Buprenorphine to Improve HIV Care Engagement and Outcomes

PHASE4CompletedINTERVENTIONAL
Enrollment

281

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

March 31, 2019

Study Completion Date

April 30, 2019

Conditions
HIVSubstance Related Disorders
Interventions
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.

Trial Locations (6)

Unknown

Bac Giang PAC OPC, Bắc Giang

Dong Da OPC, Hanoi

Hoang Mai HIV Clinic, Hanoi

Long Bien, Hanoi

Tu Liem, Hanoi

Thanh Hoa PAC OPC, Thanh Hóa

All Listed Sponsors
collaborator

Hanoi Medical University

OTHER

collaborator

Hennepin Healthcare Research Institute

OTHER

lead

Oregon Health and Science University

OTHER

NCT01936857 - Buprenorphine to Improve HIV Care Engagement and Outcomes | Biotech Hunter | Biotech Hunter