An interventional study of Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) and HIV testing in HIV Infections, Drug Use and Opioid Use, sponsored by HIV Prevention Trials Network. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by HIV Prevention Trials Network · Not applicable, Interventional, and Prevention
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 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.
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This study's enrollment of 447 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
Drug: Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) · Diagnostic Test: HIV testing · Drug: HIV treatment for participants living with HIV not already in care · Drug: PrEP for participants without HIV · Diagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV) · Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV) · Diagnostic Test: Sexually transmitted infection (STI) testing and treatment · Other: Primary care · Behavioral: Harm reduction services · Behavioral: Peer navigation · Diagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment
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.
Diagnostic Test: HIV testing · Diagnostic Test: Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV) · Diagnostic Test: Testing and referral for treatment for hepatitis C virus (HCV) · Diagnostic Test: Sexually transmitted infection (STI) testing and treatment · Behavioral: Harm reduction services · Behavioral: Peer navigation · Diagnostic Test: COVID-19 testing and referral for further evaluation, care and/or treatment
MOUD for OUD
HIV testing
HIV treatment for participants living with HIV not already in care
PrEP for participants without HIV
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
COVID-19 testing and referral for further evaluation, care and/or treatment
Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site
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)
Time frame: 26 weeks
Number and Percentage of Participants With Documented Current Use of PrEP at Week 26 by Site
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
Time frame: 26 weeks
Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site
• 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
Time frame: 52 weeks
Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site
• Among participants living with HIV at enrollment: alive, retained, and virally suppressed (VL \<200 copies/mL) at the week 26 and 52 visits, separately.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With Documented Use of PrEP Among Participants Living Without HIV at Enrollment by Site at Week 26 and 52
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)
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks
* 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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52
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).
Time frame: 26 weeks and 52 weeks
Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks
* 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.
Time frame: 26 weeks and 52 weeks
Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks
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.
Time frame: Enrollment, 26 weeks and 52 weeks
Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment
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.
Time frame: 26 weeks and 52 weeks
Incidence Rate and CI for HCV Incidence
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.
Time frame: 52 weeks
Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm With Documented MOUD Use at Week 26 and 52
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Intervention Arm With Documented Use of PrEP at 26 and 52 Weeks
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm With Documented Use of PrEP at 26 and 52 Weeks
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.
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks by Arm
Count of SARS-CoV-2 Seropositivity at baseline, 26 and 52 weeks by arm, the following endpoint will be assessed: • Laboratory evidence of antibodies to SARS-CoV-2
Time frame: Baseline, 26 weeks, and 52 weeks
Number and Percentage of Self-reported Subjective Experiences Linked to COVID-19 by Site
Self-reported impact of COVID-19 Pandemic on substance use and services by Site: Substance Use increased reasons included: boredom/isolation, trauma from losing someone to COVID, nothing else to spend money on, increased availability of drugs. Substance Use decreased reasons included: isolation from drug-using community, reduced availability of drugs, increased cost of drugs, desire to improve health after having had COVID. Services more available reasons included: convenience of virtual health services. Services less available reasons included: service centers/offices closed, COVID vaccine requirements to get services, longer wait times, fear of people who had COVID.
Time frame: 52 Weeks
| Milestone | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Started | 224 | 223 |
| Week 26 | 180 | 176 |
| Completed | 179 | 167 |
| Not completed | 45 | 56 |
| Withdrew: Lost to follow-up | 35 | 31 |
| Withdrew: Death | 4 | 15 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Participant is either incarcerated or unable to schedule within the visit window | 6 | 8 |
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)
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| All Sites | 30 | 22 |
| New York - Bronx Prevention | 6 | 4 |
| Los Angeles - Vine Street | 4 | 7 |
| Washington DC - Washington Circle | 5 | 1 |
| Houston AIDS Research Team CRS | 13 | 6 |
| Philadelphia | 2 | 4 |
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
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| All Sites | 11 | 6 |
| New York - Bronx Prevention | 2 | 0 |
| Los Angeles - Vine Street | 5 | 1 |
| Washington DC - Washington Circle | 0 | 2 |
| Houston AIDS Research Team CRS | 2 | 1 |
| Philadelphia | 2 | 2 |
• 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
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| All Sites | 27 | 29 |
| New York - Bronx | 5 | 6 |
| Los Angeles - Vine Street | 3 | 7 |
| Washington DC - Washington Circle | 2 | 0 |
| Houston AIDS | 6 | 4 |
| Philadelphia | 11 | 12 |
• Among participants living with HIV at enrollment: alive, retained, and virally suppressed (VL \<200 copies/mL) at the week 26 and 52 visits, separately.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Week 26 : All Sites | 8 | 7 |
| Week 26 : New York - Bronx Prevention | 1 | 1 |
| Week 26: Los Angeles - Vine Street | 1 | 1 |
| Week 26: Washington DC - Washington Circle | 3 | 1 |
| Week 26: Houston AIDS Research Team CRS | 1 | 2 |
| Week 26: Philadelphia | 2 | 2 |
| Week 52: All Sites | 4 | 7 |
| Week 52: New York - Bronx Prevention | 0 | 1 |
| Week 52: Los Angeles - Vine Street | 0 | 1 |
| Week 52: Washington DC - Washington Circle | 2 | 1 |
| Week 52: Houston AIDS Research Team CRS | 1 | 2 |
| Week 52: Philadelphia | 1 | 2 |
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)
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Week 52 PrEP drugs in DBS: All Sites | 4 | 4 |
| Week 52 PrEP drugs in DBS: New York - Bronx Prevention | 0 | 0 |
| Week 52 PrEP drugs in DBS: Los Angeles - Vine Street | 2 | 0 |
| Week 52 PrEP drugs in DBS: Washington DC - Washington Circle | 0 | 1 |
| Week 52 PrEP drugs in DBS: Houston AIDS Research Team CRS | 1 | 1 |
| Week 52 PrEP drugs in DBS: Philadelphia | 1 | 2 |
| Protective Levels of PrEP Week 26: All Sites | 0 | 1 |
| Protective Levels of PrEP Week 26: New York - Bronx Prevention | 0 | 0 |
| Protective Levels of PrEP Week 26: Los Angeles - Vine Street | 0 | 0 |
| Protective Levels of PrEP Week 26: Washington DC - Washington Circle | 0 | 0 |
| Protective Levels of PrEP Week 26: Houston AIDS Research Team CRS | 0 | 0 |
| Protective Levels of PrEP Week 26: Philadelphia | 0 | 1 |
| Protective Levels of PrEP Week 52: All Sites | 1 | 1 |
| Protective Levels of PrEP Week 52: New York - Bronx Prevention | 0 | 0 |
| Protective Levels of PrEP Week 52: Los Angeles - Vine Street | 0 | 0 |
| Protective Levels of PrEP Week 52: Washington DC - Washington Circle | 0 | 0 |
| Protective Levels of PrEP Week 52: Houston AIDS Research Team CRS | 0 | 0 |
| Protective Levels of PrEP Week 52: Philadelphia | 1 | 1 |
* 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.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Opioid use: Enrollment | 221 | 214 |
| Opioid use: Week 26 | 156 | 152 |
| Opioid use: Week 52 | 148 | 132 |
| Polysubstance use: Enrollment | 218 | 203 |
| Polysubstance use: Week 26 | 151 | 147 |
| Polysubstance use: Week 52 | 147 | 125 |
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).
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Enrollment | 24 | 9 |
| Week 26 | 13 | 11 |
| Week 52 | 11 | 13 |
* 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.
| events per 100 person years | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| All Cause Mortality: Week 26 (Incidence Rate) | 2.8 (0.6 to 8.1) | 9.7 (4.7 to 17.8) |
| All Cause Mortality: Week 52 (Incidence Rate cumulative) | 1.9 (0.5 to 5.0) | 7.8 (4.4 to 12.9) |
| Overdose-Related Mortality: Week 26 (Incidence Rate) | 1.8 (0.2 to 6.7) | 4.9 (1.6 to 11.3) |
| Overdose-Related Mortality: Week 52 (Incidence Rate cumulative) | 1.5 (0.3 to 4.3) | 3.7 (1.5 to 7.5) |
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.
| events per 100 person years | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Enrollment | 179.4 | 208.4 |
| Week 26 | 88.4 | 117.6 |
| Week 52 | 190.4 | 94.8 |
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.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Participants with Undetectable HCV RNA at Week 26 | 19 | 15 |
| Participants with Undetectable HCV RNA at Week 52 | 22 | 12 |
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.
| New infections per 100 Person years | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Incidence Rate and CI for HCV Incidence | 11.30 (4.15 to 24.60) | 8.32 (2.70 to 19.42) |
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.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) |
|---|---|
| Week 26 | 30 |
| Week 52 | 27 |
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.
| Participants | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|
| Week 26 | 22 |
| Week 52 | 29 |
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.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) |
|---|---|
| Enrollment | 6 |
| Week 26 | 8 |
| Week 52 | 4 |
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.
| Participants | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|
| Enrollment | 6 |
| Week 26 | 7 |
| Week 52 | 7 |
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.
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) |
|---|---|
| Week 26 | 11 |
| Week 52 | 4 |
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.
| Participants | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|
| Week 26 | 6 |
| Week 52 | 4 |
Count of SARS-CoV-2 Seropositivity at baseline, 26 and 52 weeks by arm, the following endpoint will be assessed: • Laboratory evidence of antibodies to SARS-CoV-2
| Participants | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| Participants with specimens collected at Enrollment | 222 | 214 |
| SARS-CoV-2 Seropositivity for participants at Enrollment | 60 | 50 |
| Participants with specimens collected at Week 26 | 166 | 156 |
| SARS-CoV-2 Seropositivity for participants at Week 26 | 46 | 52 |
| Participants with specimens collected at Week 52 | 164 | 151 |
| SARS-CoV-2 Seropositivity for participants at Week 52 | 44 | 49 |
Self-reported impact of COVID-19 Pandemic on substance use and services by Site: Substance Use increased reasons included: boredom/isolation, trauma from losing someone to COVID, nothing else to spend money on, increased availability of drugs. Substance Use decreased reasons included: isolation from drug-using community, reduced availability of drugs, increased cost of drugs, desire to improve health after having had COVID. Services more available reasons included: convenience of virtual health services. Services less available reasons included: service centers/offices closed, COVID vaccine requirements to get services, longer wait times, fear of people who had COVID.
| Participants | New York | Washington DC | Houston | Los Angeles | Philadelphia |
|---|---|---|---|---|---|
| As a result of the COVID-19 Pandemic: Substance-use increased | 4 | 1 | 8 | 3 | 2 |
| As a result of the COVID-19 Pandemic: Substance-use reduced | 2 | 3 | 4 | 2 | 0 |
| As a result of the COVID-19 Pandemic: Services became more available | 1 | 0 | 2 | 3 | 1 |
| As a result of the COVID-19 Pandemic: Services became less available | 3 | 5 | 7 | 7 | 7 |
Collected over The reporting period for all participants is from the time of enrollment through when a participant exits the study (Up to 52 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | 4/224 (1.8%) | 59/224 (26.3%) | 0/224 (0%) |
| Active Control Arm (Health Services Available at Community-based Agencies) | 15/223 (6.7%) | 71/223 (31.8%) | 0/223 (0%) |
| Event | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) |
|---|---|---|
| OverdoseInjury, poisoning and procedural complications | 28/224 | 22/223 |
| PneumoniaInfections and infestations | 1/224 | 8/223 |
| CellulitisInfections and infestations | 1/224 | 7/223 |
| Abscess limbInfections and infestations | 2/224 | 6/223 |
| OsteomyelitisInfections and infestations | 2/224 | 4/223 |
| Staphylococcal bacteraemiaInfections and infestations | 1/224 | 4/223 |
| Suicidal ideationPsychiatric disorders | 4/224 | 0/223 |
| Arthritis bacterialInfections and infestations | 0/224 | 3/223 |
| BacteraemiaInfections and infestations | 0/224 | 3/223 |
| SepsisInfections and infestations | 0/224 | 3/223 |
| Age, Continuous(years) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| Mean | 43.1 ± 10.8 | 41.8 ± 10.3 | 42.4 ± 10.6 |
| Age, Customized(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| Age Category — <30 | 21 | 28 | 49 |
| Age Category — 30-49 | 132 | 138 | 270 |
| Age Category — 50-59 | 53 | 49 | 102 |
| Age Category — 60+ | 18 | 8 | 26 |
| Sex: Female, Male(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| Female | 71 | 71 | 142 |
| Male | 153 | 152 | 305 |
| Ethnicity (NIH/OMB)(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| Hispanic or Latino | 80 | 66 | 146 |
| Not Hispanic or Latino | 144 | 153 | 297 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Race (NIH/OMB)(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 12 | 10 | 22 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 47 | 48 | 95 |
| White | 120 | 121 | 241 |
| More than one race | 5 | 6 | 11 |
| Unknown or Not Reported | 40 | 36 | 76 |
| Region of Enrollment(participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| United States | 224 | 223 | 447 |
| Sexual Orientation(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| STRAIGHT/HETEROSEXUAL | 196 | 198 | 394 |
| BISEXUAL | 19 | 17 | 36 |
| GAY/LESBIAN/HOMOSEXUAL | 4 | 4 | 8 |
| ADDITIONAL IDENTITY | 2 | 2 | 4 |
| TWO SPIRIT | 0 | 1 | 1 |
| PREFER NOT TO ANSWER | 3 | 1 | 4 |
| Current Housing Status(Participants) | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Active Control Arm (Health Services Available at Community-based Agencies) | Total |
|---|---|---|---|
| Housed | 123 | 115 | 238 |
| Unhoused | 97 | 107 | 204 |
| Missing | 4 | 1 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
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