NCT02743026

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

April 11, 2016

Last Update Submit

September 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • HIV knowledge (Questionnaire)

    Brief HIV Knowledge Questionnaire

    12 month follow up

Secondary Outcomes (4)

  • Sexually Transmitted Infections knowledge (Questionnaire)

    12 month follow up

  • Self-esteem (scale)

    12 month follow up

  • safer sex self-efficacy (Scale)

    12 month follow up

  • cultural connectedness (Scale)

    12 month follow up

Study Arms (1)

Intervention

EXPERIMENTAL

participants will complete the FOXY intervention

Behavioral: FOXY

Interventions

FOXYBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • did not participate in FOXY
  • not between 13-16 years old
  • don't live in the Northwest Territories
  • not capable of providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto, Factor-Inwentash Faculty of Social Work

Toronto, Ontario, M5S 1V4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 22765935BACKGROUND
  • 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.

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

6-fluoro-6-desoxyoxymorphone

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carmen Logie, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 19, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Small numbers in towns in the North make it difficult to share data without compromising confidentiality.

Locations