Trial Outcomes & Findings for INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit (NCT NCT04804072)

INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit

Documented current use of MOUD. At the Week 26 visit: 1. Alive 2. Retained 3. Biological evidence of MOUD (any detectable Methadone or Buprenorphine) 4. A MOUD prescription current at the week 26 visit or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)

Evaluate whether the intervention increases use of PrEP among people without HIV, as measured at 26 weeks, by assessing the following endpoint: • Among participants who were without HIV at enrollment: alive, retained, without HIV, with detectable PrEP drugs (Truvada or Descovy) in dried blood spot (DBS) samples, or (Cabotegravir) in plasma samples, at the Week 26 visit

• Documented use of MOUD: alive, retained, with biological evidence of MOUD (as defined above) at the week 52 visit and a MOUD prescription at 52 weeks after enrollment or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics) at the week 52 visit

• Among participants living with HIV at enrollment: alive, retained, and virally suppressed (VL \<200 copies/mL) at the week 26 and 52 visits, separately.

Evaluate whether the intervention increases use of PrEP among participants without HIV at enrollment, compared to the active control condition, by assessing the following endpoint(s): * Among participants without HIV at enrollment: alive, retained, HIV negative, with detectable PrEP drugs in DBS at the week 52 visit * Among participants without HIV at enrollment: alive, retained, HIV negative, with protective levels of PrEP drugs in DBS samples at the week 26 and 52 visits A protective level of oral PrEP is defined as: TFV-DP concentrations ≥ 800 fmol/punch in DBS among those tested for Truvada (TDF-FTC) TFV-DP concentrations ≥ 950 fmol/punch in DBS among those tested for Descovy (TAF-FTC)

* Opioid Use: Opioids (natural or synthetic) detected in urine samples for those retained at the week 26 and 52 visits (visits analyzed separately). Opioid use is defined as fentanyl use, and/or opiates and synthetic opioids use detected in urine samples at baseline, week 26 and week 52. Tests were performed at central lab. * Polysubstance use: Opioids (natural or synthetic) detected, along with stimulants (methamphetamine, cocaine), xylazine and/or benzodiazepines detected in urine samples at the week 26 and 52 visits (visits analyzed separately). Polysubstance use is defined as opioid use, along with stimulant, benzodiazepine, cocaine and/or xylazine use, as detected in urine samples at baseline, week 26 and week 52. Tests were performed at central lab.

Gonorrhea, chlamydia, or new or prevalent syphilis infection detected via local labs for those retained at the week 26 and 52 visits (visits analyzed separately). This objective will be analyzed only in those giving a specimen and having a valid test result at the respective visit (week 26 or week 52).

* All Cause Mortality : All cause death, collected on or before 26- and on or before 52-week visits, separately. * Overdose-Related Mortality: Death, with overdose as cause, collected on or before 26- and on or before 52-week visits, separately.

Self-report of non-fatal overdose, collected the last 30 days of the visits separately. Incidence rates reflect the number of events per 100 person years. Each participant reports the number of overdoses within the last 30 days, so each participant contributes 30 days of person time at each of enrollment, week 26 and week 52.

Undetectable HCV RNA at the week 26 and 52 visits (visits analyzed separately) among participants with chronic HCV at enrollment. No formal statistical test is performed for Week 26 and Week 52 separately.

HCV antibody positive at the week 52 visit among participants who are HCV antibody negative at enrollment. Person time is defined as the number of days/year between enrollment and (a) HCV infection - for participants who became HCV infected, and (b) date of the most recent negative HCV test result - for participants who do not have HCV. HCV incidence will be modeled using Poisson regression (GLM with log link), with treatment arm and site as covariates and person years as an offset.

In the intervention arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)) at 26 and 52 weeks to documented use of MOUD at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.

In the active control arm, change over time in the use of MOUD during the study, comparing documented use of MOUD (biological evidence of MOUD - any detectable medications - and a current MOUD prescription) or proof of current receipt of MOUD from a clinic that does not provide individual MOUD prescriptions (e.g., methadone clinics)) at 26 and 52 weeks to documented MOUD use at enrollment. MOUD use is assumed to be zero at enrollment due to study exclusion criteria. Follow-up endpoints will be defined as alive, retained, and having documented MOUD use.

Among participants living with HIV at enrollment: change over time in the percentage of people with viral suppression (VL\<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.

Among participants living with HIV at enrollment: change over time in the percentage of people with viral suppression (VL\<200 copies/mL), comparing 26 and 52 weeks to enrollment. Follow-up endpoints will be defined as alive, retained, and virally suppressed.

Among participants who were without HIV at enrollment: change over time in the percentage of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.

Among participants who were without HIV at enrollment: change over time in the percentage of people with detectable PrEP drugs in DBS at 26 and 52 weeks compared to enrollment. Follow-up endpoints will be defined as alive, retained, and having detectable PrEP.

Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks, the following endpoint will be assessed: • Laboratory evidence of antibodies to SARS-CoV-2