NCT02440256

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

March 24, 2015

Last Update Submit

April 24, 2017

Conditions

Opioid Use DisorderHIV

Keywords

Cost-effectivenessOpioid substitution treatmentIntegrated careHIVHAARTTestingLinkage to careTreatment adherence

Outcome Measures

Primary Outcomes (3)

  • The HIV testing rate among those not known to be HIV positive

    24 months

  • The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART

    24 months

  • The rate of HAART adherence among those on HAART

    24 months

Study Arms (3)

Cluster 1

OTHER

Cluster 1 is the first OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the sixth month of the trial. Cluster 1 will be a 'no intervention' arm in the first 6 months of the study, and will cross-over to an experimental arm for months 6-24.

Other: Expanded HIV care in Opioid Substitution Treatment

Cluster 2

OTHER

Cluster 2 is the second OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the twelfth month of the trial. Cluster 2 will be a 'no intervention' arm in the first 12 months of the study, and will cross-over to a experimental arm for month 12-24.

Other: Expanded HIV care in Opioid Substitution Treatment

Cluster 3

OTHER

Cluster 3 is the final OST cluster (with an estimated 15-16 OST sites) to receive the 'Expanded HIV care in Opioid Substitution Treatment' intervention, to be administered during the 18th month of the trial. As such, Cluster 3 will be a 'no intervention' arm in the first 18 months of the study, and will cross-over to an experimental arm for months 18-24.

Other: Expanded HIV care in Opioid Substitution Treatment

Interventions

Expanded HIV care in Opioid Substitution TreatmentOTHER

The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care. The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals. The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.

Cluster 1Cluster 2Cluster 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Private office-based setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersTreatment Adherence and Compliance

Interventions

Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Bohdan Nosyk, PhD

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Faculty of Health Sciences, Health Economics; Endowed Chair in Health Economics HIV/AIDS

Study Record Dates

First Submitted

March 24, 2015

First Posted

May 12, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04