INTEGRA: A Vanguard Study of Integrated Strategies for Linking Persons with Opioid Use Disorder to Care and Prevention for Addiction, HIV, HCV and Primary Care
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.
A two-arm, individually randomized, controlled, open label study
HIV-positive and HIV-negative PWID with OUD not receiving MOUD
A total of 860 participants allotted in a 1:1 ratio to intervention and active control arms, with targets of a minimum 25% women and 25% participants under 30 years of age, with approximately 460 HIV positive and 400 HIV-negative participants.
Approximately three and a half years total with individual participants on study for approximately 52 weeks (26 weeks receiving the intervention or peer navigation and then an evaluation for durability of effect at the end of 52 weeks).
All potential study participants will provide biological samples and self-reported data via interview in the mobile unit at Screening and Enrollment Visits. Samples will be tested for HIV, hepatitis A (HAV), B (HBV) and C (HCV) and sexually transmitted infections (STIs). At the Enrollment Visit, participants who meet all inclusion and no exclusion criteria will be randomized to the intervention or active control arm and will receive harm reduction services and empiric treatment for STIs if symptomatic. Participants will also be assessed for COVID-19 at study visits; participants with suspected COVID-19 will be referred for further evaluation, care and/or treatment, as available.
Intervention Arm: Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. The integrated health services in the mobile unit will include:
• MOUD and harm reduction services for OUD
• HIV testing
• HIV treatment for HIV-positive participants not already in care
• PrEP for HIV-negative participants
• Testing and referral for vaccination or treatment for HAV and HBV
• Testing and referral for treatment for HCV
• STI testing and treatment
• Primary care
• Harm reduction services
Peer navigation in the intervention arm will coordinate and facilitate integrated care in the mobile unit through 26 weeks. As participants become established in care, navigation will help transition participants to community-based services by 26 weeks after randomization.
Active Control Arm: Participants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
All participants (both arms) will have study visits at 26 and 52 weeks for evaluation of study endpoints.
To evaluate whether 26 weeks of “one stop” integrated health services delivered in a mobile unit, supported by peer navigation, improves use of MOUD, increases rates of viral suppression among HIV-positive individuals, and increases use of PrEP among HIV-negative individuals, as measured at 26 weeks, when compared to 26 weeks of peer navigation to similar health services available at community-based agencies.
1) To evaluate whether 26 weeks of “one stop” integrated health services delivered in a mobile unit, supported by peer navigation, compared to 26 weeks of peer navigation to similar health services available at community-based agencies:
a) improves use of MOUD at 52 weeks
b) increases rates of viral suppression among HIV-positive individuals at 52 weeks
c) increases use of PrEP among HIV-negative individuals at 26 and 52 weeks
d) decreases opioid and polysubstance use at 26 and 52 weeks
e) decreases prevalence of bacterial STIs at 26 and 52 weeks
f) decreases fatal and non-fatal overdose events by 26 and 52 weeks
g) increases the proportion of participants with undetectable HCV RNA at 26 and 52 weeks among those with chronic HCV infection at enrollment
h) decreases HCV incidence at 52 weeks, for those who are HCV negative at enrollment
2) To evaluate whether 26 weeks of “one stop” integrated health services delivered in a mobile unit, supported by peer navigation, increases MOUD use, viral suppression, and PrEP use at 26 and 52 weeks compared to Enrollment.
3) To evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases MOUD use, viral suppression, and PrEP use at 26 and 52 weeks compared to Enrollment
4) To document the prevalence of seropositivity for SARS-CoV-2 at baseline, 26 and 52 weeks
5) To document the impact of the COVID-19 epidemic on participants’ experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs
6) To evaluate implementation of “one-stop” integrated health services using a mobile unit, supported by peer navigation, across study sites to identify mechanisms at multiple levels to:
a) Guide real-time improvements and refinements in the conduct of the study to ensure primary and secondary outcomes are met with fidelity
b) Examine the quality and process of services delivered in each study arm, particularly as these affect primary and secondary outcomes
c) Develop evidence-based guidance for policymakers on the uptake and implementation of integrated health services using peer navigation and mobile health units in urban US regions to address HIV in PWID
d) Identify factors that enhance or impede the delivery of integrated health services using a mobile unit, supported by peer navigation, on primary and secondary outcomes, including responding to the impact of COVID-19 on service delivery
7) To use mathematical modeling methods to:
a) Estimate the effect of integrated health services delivered in a mobile unit, supported by peer navigation, on reducing HIV incidence in PWID and their sexual and injection partners
b) Estimate the cost-effectiveness of the integrated health services provided in a mobile unit and supported by peer navigation