HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743026
• Other study ID #: CIHR-CBR-0000303157
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2019
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 30, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases

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.

Locations

Country	Name	City	State
Canada	University of Toronto, Factor-Inwentash Faculty of Social Work	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lys C, Reading C. Coming of age: how young women in the Northwest Territories understand the barriers and facilitators to positive, empowered, and safer sexual health. Int J Circumpolar Health. 2012 Jul 2;71:18957. doi: 10.3402/ijch.v71i0.18957. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV knowledge (Questionnaire)	Brief HIV Knowledge Questionnaire	12 month follow up
Secondary	Sexually Transmitted Infections knowledge (Questionnaire)	Sexually Transmitted Disease Knowledge Questionnaire	12 month follow up
Secondary	Self-esteem (scale)	Self-esteem scale	12 month follow up
Secondary	safer sex self-efficacy (Scale)	Safer Sex Self-Efficacy Scale	12 month follow up
Secondary	cultural connectedness (Scale)	Awareness of Connectedness Scale	12 month follow up