NCT01936857|CompletedPhase 4ResultsDMC
Buprenorphine to Improve HIV Care Engagement and Outcomes
BRAVO
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Sponsor study identifier
Secondary identifiers
NIH
interventional
281
1 country
6
Study Start
July 2015
Actual (reported)Primary Completion
March 2019
Actual (reported)Study Completion
April 2019
Actual (reported)The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 3, 2013
Actual (reported)September 6, 2013
Actual (reported)July 2015
Actual (reported)March 2019
Actual (reported)April 2019
Actual (reported)June 24, 2020
Actual (reported)Number of Participants With HIV Viral Suppression
HIV-1 RNA \< 200 copies/mL
12 months
Participants With Heroin Use (Urine Drug Screen)
12 months
Participants With Heroin Use (Self-report)
12 months
Number of Participants in Receipt of Antiretroviral Therapy (ART)
12 months
Number of Participants in Retention in HIV Care
12 months
Office based treatment of opioid dependence with buprenorphine/naloxone
Referral to methadone maintenance therapy for treatment of opioid dependence.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Buprenorphine/naloxone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTreatment programme
Methadone Maintenance Therapy
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordBac Giang PAC OPC
Bắc Giang, Vietnam
Dong Da OPC
Hanoi, Vietnam
Hoang Mai HIV Clinic
Hanoi, Vietnam
Long Bien
Hanoi, Vietnam
Tu Liem
Hanoi, Vietnam
Thanh Hoa PAC OPC
Thanh Hóa, Vietnam
Edsall A, Hoffman KA, Thuy DT, Mai PP, Hang NT, Khuyen TT, Trang NT, Kunkel LE, Giang LM, Korthuis PT. Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study. BMC Public Health. 2021 Sep 22;21(1):1718. doi: 10.1186/s12889-021-11783-9.
Korthuis PT, King C, Cook RR, Khuyen TT, Kunkel LE, Bart G, Nguyen T, Thuy DT, Bielavitz S, Nguyen DB, Tam NTM, Giang LM. HIV clinic-based buprenorphine plus naloxone versus referral for methadone maintenance therapy for treatment of opioid use disorder in HIV clinics in Vietnam (BRAVO): an open-label, randomised, non-inferiority trial. Lancet HIV. 2021 Feb;8(2):e67-e76. doi: 10.1016/S2352-3018(20)30302-7.
Philip T Korthuis, MD, MPH
Oregon Health and Science University
281 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2013
First Posted
September 6, 2013
Study Start
July 2015
Actual (reported)Starting Treatment With Agonist Replacement Therapies (START)
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.
Contact the study team to confirm eligibility.
Primary Completion
March 2019
Actual (reported)Study Completion
April 2019
Actual (reported)Last Updated
May 17, 2022
Results First Posted
June 24, 2020
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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