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Status
Ongoing
Phase
Demo Project
Open Label
Principal Investigator(s)
Steve Shoptaw
Objective
HPTN 094 or “INTEGRA” is a vanguard study to determine the efficacy of using a mobile health unit to provide integrated health services - particularly medication for opioid use disorder (OUD) and medication for HIV treatment or prevention - to people with OUD who inject drugs in five U.S. cities.
The purpose of this study is to determine the efficacy of using a mobile health delivery unit (“mobile unit”) to deliver “one stop” integrated health services – particularly medication for opioid use disorder (MOUD) and medication for HIV treatment and prevention – to people who inject drugs (PWID) with opioid use disorder (OUD) to improve uptake and use of MOUD, and uptake and use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). The intervention arm receiving health services in the mobile unit will be supported by peer navigation. An active control arm will receive peer navigation to health services available at community-based agencies. Impact (cost-effectiveness, mathematical modeling) and implementation factors (mixed methods to identify barriers and facilitators of the interventions) will contextualize findings from the efficacy analysis. The impact of the COVID-19 epidemic in the study population will also be assessed.
See here for more details on the HPTN study website.
Last updated June 10, 2022
Prevention Option(s)
General
PrEP
Treatment
Study Design
Controlled
Randomized
Open label
Arms and Assigned Interventions
Description
Intervention Arm: Participants will receive “one stop” health services in a mobile health unit and peer navigation from a peer recovery coach for 26 weeks. During this time, the mobile unit will provide the participant with primary care services including medication for opioid use disorder (MOUD), ART, PrEP and STIs as well as harm reduction services, and screening and referral for hepatitis, mental health issues, and other medical conditions. After 26 weeks, participants will be referred to health services available in the community.
ARMs
Experimental
Description
Active Control Arm: Participants who are randomized to the active control arm will receive peer navigation to health services available in the community.
ARMs
Active Comparator
Official Code
Trial Sponsors
NIAID (DAIDS ID: 38715)
June 2021
Enrollment
860
18
Years
60
Years
Population
HIV positive
Injecting drug users
Men
Women
Sites
Bronx Prevention Center
Bronx, New York
United States of America
George Washington University CRS
Washington, District of Columbia
United States of America
Houston AIDS Research Team CRS
Houston, Texas
United States of America
Penn Prevention CRS
Philadelphia, Pennsylvania
United States of America
UCLA Vine Street Clinic
Los Angeles, California
United States of America