Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)
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|ClinicalTrials.gov Identifier: NCT01936857|
Recruitment Status : Recruiting
First Posted : September 6, 2013
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Substance Related Disorders||Drug: Buprenorphine/naloxone Drug: Methadone Maintenance Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Office based treatment of opioid dependence with buprenorphine/naloxone
Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
Other Name: Suboxone
Active Comparator: Methadone Maintenance Therapy
Referral to methadone maintenance therapy for treatment of opioid dependence.
Drug: Methadone Maintenance Therapy
Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
- HIV Viral Suppression [ Time Frame: 12 months ]HIV-1 RNA < 200 copies/mL
- Receipt of Antiretroviral Therapy (ART) [ Time Frame: 12 months ]Initiation of and retention on treatment with antiretroviral medications.
- Retention in HIV care [ Time Frame: 12 months ]Attendance at scheduled HIV clinic visits.
- Heroin use [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936857
|Contact: Philip T Korthuis, MD, MPHfirstname.lastname@example.org|
|Contact: Giang M Le, MDemail@example.com|
|Bac Giang PAC OPC||Active, not recruiting|
|Bac Giang, Vietnam|
|Dong Da OPC||Recruiting|
|Hoang Mai HIV Clinic||Recruiting|
|Thanh Hoa PAC OPC||Active, not recruiting|
|Thanh Hoa, Vietnam|
|Principal Investigator:||Philip T Korthuis, MD, MPH||Oregon Health and Science University|