NCT02437123

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 28, 2025

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

May 4, 2015

Last Update Submit

January 27, 2025

Conditions

Drug AddictionHIV

Keywords

mHealthIndigenousHIV preventionsubstance use

Outcome Measures

Primary Outcomes (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.

    0, 6 and 12 months

Secondary Outcomes (5)

  • HIV risk

    0, 6 and 12 months

  • Resilience

    0, 6 and 12 months

  • Access to drug-related services

    0, 6 and 12 months

  • Connection to culture

    0, 6 and 12 months

  • Psychological distress

    0, 6 and 12 months

Study Arms (2)

The Cedar Project mHealth Intervention

EXPERIMENTAL

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

Comparison group

NO INTERVENTION

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.

Interventions

The Cedar Project mHealth interventionBEHAVIORAL
The Cedar Project mHealth Intervention

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Evaluation and Outcome Sciences

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26957103DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 7, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 28, 2025

Record last verified: 2016-07

Locations

CA(1)