Clinical trial NCT02440256: Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial
Official title: The Expanded HIV Care in Opioid Substitution Treatment (EHOST) Stepped-wedge, Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
HIV
Keywords: Cost-effectiveness
Opioid substitution treatment
Integrated care
HIV
HAART
Testing
Linkage to care
Treatment adherence
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: BC Centre for Excellence in HIV/AIDS
First posted: 2015-05-12
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment. The EHOST study will evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment, re-engagement and retention outcomes among individuals engaged in OST. 46 OST sites in British Columbia will be randomly allocated into three clusters. Clusters will initiative the intervention at different time points, or steps, with every cluster receiving the intervention.

Detailed description: The public health response to the HIV/AIDS epidemic has turned its focus on means of optimizing health care delivery, and re-engineering delivery systems to maximize case identification, as well as access and sustained engagement in antiretroviral treatment. Opioid Substitution Treatment (OST) provides a critical opportunity for HIV testing and linkage to antiretroviral treatment. The EHOST study is a cluster-randomized, stepped-wedge trial to evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize antiretroviral treatment re-engagement and retention outcomes among individuals engaged in OST. The study will encompass all drug treatment clinics currently admitting patients for the treatment of opioid dependence across the province of British Columbia, which are thought to treat 90% of the OST caseload. The trial will be executed over a 24-month period, with groups of clinics receiving the intervention in 6-month intervals. Evaluation of the effectiveness of the proposed intervention will be conducted entirely through existing data collection mechanisms, and focuses on three primary outcomes: (i) the HIV testing rate among those not known to be HIV positive; (ii) the rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART; and (iii) the rate of HAART continuation among those on HAART. Despite the randomized delivery of the intervention, a difference-in-differences analytical framework will be applied to adjust for potential residual heterogeneity in patient case mix, volume, and quality of care across OST clinics. Facilitated by established collaborations between key stakeholders across the province, we hypothesize that the EHOST intervention will optimize HIV testing and care within this marginalized and hard-to-reach population.

Eligibility criteria: Inclusion Criteria:

* Drug treatment clinic currently admitting patients for the treatment of opioid dependence across the province of British Columbia

Exclusion Criteria:

* Private office-based setting

Primary outcomes:
measure: The HIV testing rate among those not known to be HIV positive
timeFrame: 24 months
measure: The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART
timeFrame: 24 months
measure: The rate of HAART adherence among those on HAART
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Simon Fraser University
name: Bohdan Nosyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: