HIV InfectionsINTEGRANCT04804072
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
A study testing Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing and HIV treatment for participants living with HIV not already in care in people with HIV Infections and Drug Use, run by HIV Prevention Trials Network at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Drug Use, Opioid Use
- What is being tested?
- Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing and HIV treatment for participants living with HIV not already in care
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2021to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Urine test positive for recent opioid use and with evidence of recent injection drug use ("track marks")
- Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- Able and willing to give informed consent
- Willing to start MOUD treatment
- Able to successfully complete an Assessment of Understanding
Show all 9Show fewer
- Self-reported sharing injection equipment and/or condomless sex in the last three months with partners of HIV-positive or unknown status
- Able to provide adequate locator information
- Confirmed HIV status, as defined in the HPTN 094 Study Specific Procedures Manual
Who cannot join
- Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
- Received MOUD in the 30 days prior to enrollment by self-report
- Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Houston AIDS Research Team CRS
Houston, Texas, 77030
UCLA Vine Street Clinic
Los Angeles, California, 90095
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
Bronx Prevention Center CRS
The Bronx, New York, 10451
George Washington University CRS
Washington D.C., District of Columbia, 20007
About this study
Official title: INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons Who Inject Drugs to Integrated 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).
Read the detailed description
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.
- Conditions
- HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- Being tested
- Medication for opioid-use disorder (MOUD) for opioid-use disorder (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 hepatitis A virus (HAV) and hepatitis B virus (HBV)
- Keywords
- PrEP, MOUD, PWID, HIV, ART, Opioid Use Disorder
- Medical subject headings
- HIV Infections, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)Drug
MOUD for OUD
HIV testingDiagnostic test
HIV testing
HIV treatment for participants living with HIV not already in careDrug
HIV treatment for participants living with HIV not already in care
PrEP for participants without HIVDrug
PrEP for participants without HIV
Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)Diagnostic test
Testing and referral for vaccination or treatment for HAV and HBV
Testing and referral for treatment for hepatitis C virus (HCV)Diagnostic test
Testing and referral for treatment for HCV
Sexually transmitted infection (STI) testing and treatmentDiagnostic test
STI testing and treatment
Primary careOther
Primary care
Harm reduction servicesBehavioural
Harm reduction services
Peer navigationBehavioural
Peer navigation
COVID-19 testing and referral for further evaluation, care and/or treatmentDiagnostic test
COVID-19 testing and referral for further evaluation, care and/or treatment
| Study group | Role | What they receive |
|---|---|---|
| Integrated health services delivered in the mobile unit and peer navigation | Experimental | Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. Receives: 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 |
| Peer navigation to connect them to health services available at community-based agencies | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Alive
- Retained
- Biological evidence of MOUD (any detectable Methadone or Buprenorphine)
- 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)
Measured: 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
Measured: 26 weeks
Secondary outcomes (17)
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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start2 Jun 2021
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, 1:1 study of 450 participants. Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. 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.
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804072
- Sponsor's protocol ID
- HPTN 094
- Acronym
- INTEGRA
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2021
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8.
PubMed 32487285Nicholson HL, Vincent J. Gender Differences in Prescription Opioid Misuse Among U.S. Black Adults. Subst Use Misuse. 2019;54(4):639-650. doi: 10.1080/10826084.2018.1531427. Epub 2018 Dec 13.
PubMed 30541373Allen B, Nolan ML, Kunins HV, Paone D. Racial Differences in Opioid Overdose Deaths in New York City, 2017. JAMA Intern Med. 2019 Apr 1;179(4):576-578. doi: 10.1001/jamainternmed.2018.7700.
PubMed 30742218Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2017. NCHS Data Brief. 2018 Nov;(329):1-8.
PubMed 30500323Ciccarone D. Fentanyl in the US heroin supply: A rapidly changing risk environment. Int J Drug Policy. 2017 Aug;46:107-111. doi: 10.1016/j.drugpo.2017.06.010. Epub 2017 Jul 20. No abstract available.
PubMed 28735776Ciccarone D. The triple wave epidemic: Supply and demand drivers of the US opioid overdose crisis. Int J Drug Policy. 2019 Sep;71:183-188. doi: 10.1016/j.drugpo.2019.01.010. Epub 2019 Feb 2.
PubMed 30718120Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
PubMed 24758595Kolodny A, Courtwright DT, Hwang CS, Kreiner P, Eadie JL, Clark TW, Alexander GC. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annu Rev Public Health. 2015 Mar 18;36:559-74. doi: 10.1146/annurev-publhealth-031914-122957. Epub 2015 Jan 12.
PubMed 25581144Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.
PubMed 26760086Compton WM, Volkow ND, Throckmorton DC, Lurie P. Expanded access to opioid overdose intervention: research, practice, and policy needs. Ann Intern Med. 2013 Jan 1;158(1):65-6. doi: 10.7326/0003-4819-158-1-201301010-00013. No abstract available.
PubMed 23277902Strathdee SA, Beyrer C. Threading the Needle--How to Stop the HIV Outbreak in Rural Indiana. N Engl J Med. 2015 Jul 30;373(5):397-9. doi: 10.1056/NEJMp1507252. Epub 2015 Jun 24. No abstract available.
PubMed 26106947Platt L, Easterbrook P, Gower E, McDonald B, Sabin K, McGowan C, Yanny I, Razavi H, Vickerman P. Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis. Lancet Infect Dis. 2016 Jul;16(7):797-808. doi: 10.1016/S1473-3099(15)00485-5. Epub 2016 Feb 25.
PubMed 26922272Blanco C, Volkow ND. Management of opioid use disorder in the USA: present status and future directions. Lancet. 2019 Apr 27;393(10182):1760-1772. doi: 10.1016/S0140-6736(18)33078-2. Epub 2019 Mar 14.
PubMed 30878228Peters PJ, Pontones P, Hoover KW, Patel MR, Galang RR, Shields J, Blosser SJ, Spiller MW, Combs B, Switzer WM, Conrad C, Gentry J, Khudyakov Y, Waterhouse D, Owen SM, Chapman E, Roseberry JC, McCants V, Weidle PJ, Broz D, Samandari T, Mermin J, Walthall J, Brooks JT, Duwve JM; Indiana HIV Outbreak Investigation Team. HIV Infection Linked to Injection Use of Oxymorphone in Indiana, 2014-2015. N Engl J Med. 2016 Jul 21;375(3):229-39. doi: 10.1056/NEJMoa1515195.
PubMed 27468059Cranston K, Alpren C, John B, Dawson E, Roosevelt K, Burrage A, Bryant J, Switzer WM, Breen C, Peters PJ, Stiles T, Murray A, Fukuda HD, Adih W, Goldman L, Panneer N, Callis B, Campbell EM, Randall L, France AM, Klevens RM, Lyss S, Onofrey S, Agnew-Brune C, Goulart M, Jia H, Tumpney M, McClung P, Dasgupta S, Bixler D, Hampton K; Amy Board; Jaeger JL, Buchacz K, DeMaria A Jr. Notes from the Field: HIV Diagnoses Among Persons Who Inject Drugs - Northeastern Massachusetts, 2015-2018. MMWR Morb Mortal Wkly Rep. 2019 Mar 15;68(10):253-254. doi: 10.15585/mmwr.mm6810a6. No abstract available.
PubMed 30870405
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons Who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care
- ClinicalTrials.gov ID
- NCT04804072
- Acronym / sponsor ID
- INTEGRA / HPTN 094
- Conditions
- HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- Keywords
- PrEP, MOUD, PWID, HIV, ART, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, 1:1 study of 450 participants. Participants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. 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.
| Arm | Type | Receives |
|---|---|---|
| Integrated health services delivered in the mobile unit and peer navigation | Experimental | 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 treatmentParticipants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks. |
| Peer navigation to connect them to health services available at community-based agencies | Active comparator | 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 treatmentParticipants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age
- Urine test positive for recent opioid use and with evidence of recent injection drug use ("track marks")
- Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- Able and willing to give informed consent
- Willing to start MOUD treatment
Key exclusion criteria (3 listed)
- Urine testing that is not negative for methadone within 30 days prior to Enrollment is exclusionary, unless verified hospital records show methadone received as a medication for hospitalization only during the screening period. A volunteer may provide a sample for urine testing more than once during the screening period in order to achieve a negative result. If this criterion cannot be met within 30 days from the start of screening, the individual will be considered a screen failure and the volunteer has up to two more screening chances to successfully complete the screening process again.
- Received MOUD in the 30 days prior to enrollment by self-report
- Co-enrollment in any other interventional study unless approved by the Clinical Management Committee (CMC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)MOUD for OUD | Drug | Integrated health services delivered in the mobile unit and peer navigation |
| HIV testingHIV testing | Diagnostic test | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| HIV treatment for participants living with HIV not already in careHIV treatment for participants living with HIV not already in care | Drug | Integrated health services delivered in the mobile unit and peer navigation |
| PrEP for participants without HIVPrEP for participants without HIV | Drug | Integrated health services delivered in the mobile unit and peer navigation |
| Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)Testing and referral for vaccination or treatment for HAV and HBV | Diagnostic test | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| Testing and referral for treatment for hepatitis C virus (HCV)Testing and referral for treatment for HCV | Diagnostic test | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| Sexually transmitted infection (STI) testing and treatmentSTI testing and treatment | Diagnostic test | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| Primary carePrimary care | Other | Integrated health services delivered in the mobile unit and peer navigation |
| Harm reduction servicesHarm reduction services | Behavioural | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| Peer navigationPeer navigation | Behavioural | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
| COVID-19 testing and referral for further evaluation, care and/or treatmentCOVID-19 testing and referral for further evaluation, care and/or treatment | Diagnostic test | Integrated health services delivered in the mobile unit and peer navigation, Peer navigation to connect them to health services available at community-based agencies |
Primary outcome
Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site
Time frame: 26 weeks
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)
Number and Percentage of Participants With Documented Current Use of PrEP at Week 26 by Site
Time frame: 26 weeks
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
17 secondary outcomes
Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site
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
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
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and 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
Time frame: 26 weeks and 52 weeks
Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks
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
Time frame: 26 weeks and 52 weeks
Incidence Rate and CI for HCV Incidence
Time frame: 52 weeks
Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52
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
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks
Time frame: 26 weeks and 52 weeks
Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks
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
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
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
Time frame: Baseline, 26 weeks, and 52 weeks
Number and Percentage of Self-reported Subjective Experiences Linked to COVID-19 by Site
Time frame: 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32487285Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8.
- Background: PubMed 30541373Nicholson HL, Vincent J. Gender Differences in Prescription Opioid Misuse Among U.S. Black Adults. Subst Use Misuse. 2019;54(4):639-650. doi: 10.1080/10826084.2018.1531427. Epub 2018 Dec 13.
- Background: PubMed 30742218Allen B, Nolan ML, Kunins HV, Paone D. Racial Differences in Opioid Overdose Deaths in New York City, 2017. JAMA Intern Med. 2019 Apr 1;179(4):576-578. doi: 10.1001/jamainternmed.2018.7700.
- Background: PubMed 30500323Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2017. NCHS Data Brief. 2018 Nov;(329):1-8.
- Background: PubMed 28735776Ciccarone D. Fentanyl in the US heroin supply: A rapidly changing risk environment. Int J Drug Policy. 2017 Aug;46:107-111. doi: 10.1016/j.drugpo.2017.06.010. Epub 2017 Jul 20. No abstract available.
- Background: PubMed 30718120Ciccarone D. The triple wave epidemic: Supply and demand drivers of the US opioid overdose crisis. Int J Drug Policy. 2019 Sep;71:183-188. doi: 10.1016/j.drugpo.2019.01.010. Epub 2019 Feb 2.
- Background: PubMed 24758595Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
- Background: PubMed 25581144Kolodny A, Courtwright DT, Hwang CS, Kreiner P, Eadie JL, Clark TW, Alexander GC. The prescription opioid and heroin crisis: a public health approach to an epidemic of addiction. Annu Rev Public Health. 2015 Mar 18;36:559-74. doi: 10.1146/annurev-publhealth-031914-122957. Epub 2015 Jan 12.
- Background: PubMed 26760086Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.
- Background: PubMed 23277902Compton WM, Volkow ND, Throckmorton DC, Lurie P. Expanded access to opioid overdose intervention: research, practice, and policy needs. Ann Intern Med. 2013 Jan 1;158(1):65-6. doi: 10.7326/0003-4819-158-1-201301010-00013. No abstract available.
- Background: PubMed 26106947Strathdee SA, Beyrer C. Threading the Needle--How to Stop the HIV Outbreak in Rural Indiana. N Engl J Med. 2015 Jul 30;373(5):397-9. doi: 10.1056/NEJMp1507252. Epub 2015 Jun 24. No abstract available.
- Background: PubMed 26922272Platt L, Easterbrook P, Gower E, McDonald B, Sabin K, McGowan C, Yanny I, Razavi H, Vickerman P. Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis. Lancet Infect Dis. 2016 Jul;16(7):797-808. doi: 10.1016/S1473-3099(15)00485-5. Epub 2016 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing and HIV treatment for participants living with HIV not already in care in people with HIV Infections and Drug Use, run by HIV Prevention Trials Network at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804072, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.