The Positively Dance Pilot Program for Women Living With HIV

NCT ID: NCT05295797

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-09-01

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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dance Program

Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks

Group Type EXPERIMENTAL

Dance Program

Intervention Type BEHAVIORAL

Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dance Program

Participants will take 2 in person dance classes led by peer dance instructors per week for 12 weeks

Intervention Type BEHAVIORAL

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+)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Simon Fraser University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Eli Puterman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Eli Puterman, PhD

Role: CONTACT

604 822 2854

Facility Contacts

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Eli Puterman, PhD

Role: primary

604 822 2854

References

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Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
PMID: 30046148 (View on PubMed)

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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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H20-03483

Identifier Type: -

Identifier Source: org_study_id

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