NCT01936857

Buprenorphine to Improve HIV Care Engagement and Outcomes

Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial (BRAVO)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Substance Related Disorders

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-03-01
• Completion: 2019-04-01
• First posted: 2013-09-06
• Last updated: 2022-05-17
• Results posted: 2020-06-24

Locations

6 sites across 1 country: Vietnam