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HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

Primary Purpose

HIV, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FOXY
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

13 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Toronto, Factor-Inwentash Faculty of Social Work

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

participants will complete the FOXY intervention

Outcomes

Primary Outcome Measures

HIV knowledge (Questionnaire)
Brief HIV Knowledge Questionnaire

Secondary Outcome Measures

Sexually Transmitted Infections knowledge (Questionnaire)
Sexually Transmitted Disease Knowledge Questionnaire
Self-esteem (scale)
Self-esteem scale
safer sex self-efficacy (Scale)
Safer Sex Self-Efficacy Scale
cultural connectedness (Scale)
Awareness of Connectedness Scale

Full Information

First Posted
April 11, 2016
Last Updated
September 16, 2019
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02743026
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
participants will complete the FOXY intervention
Intervention Type
Behavioral
Intervention Name(s)
FOXY
Intervention Description
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 Outcome Measure Information:
Title
HIV knowledge (Questionnaire)
Description
Brief HIV Knowledge Questionnaire
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
Sexually Transmitted Infections knowledge (Questionnaire)
Description
Sexually Transmitted Disease Knowledge Questionnaire
Time Frame
12 month follow up
Title
Self-esteem (scale)
Description
Self-esteem scale
Time Frame
12 month follow up
Title
safer sex self-efficacy (Scale)
Description
Safer Sex Self-Efficacy Scale
Time Frame
12 month follow up
Title
cultural connectedness (Scale)
Description
Awareness of Connectedness Scale
Time Frame
12 month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Logie, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto, Factor-Inwentash Faculty of Social Work
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1V4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Small numbers in towns in the North make it difficult to share data without compromising confidentiality.
Citations:
PubMed Identifier
22765935
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.
Results Reference
background
PubMed Identifier
27697877
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.
Results Reference
derived

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HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories

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