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Drug AddictionNCT02437123

The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs

A study testing The Cedar Project mHealth intervention in people with Drug Addiction and HIV, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting. Read more about this study

Who is it for?
Ages 19 to 30 years
Conditions the study is for
Drug Addiction, HIV
What is being tested?
The Cedar Project mHealth intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteCanada
Study dates
Sep 2014to Jun 2016
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 19 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • currently enrolled in the Cedar Project
  • completed main Cedar Project Baseline questionnaire and attended at least one follow-up visit since 2009
  • had not tested positive for HIV
  • joined study in Vancouver or Prince George
  • alive at initiation of Cedar Project mHealth study

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Health Evaluation and Outcome Sciences

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting.

The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia, Canada. Indigenous collaborators and investigators, collectively known as the Cedar Project Partnership, govern the entire research process.

Read more

A stratified Zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the Cedar Project mHealth intervention with consent. Participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the WelTel platform, and support from Cedar Advocates. Those drawn from the cohort study population as the comparison group will continue on in the usual Cedar Project study under its existing informed consent with no change whatsoever to their participation in the overall study.

The main outcome is an HIV propensity score, assessed at six months and one year. Secondary outcomes include HIV risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. Primary analysis is by intention to treat.

Conditions
Drug Addiction, HIV
Being tested
The Cedar Project mHealth intervention
Keywords
mHealth, Indigenous, HIV prevention, substance use
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Cedar Project mHealth interventionBehavioural

Study groups in NCT02437123
Study groupRoleWhat they receive
The Cedar Project mHealth InterventionExperimentalThe Cedar Project mHealth intervention consists of a package of culturally-safe supports, including a mobile phone and long-distance cellular plan, weekly two-way text messaging, and support from community-based Cedar Advocates.
Receives: Behavioral: The Cedar Project mHealth intervention
Comparison groupNo interventionThe comparison group will be sampled from The Cedar Project, an ongoing cohort study of young Indigenous people who use drugs under its existing informed consent with no change whatsoever to their participation in the overall study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV propensity score

    Previous analyses of Cedar Project data have identified several factors as associated with HIV infection. These will be used to build a propensity score for HIV risk. Change in this score from baseline will be used to determine the impact of the intervention on HIV vulnerability over the prior six-month period.

    Measured: 0, 6 and 12 months

Secondary outcomes (5)

  1. HIV risk

    Several self-reported binary measures will be used to determine the impact of the intervention on HIV risk in the prior six month period, including: recent injection drug use, high frequency drug use, needle sharing, and participation in sex work.

    Measured: 0, 6 and 12 months

  2. Resilience

    Resilience, or the ability to cope with stress in the face of adversity, will be characterized using the Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC scale measures resilience via 25 items on a 5-point scale with scores ranging between 0-100, with higher scores indicating greater resilience.

    Measured: 0, 6 and 12 months

  3. Access to drug-related services

    Self-reported access to drug-related services, including opioid substitution therapy, needle exchange, safe injection facility, and drug treatment in the previous six month period will be ascertained from the main Cedar Project questionnaire. Proportions of participants reporting access to these services will be compared in the intervention and control groups. We will also determine if there are differences among treated and control groups in terms of proportion of people who tried to quit in the previous six-month period.

    Measured: 0, 6 and 12 months

  4. Connection to culture

    Connection to Indigenous culture has been hypothesized as a key protective factor for young Indigenous people who use drugs. It will be assessed using two dichotomous variables that measure cultural activity in the prior six-month period including: (1) Self-reported participation in traditional ceremonies (including: potlatch, feast, fast, burning ceremony, washing ceremony, naming ceremony, big/smoke house, rights of passage, smudge, dances, or any other traditional Indigenous ceremony); (2) frequently living by traditional culture (never/rarely vs. often/always). These variables were defined by Earl Henderson (Cree-Métis) and Violet Bozoki (Lheidli T'enneh Nation) who are Indigenous Elders, traditional knowledge keepers, and members of the Cedar Project Partnership.

    Measured: 0, 6 and 12 months

  5. Psychological distress

    The Symptom Checklist-90-R (SCL-90-R) is a 90-item self-reported symptom inventory that measures the severity of nine dimensions of psychological distress in the past three months scored on a five-point Likert scale (from not at all to extremely). Participants' SCL-90-R scores will be transformed into an average Global Severity Index ranging between 0-1.5, providing a single average measure that profiles overall degree of psychological distress.

    Measured: 0, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437123
Sponsor's protocol ID
H13-02718
Status last verified
Jul 2016
First submitted
4 May 2015
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No

Publications

  • Jongbloed K, Friedman AJ, Pearce ME, Van Der Kop ML, Thomas V, Demerais L, Pooyak S, Schechter MT, Lester RT, Spittal PM; Cedar Project Partnership. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial. Trials. 2016 Mar 9;17(1):128. doi: 10.1186/s13063-016-1250-3.

    PubMed 26957103

Questions about this trial

What is this clinical trial studying?

A study testing The Cedar Project mHealth intervention in people with Drug Addiction and HIV, run by University of British Columbia 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 0 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 28 Jan 2025. 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 propensity score (time frame: 0, 6 and 12 months). 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 NCT02437123, which also lists 1 linked publication.

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 28 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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