An interventional study of Standard of Care (Patient Navigation to Off-Site Clinic) and Status-Neutral Telehealth Concierge (SN-THR) in HIV, Substance Use Disorder (SUD) and HEPATITIS C (HCV), sponsored by University of Miami. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
Among 18 studies in Substance-Related Disorders by University of Miami — 2 open to participants now, 2 under way, none of them phase 3. Substance-Related Disorders · University of Miami.
Among the 18 studies in Substance-Related Disorders by University of Miami, this one is the 7th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2027, is one of 11 with no phase, and was the 18th registered.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
Browse Substance-Related Disorders studies →2 of the 18 studies in Substance-Related Disorders by University of Miami are open now, in 1 country. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18–90 · Men only
By country, each count listing its studies:
Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3 · Phase 4 1
First in 2000; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Median enrollment 173 across the 17 interventional studies, 1,008 across the 1 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Miami is the lead sponsor of 842 studies on the registry; 166 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Substance-Related Disorders by University of Miami, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is testing a novel telehealth-based, status-neutral care model for integrating HIV prevention/treatment and substance use disorder services into street-based primary care for people experiencing homelessness who use drugs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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 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.
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.
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.
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.
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 this arm receive standard patient navigation and referral services for healthcare and social support needs for one year.
Behavioral: Standard of Care (Patient Navigation to Off-Site Clinic)
Participants in this arm receive the SN-THR intervention, a multidisciplinary street medicine and telehealth program providing integrated medical care, behavioral health services, care coordination, and social support for one year.
Behavioral: Status-Neutral Telehealth Concierge (SN-THR)
Participants receive standard patient navigation and referral services, including linkage to community healthcare and social services, transportation assistance, case management, wound care, and referrals for HIV care, pre-exposure prophylaxis (PrEP), substance use treatment, mental health services, and primary care
SN-THR is a multidisciplinary street medicine and telehealth intervention that provides medical care, behavioral health services, peer support, care coordination, street-based laboratory services, and social services. Participants receive telehealth technology, motivational interviewing, medication support, and assistance addressing housing, food insecurity, and insurance barriers during the 12-month intervention period.
Antiretroviral Adherence for Treatment/Prevention
Proportion of participants adherent to Antiretroviral Therapy (ART) for HIV treatment/prevention. HIV treatment adherence (ART adherence) will be defined by HIV RNA level \<200 copies/mL for PWH. PrEP adherence will be defined by any of the following: Dried Blood Spot (DBS) tenofovir diphosphate (TFV-DP) level of 700 fmol/punch for tenofovir disoproxil fumarate (TDF); DBS TFV-DP level of 950 fmol/punch for tenofovir alafenamide (TAF); or documentation of long-acting ART/PrEP (cabotegravir injection in the previous 8 weeks or lenacapavir injection in the previous 6 months) via EHR abstraction.
Time frame: Baseline, 3, 6, 9, and 12 months
Engagement in Substance Use Disorder (SUD) Treatment
Engagement in Substance Use Disorder (SUD) treatment will be assessed as the proportion of participants who engage in treatment services. Engagement will be defined by any of the following: Documentation in the electronic health record (EHR) of an evaluation for medications for opioid use disorder (MOUD) or prescription of psychotropic medications for other substance use disorders; Attendance at individual psychotherapy or group psychotherapy sessions documented in the EHR; or self-reported attendance at Narcotics Anonymous (NA) or Alcoholics Anonymous (AA) meetings.
Time frame: Baseline, 3, 6, 9, and 12 months
Receipt of Primary Care by U.S. Preventive Services Task Force (USPSTF) Recommended Services
Primary care preventive services will be assessed as the total number of applicable U.S. Preventive Services Task Force (USPSTF)-recommended preventive services received based on participant characteristics, as determined by electronic health record (EHR) abstraction. Preventive services may include, but are not limited to, cervical cancer screening, colorectal cancer screening, breast cancer screening, lung cancer screening, abdominal aortic aneurysm screening, hypertension screening, diabetes screening, and age- and risk-appropriate USPSTF-recommended vaccinations.
Time frame: Baseline, 3, 6, 9, and 12 months
Non-fatal overdose
Non-fatal overdose will be assessed as the number of self-reported count of non-fatal overdose experiences.
Time frame: Baseline, 3, 6, 9, and 12 months
Possession of Naloxone
Possession of Naloxone will be assessed as the proportion of participants having naloxone on person at the time of assessment. Documented naloxone possession via photo.
Time frame: Baseline, 3, 6, 9, and 12 months
Medications for Opioid Use Disorder (MOUD) Adherence
Medications for opioid use disorder (MOUD) adherence will be assessed as the proportion of participants using MOUD. Adherence is defined as detection of buprenorphine or methadone on point-of-care urine drug screening (UDS) or documentation of extended-release naltrexone or extended-release buprenorphine injection administration within the previous 4 weeks, as determined by electronic health record (EHR) abstraction.
Time frame: Baseline, 3, 6, 9, and 12 months
Hepatitis C virus (HCV) cure: Sustained Virologic Response
Hepatitis C virus (HCV) cure will be assessed as the proportion of participants with a positive hepatitis C virus ribonucleic acid (HCV RNA) result at baseline who receive direct-acting antiviral (DAA) therapy and achieve a negative hepatitis C virus ribonucleic acid polymerase chain reaction (HCV RNA PCR) result at least 4 weeks after treatment completion collected with blood samples.
Time frame: Baseline, 3, 6, 9, and 12 months
Treatment of Sexually Transmitted Infections (STIs)
Treatment of sexually transmitted infections (STIs) will be assessed as the number of STI infections that resolve during the 12- month follow-up period. Resolution is defined as a negative gonorrhea or chlamydia test following a prior positive test or a fourfold reduction in syphilis titers at least 6 months after a positive test.
Time frame: Baseline, 3, 6, 9, and 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2027; primary completion for Jul 2030, 38 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 38 months is close to that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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