HPTN 094/ INTEGRA
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):PrEP, Treatment U=U
Study Design:Controlled, Open label, Randomized
Official Code:
NCT04804072
Trial Sponsors:
NIAID (DAIDS ID: 38715)
Start Date
End Date
June 9, 2021
none
Enrollment:860
Age range:
18 Years ↔
60 Years
Population:Cisgender Men, Cisgender Women, Injecting drug users, People Living with HIV