Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial

HIV Clinical Trial

— EHOST  

Official title:

The Expanded HIV Care in Opioid Substitution Treatment (EHOST) Stepped-wedge, Cluster-randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440256
• Other study ID #: MOP313184
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: April 24, 2017
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Opioid Use Disorder

Intervention

Other:
• Expanded HIV care in Opioid Substitution Treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Simon Fraser University	BC Centre for Excellence in HIV/AIDS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The HIV testing rate among those not known to be HIV positive		24 months
Primary	The rate of Highly Active Antiretroviral (HAART) initiation among those not on HAART		24 months
Primary	The rate of HAART adherence among those on HAART		24 months