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

January 27, 2025 updated by: University of British Columbia

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Centre for Health Evaluation and Outcome Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Cedar Project mHealth Intervention
The 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.
Behavioral: The Cedar Project mHealth intervention
No Intervention: Comparison group
The 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HIV propensity score
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV risk
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months
Resilience
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months
Access to drug-related services
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months
Connection to culture
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months
Psychological distress
Time Frame: 0, 6 and 12 months
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.
0, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H13-02718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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