HIVNCT02743026
HIV and Sexually Transmitted Infection Prevention Intervention in the Northwest Territories
A study testing FOXY in people with HIV and Sexually Transmitted Diseases, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases
- What is being tested?
- FOXY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- did not participate in FOXY
- not between 13-16 years old
- don't live in the Northwest Territories
- not capable of providing informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Factor-Inwentash Faculty of Social Work
Toronto, Ontario, M5S 1V4
About this study
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
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.
Read the 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).
- Conditions
- HIV, Sexually Transmitted Diseases
- Being tested
- FOXY
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOXYBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | participants will complete the FOXY intervention Receives: Behavioral: FOXY |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV knowledge (Questionnaire)
Brief HIV Knowledge Questionnaire
Measured: 12 month follow up
Secondary outcomes (4)
Sexually Transmitted Infections knowledge (Questionnaire)
Sexually Transmitted Disease Knowledge Questionnaire
Measured: 12 month follow up
Self-esteem (scale)
Self-esteem scale
Measured: 12 month follow up
safer sex self-efficacy (Scale)
Safer Sex Self-Efficacy Scale
Measured: 12 month follow up
cultural connectedness (Scale)
Awareness of Connectedness Scale
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen Logie, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743026
- Sponsor's protocol ID
- CIHR-CBR-0000303157
- Status last verified
- Sep 2019
- First submitted
- 11 Apr 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Small numbers in towns in the North make it difficult to share data without compromising confidentiality.
Publications
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.
PubMed 22765935Lys 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.
PubMed 27697877
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02743026
- Acronym / sponsor ID
- CIHR-CBR-0000303157
- Conditions
- HIV, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: FOXYparticipants will complete the FOXY intervention |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- did not participate in FOXY
- not between 13-16 years old
- don't live in the Northwest Territories
- not capable of providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOXYThis 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. | Behavioural | Intervention |
Primary outcome
HIV knowledge (Questionnaire)
Time frame: 12 month follow up
Brief HIV Knowledge Questionnaire
4 secondary outcomes
Sexually Transmitted Infections knowledge (Questionnaire)
Time frame: 12 month follow up
Self-esteem (scale)
Time frame: 12 month follow up
safer sex self-efficacy (Scale)
Time frame: 12 month follow up
cultural connectedness (Scale)
Time frame: 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Background: PubMed 22765935Lys 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.
- Derived from this study: PubMed 27697877Lys 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.
- Individual participant dataSharing planned: No. Small numbers in towns in the North make it difficult to share data without compromising confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Logie, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOXY in people with HIV and Sexually Transmitted Diseases, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV knowledge (Questionnaire) (time frame: 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.