- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02743026
HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5S 1V4
- University of Toronto, Factor-Inwentash Faculty of Social Work
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Intervention
participants will complete the FOXY intervention
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
HIV knowledge (Questionnaire)
Tidsram: 12 month follow up
|
Brief HIV Knowledge Questionnaire
|
12 month follow up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sexually Transmitted Infections knowledge (Questionnaire)
Tidsram: 12 month follow up
|
Sexually Transmitted Disease Knowledge Questionnaire
|
12 month follow up
|
Self-esteem (scale)
Tidsram: 12 month follow up
|
Self-esteem scale
|
12 month follow up
|
safer sex self-efficacy (Scale)
Tidsram: 12 month follow up
|
Safer Sex Self-Efficacy Scale
|
12 month follow up
|
cultural connectedness (Scale)
Tidsram: 12 month follow up
|
Awareness of Connectedness Scale
|
12 month follow up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Carmen Logie, PhD, University of Toronto
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CIHR-CBR-0000303157
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på FOXY
-
WntResearch ABAvslutadMetastaserad bröstcancer | Metastaserad prostatacancer | Metastaserande tjocktarmscancerDanmark, Storbritannien
-
WntResearch ABAvslutadKolorektal cancer | Prostatacancer | Metastaserad bröstcancerDanmark
-
WntResearch ABInstitut Català d'Oncologia; SMS-Oncology BV; SAGA diagnostics AB; Unilabs A/S och andra samarbetspartnersAktiv, inte rekryterande