HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
Conditions
Keywords
PrEP, MOUD, PWID, HIV, ART, Opioid Use Disorder
Brief 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 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.
Interventions
DRUGMedication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)
MOUD for OUD
DIAGNOSTIC_TESTHIV testing
HIV testing
DRUGHIV treatment for participants living with HIV not already in care
HIV treatment for participants living with HIV not already in care
DRUGPrEP for participants without HIV
PrEP for participants without HIV
DIAGNOSTIC_TESTTesting 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_TESTTesting and referral for treatment for hepatitis C virus (HCV)
Testing and referral for treatment for HCV
DIAGNOSTIC_TESTSexually transmitted infection (STI) testing and treatment
STI testing and treatment
OTHERPrimary care
Primary care
BEHAVIORALHarm reduction services
Harm reduction services
BEHAVIORALPeer navigation
Peer navigation
DIAGNOSTIC_TESTCOVID-19 testing and referral for further evaluation, care and/or treatment
COVID-19 testing and referral for further evaluation, care and/or treatment
Sponsors
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Documented Current Use of MOUD at Week 26 by Site | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Documented Current Use of MOUD at Week 52 by Site | 52 weeks | • 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 |
| Number and Percentage of Participants With Viral Suppression Among People Enrolled Living With HIV, at 26 and 52 Weeks by Site | 26 weeks and 52 weeks | • Among participants living with HIV at enrollment: alive, retained, and virally suppressed (VL \<200 copies/mL) at the week 26 and 52 visits, separately. |
| Number and Percentage of Participants With Documented Use of PrEP Among Participants Living Without HIV at Enrollment by Site at Week 26 and 52 | 26 weeks and 52 weeks | 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) |
| Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks | 26 weeks 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. |
| Number and Percentage of Participants With Bacterial STIs at Enrollment, Week 26 and Week 52 | 26 weeks and 52 weeks | 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). |
| Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks | 26 weeks 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. |
| Incidence Rate for Self-reported Non-fatal Overdose Events by 26 and 52 Weeks | Enrollment, 26 weeks 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. |
| Number and Percentage of Participants With Undetectable HCV RNA Among Those With Chronic HCV Infection at Enrollment | 26 weeks and 52 weeks | 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. |
| Incidence Rate and CI for HCV Incidence | 52 weeks | 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. |
| Number and Percentage of Participants in the Intervention Arm for Documented MOUD Use at Week 26 and 52 | 26 weeks and 52 weeks | 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. |
| Number and Percentage of Participants in the Control Arm With Documented MOUD Use at Week 26 and 52 | 26 weeks and 52 weeks | 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. |
| Number and Percentage of Participants in the Intervention Arm for Viral Suppression at 26 and 52 Weeks | 26 weeks 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. |
| Number and Percentage of Participants in the Control Arm for Viral Suppression at 26 and 52 Weeks | 26 weeks 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. |
| Number and Percentage of Participants in the Intervention Arm With Documented Use of PrEP at 26 and 52 Weeks | 26 weeks 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. |
| Number and Percentage of Participants in the Control Arm With Documented Use of PrEP at 26 and 52 Weeks | 26 weeks 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. |
| Assess the Prevalence of SARS-CoV-2 Seropositivity at Baseline, 26 and 52 Weeks | Baseline, 26 weeks, and 52 weeks | 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 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 10.6 |
| Age, Customized Age Category <30 | 49 Participants |
| Age, Customized Age Category 30-49 | 270 Participants |
| Age, Customized Age Category 50-59 | 102 Participants |
| Age, Customized Age Category 60+ | 26 Participants |
| Current Housing Status Housed | 115 Participants |
| Current Housing Status Missing | 5 Participants |
| Current Housing Status Unhoused | 97 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 146 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 22 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 95 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 76 Participants |
| Race (NIH/OMB) White | 241 Participants |
| Region of Enrollment United States | 447 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 153 Participants |
| Sexual Orientation ADDITIONAL IDENTITY | 4 Participants |
| Sexual Orientation BISEXUAL | 19 Participants |
| Sexual Orientation GAY/LESBIAN/HOMOSEXUAL | 8 Participants |
| Sexual Orientation PREFER NOT TO ANSWER | 3 Participants |
| Sexual Orientation STRAIGHT/HETEROSEXUAL | 198 Participants |
| Sexual Orientation TWO SPIRIT | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 224 | 15 / 223 |
| other Total, other adverse events | 0 / 224 | 0 / 223 |
| serious Total, serious adverse events | 59 / 224 | 71 / 223 |
Outcome results
None listed