Clinical trial NCT02437123: The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Addiction
HIV
Keywords: mHealth
Indigenous
HIV prevention
substance use
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-05-07
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: HIV propensity score
timeFrame: 0, 6 and 12 months
Secondary outcomes:
measure: HIV risk
timeFrame: 0, 6 and 12 months
measure: Resilience
timeFrame: 0, 6 and 12 months
measure: Access to drug-related services
timeFrame: 0, 6 and 12 months
measure: Connection to culture
timeFrame: 0, 6 and 12 months
measure: Psychological distress
timeFrame: 0, 6 and 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Health Evaluation and Outcome Sciences
state: British Columbia
Study officials:
References:
citation: 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.