Clinical trial NCT01936857: Buprenorphine to Improve HIV Care Engagement and Outcomes
Official title: Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Substance Related Disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Hanoi Medical University
name: Hennepin Healthcare Research Institute
First posted: 2013-09-06
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
* Urine drug screen positive for opioids
* Interested in receiving treatment for opioid dependence
* Age at least 18 years old
* Willing to practice an effective method of birth control, if female

Exclusion Criteria:

* Known hypersensitivity to buprenorphine or naloxone
* aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) \> 5x upper limit
* Currently pregnant or breastfeeding
* Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
* Methadone maintenance treatment within 30 days of consent

Primary outcomes:
measure: Number of Participants With HIV Viral Suppression
timeFrame: 12 months
measure: Participants With Heroin Use (Urine Drug Screen)
timeFrame: 12 months
measure: Participants With Heroin Use (Self-report)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants in Receipt of Antiretroviral Therapy (ART)
timeFrame: 12 months
measure: Number of Participants in Retention in HIV Care
timeFrame: 12 months
Other outcomes:
Locations:
city: Bac Giang
country: Vietnam
facility: Bac Giang PAC OPC
city: Hanoi
country: Vietnam
facility: Dong Da OPC
city: Hanoi
country: Vietnam
facility: Hoang Mai HIV Clinic
city: Hanoi
country: Vietnam
facility: Long Bien
city: Hanoi
country: Vietnam
facility: Tu Liem
city: Thanh Hoa
country: Vietnam
facility: Thanh Hoa PAC OPC
Study officials:
affiliation: Oregon Health and Science University
name: Philip T Korthuis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.