HIV Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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