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HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Carmen Logie, MSW, PhD, University of Toronto
Sponsor:
Information provided by (Responsible Party):
Carmen Logie, MSW, PhD, University of Toronto
ClinicalTrials.gov Identifier:
NCT02743026
First received: April 11, 2016
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV and sexually transmitted infections (STI) prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada. This is a multi-centre non-randomised cohort pilot study using a pre-test/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in eighteen communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the intervention, and a 12-month follow up.

Condition Intervention
HIV Sexually Transmitted Diseases Behavioral: FOXY

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Arts-based HIV and Sexually Transmitted Infection Prevention Intervention With Northern and Indigenous Youth in the Northwest Territories: Study Protocol for a Non-randomised Cohort Pilot Study

Resource links provided by NLM:


Further study details as provided by Carmen Logie, MSW, PhD, University of Toronto:

Primary Outcome Measures:
  • HIV knowledge (Questionnaire) [ Time Frame: 12 month follow up ]
    Brief HIV Knowledge Questionnaire


Secondary Outcome Measures:
  • Sexually Transmitted Infections knowledge (Questionnaire) [ Time Frame: 12 month follow up ]
    Sexually Transmitted Disease Knowledge Questionnaire

  • Self-esteem (scale) [ Time Frame: 12 month follow up ]
    Self-esteem scale

  • safer sex self-efficacy (Scale) [ Time Frame: 12 month follow up ]
    Safer Sex Self-Efficacy Scale

  • cultural connectedness (Scale) [ Time Frame: 12 month follow up ]
    Awareness of Connectedness Scale


Estimated Enrollment: 150
Study Start Date: October 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
participants will complete the FOXY intervention
Behavioral: FOXY
This study will evaluate an arts-based HIV prevention program, Fostering Open eXpression among Youth (FOXY) in the NWT, Canada that works with Northern and Indigenous youth to promote sexual health and reduce exposure to HIV/STI. FOXY explores sexual health, HIV/STIs, sexuality and healthy relationships with young women in the NWT. The program's goal is to use arts-based methods and peers to facilitate education and foster more open expression and communication regarding sexual health and sexuality. FOXY uses arts-based approaches in program delivery; for example, drama techniques are used to facilitate discussion and learning about healthy relationships and making positive choices in realistic sexual scenarios.

Detailed Description:

Introduction: Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Current and historical contexts of colonization and racism, disconnection from culture and land, as well as intergenerational trauma resulting from the legacy of residential schools are social drivers that elevate exposure to HIV among Indigenous peoples. Peer-education and arts-based interventions are increasingly used for HIV prevention with youth. Yet limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada.

Methods & Analysis: This is a multi-centre non-randomised cohort pilot study using a pre-test/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in eighteen communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pre-test, post-test survey directly following the intervention, and a 12-month follow up. The primary outcome is new or enhanced HIV knowledge, and secondary outcomes to include: new or enhanced STI knowledge, and increased self-esteem, resilience, empowerment, safer sex self-efficacy, and cultural connectedness. Mixed effects regression analyses will be conducted to evaluate pre- and post-test differences in outcome measurement scores.

Ethics and Dissemination: This study has received approval from the HIV Research Ethics Board at the University of Toronto (REB: 31602).

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participating in FOXY
  • self-identify as a woman
  • live in the Northwest Territories
  • between the ages of 13 and 16 years of age
  • capable of providing informed consent

Exclusion Criteria:

  • did not participate in FOXY
  • not between 13-16 years old
  • don't live in the Northwest Territories
  • not capable of providing informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02743026

Contacts
Contact: Carmen Logie, PhD 647 454 4203 carmen.logie@utoronto.ca

Locations
Canada, Ontario
University of Toronto, Factor-Inwentash Faculty of Social Work Recruiting
Toronto, Ontario, Canada, M5S 1V4
Contact: Carmen Logie, PhD    647 454 4203    carmen.logie@utoronto.ca   
Principal Investigator: Carmen Logie, PhD         
Sub-Investigator: Candice Lys, MA         
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Carmen Logie, PhD University of Toronto
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmen Logie, MSW, PhD, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02743026     History of Changes
Other Study ID Numbers: CIHR-CBR-0000303157
Study First Received: April 11, 2016
Last Updated: April 22, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Small numbers in towns in the North make it difficult to share data without compromising confidentiality.

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 22, 2017