Clinical trial NCT02743026: HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Diseases
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 199
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: HIV knowledge (Questionnaire)
timeFrame: 12 month follow up
Secondary outcomes:
measure: Sexually Transmitted Infections knowledge (Questionnaire)
timeFrame: 12 month follow up
measure: Self-esteem (scale)
timeFrame: 12 month follow up
measure: safer sex self-efficacy (Scale)
timeFrame: 12 month follow up
measure: cultural connectedness (Scale)
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Factor-Inwentash Faculty of Social Work
state: Ontario
Study officials:
affiliation: University of Toronto
name: Carmen Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lys C, Logie CH, MacNeill N, Loppie C, Dias LV, Masching R, Gesink D. Arts-based HIV and STI prevention intervention with Northern and Indigenous youth in the Northwest Territories: study protocol for a non-randomised cohort pilot study. BMJ Open. 2016 Oct 3;6(10):e012399. doi: 10.1136/bmjopen-2016-012399.