-based cohort of women. AIDS. 2011 Sep 24;25(15):1823-32. doi: 10.1097/QAD.0b013e3283489d1f. — View Citation

Kendall CE, Wong J, Taljaard M, Glazier RH, Hogg W, Younger J, Manuel DG. A cross-sectional, population-based study measuring comorbidity among people living with HIV in Ontario. BMC Public Health. 2014 Feb 13;14:161. doi: 10.1186/1471-2458-14-161. — View Citation

Moyzis RK, Buckingham JM, Cram LS, Dani M, Deaven LL, Jones MD, Meyne J, Ratliff RL, Wu JR. A highly conserved repetitive DNA sequence, (TTAGGG)n, present at the telomeres of human chromosomes. Proc Natl Acad Sci U S A. 1988 Sep;85(18):6622-6. doi: 10.1073/pnas.85.18.6622. — View Citation

O'Brien KK, Tynan AM, Nixon SA, Glazier RH. Effectiveness of aerobic exercise for adults living with HIV: systematic review and meta-analysis using the Cochrane Collaboration protocol. BMC Infect Dis. 2016 Apr 26;16:182. doi: 10.1186/s12879-016-1478-2. — View Citation

Patterson S, Cescon A, Samji H, Chan K, Zhang W, Raboud J, Burchell AN, Cooper C, Klein MB, Rourke SB, Loutfy MR, Machouf N, Montaner JS, Tsoukas C, Hogg RS; CANOC collaboration. Life expectancy of HIV-positive individuals on combination antiretroviral therapy in Canada. BMC Infect Dis. 2015 Jul 17;15:274. doi: 10.1186/s12879-015-0969-x. — View Citation

Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581. — View Citation

Scully EP. Sex Differences in HIV Infection. Curr HIV/AIDS Rep. 2018 Apr;15(2):136-146. doi: 10.1007/s11904-018-0383-2. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of women who initially participate in the intervention	This information will be used to understand feasibility	Week 1-12
Primary	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
Primary	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)
Primary	Adverse events that may occur during the trial	This information will be used to understand feasibility	Week 1-24
Primary	Continued participation of the peer dance instructors	This information will be used to understand feasibility	Week 1-24
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)