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

HIV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437123
• Other study ID #: H13-02718
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: July 14, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Addiction
• HIV
• Substance-Related Disorders

Intervention

Behavioral:
• The Cedar Project mHealth intervention

Locations

Country	Name	City	State
Canada	Centre for Health Evaluation and Outcome Sciences	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	HIV risk	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	No
Secondary	Resilience	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	No
Secondary	Access to drug-related services	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	No
Secondary	Connection to culture	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	No
Secondary	Psychological distress	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	No