NCT05295797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

March 2, 2022

Last Update Submit

May 9, 2023

Conditions

Keywords

HIVdancepeer-led

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (8)

  • Changes in whole blood telomere length

    Baseline (Week 0) and at the end of the program (Week 13)

  • Changes in depressive symptoms measured with the Patient Health Questionnaire-9

    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

    Baseline (Week 0) and at the end of the program (Week 13)

  • Changes in social support measured with the MOS Social Support Scale

    Baseline (Week 0) and at the end of the program (Week 13)

  • Changes in social connectedness measured with the Social Connectedness Scale

    Baseline (Week 0) and at the end of the program (Week 13)

  • +3 more secondary outcomes

Study Arms (2)

Dance Program

EXPERIMENTAL

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

Behavioral: Dance Program

Control

NO INTERVENTION

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

Interventions

Dance ProgramBEHAVIORAL

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

Dance Program

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWoman-identified
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+)

You may not qualify if:

  • 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+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

RECRUITING

Related Publications (14)

  • 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.

    PMID: 30622108BACKGROUND
  • 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.

    PMID: 28262574BACKGROUND
  • Scully EP. Sex Differences in HIV Infection. Curr HIV/AIDS Rep. 2018 Apr;15(2):136-146. doi: 10.1007/s11904-018-0383-2.

    PMID: 29504062BACKGROUND
  • 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.

    PMID: 24524286BACKGROUND
  • 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.

    PMID: 26183704BACKGROUND
  • 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.

    PMID: 31518734BACKGROUND
  • 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.

    PMID: 26606383BACKGROUND
  • 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.

    PMID: 27112335BACKGROUND
  • 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.

    PMID: 30046148BACKGROUND
  • 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.

    PMID: 30325781BACKGROUND
  • 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.

    PMID: 21572306BACKGROUND
  • Blackburn EH, Gall JG. A tandemly repeated sequence at the termini of the extrachromosomal ribosomal RNA genes in Tetrahymena. J Mol Biol. 1978 Mar 25;120(1):33-53. doi: 10.1016/0022-2836(78)90294-2. No abstract available.

    PMID: 642006BACKGROUND
  • 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.

    PMID: 3413114BACKGROUND
  • 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.

    PMID: 17667954BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Eli Puterman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 25, 2022

Study Start

May 1, 2022

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations