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Completed

NCT Number: NCT02743026

HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

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.

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Key information

Age range

13 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto, Factor-Inwentash Faculty of Social Work

Toronto, Ontario, M5S 1V4, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOXY

Behavioral

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.

Primary outcomes

  1. HIV knowledge (Questionnaire)

    Time frame: 12 month follow up

    Brief HIV Knowledge Questionnaire

Secondary outcomes

  1. Sexually Transmitted Infections knowledge (Questionnaire)

    Time frame: 12 month follow up

    Sexually Transmitted Disease Knowledge Questionnaire

  2. Self-esteem (scale)

    Time frame: 12 month follow up

    Self-esteem scale

  3. safer sex self-efficacy (Scale)

    Time frame: 12 month follow up

    Safer Sex Self-Efficacy Scale

  4. cultural connectedness (Scale)

    Time frame: 12 month follow up

    Awareness of Connectedness Scale

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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