Clinical Trials Directory

Trials / Completed

CompletedNCT02437123

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
19 Years – 30 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALThe Cedar Project mHealth intervention

Timeline

Start date
2014-09-01
Primary completion
2016-06-01
Completion
2016-06-01
First posted
2015-05-07
Last updated
2025-01-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02437123. Inclusion in this directory is not an endorsement.