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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) | Drug | MOUD for OUD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Vine Street Clinic | Los Angeles | California | 90095 | United States | ||
| George Washington University CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32487285 | Background | Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8. | |
| 30541373 | Background | Nicholson 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 20, 2023 |
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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.
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| HIV testing | Diagnostic Test | HIV testing |
|
| HIV treatment for participants living with HIV not already in care | Drug | HIV treatment for participants living with HIV not already in care |
|
| PrEP for participants without HIV | Drug | 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 treatment | Diagnostic Test | STI testing and treatment |
|
| Primary care | Other | Primary care |
|
| Harm reduction services | Behavioral | Harm reduction services |
|
| Peer navigation | Behavioral | Peer navigation |
|
| COVID-19 testing and referral for further evaluation, care and/or treatment | Diagnostic Test | COVID-19 testing and referral for further evaluation, care and/or treatment |
|
| 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. | 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):
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) | 26 weeks and 52 weeks |
| Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks |
| 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). | 26 weeks and 52 weeks |
| Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 52 Weeks |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Bronx Prevention Center CRS | The Bronx | New York | 10451 | United States |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | United States |
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| 30500323 | Background | Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2017. NCHS Data Brief. 2018 Nov;(329):1-8. |
| 28735776 | Background | Ciccarone 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. |
| 30718120 | Background | Ciccarone 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. |
| 24758595 | Background | Volkow 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. |
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| 26760086 | Background | Compton 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. |
| 23277902 | Background | Compton 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. |
| 26106947 | Background | Strathdee 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. |
| 26922272 | Background | Platt 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. |
| 30878228 | Background | Blanco 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. |
| 27468059 | Background | Peters 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. |
| 30870405 | Background | Cranston 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. |
| 30998671 | Background | Golden MR, Lechtenberg R, Glick SN, Dombrowski J, Duchin J, Reuer JR, Dhanireddy S, Neme S, Buskin SE. Outbreak of Human Immunodeficiency Virus Infection Among Heterosexual Persons Who Are Living Homeless and Inject Drugs - Seattle, Washington, 2018. MMWR Morb Mortal Wkly Rep. 2019 Apr 19;68(15):344-349. doi: 10.15585/mmwr.mm6815a2. |
| 29910015 | Background | Williams AR, Nunes EV, Bisaga A, Pincus HA, Johnson KA, Campbell AN, Remien RH, Crystal S, Friedmann PD, Levin FR, Olfson M. Developing an opioid use disorder treatment cascade: A review of quality measures. J Subst Abuse Treat. 2018 Aug;91:57-68. doi: 10.1016/j.jsat.2018.06.001. Epub 2018 Jun 2. |
| 19020970 | Background | Malta M, Magnanini MM, Strathdee SA, Bastos FI. Adherence to antiretroviral therapy among HIV-infected drug users: a meta-analysis. AIDS Behav. 2010 Aug;14(4):731-47. doi: 10.1007/s10461-008-9489-7. Epub 2008 Nov 20. |
| 24369409 | Background | Malta M, Ralil da Costa M, Bastos FI. The paradigm of universal access to HIV-treatment and human rights violation: how do we treat HIV-positive people who use drugs? Curr HIV/AIDS Rep. 2014 Mar;11(1):52-62. doi: 10.1007/s11904-013-0196-2. |
| 29913514 | Background | Volkow ND, Wargo EM. Overdose Prevention Through Medical Treatment of Opioid Use Disorders. Ann Intern Med. 2018 Aug 7;169(3):190-192. doi: 10.7326/M18-1397. Epub 2018 Jun 19. No abstract available. |
| 32300993 | Background | Shoptaw S, Goodman-Meza D, Landovitz RJ. Collective Call to Action for HIV/AIDS Community-Based Collaborative Science in the Era of COVID-19. AIDS Behav. 2020 Jul;24(7):2013-2016. doi: 10.1007/s10461-020-02860-y. No abstract available. |
| 32314951 | Background | Green TC, Bratberg J, Finnell DS. Opioid use disorder and the COVID 19 pandemic: A call to sustain regulatory easements and further expand access to treatment. Subst Abus. 2020;41(2):147-149. doi: 10.1080/08897077.2020.1752351. |
| 32293827 | Background | National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington (DC): National Academies Press (US); 2020 Jan 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK555809/ |
| 30674334 | Background | Iyengar S, Kravietz A, Bartholomew TS, Forrest D, Tookes HE. Baseline differences in characteristics and risk behaviors among people who inject drugs by syringe exchange program modality: an analysis of the Miami IDEA syringe exchange. Harm Reduct J. 2019 Jan 23;16(1):7. doi: 10.1186/s12954-019-0280-z. |
| 26786782 | Background | Allen ST, Ruiz MS, Jones J. Assessing Syringe Exchange Program Access among Persons Who Inject Drugs (PWID) in the District of Columbia. J Urban Health. 2016 Feb;93(1):131-40. doi: 10.1007/s11524-015-0018-5. |
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| 27906906 | Background | Wejnert C, Hess KL, Hall HI, Van Handel M, Hayes D, Fulton P Jr, An Q, Koenig LJ, Prejean J, Valleroy LA. Vital Signs: Trends in HIV Diagnoses, Risk Behaviors, and Prevention Among Persons Who Inject Drugs - United States. MMWR Morb Mortal Wkly Rep. 2016 Dec 2;65(47):1336-1342. doi: 10.15585/mmwr.mm6547e1. |
| 31835068 | Background | Lapham G, Boudreau DM, Johnson EA, Bobb JF, Matthews AG, McCormack J, Liu D, Samet JH, Saxon AJ, Campbell CI, Glass JE, Rossom RC, Murphy MT, Binswanger IA, Yarborough BJH, Bradley KA; PROUD Collaborative Investigators. Prevalence and treatment of opioid use disorders among primary care patients in six health systems. Drug Alcohol Depend. 2020 Feb 1;207:107732. doi: 10.1016/j.drugalcdep.2019.107732. Epub 2019 Nov 15. |
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| 18468362 | Background | Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6. |
| 10474547 | Background | Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. |
| 30191830 | Background | Miller WC, Hoffman IF, Hanscom BS, Ha TV, Dumchev K, Djoerban Z, Rose SM, Latkin CA, Metzger DS, Lancaster KE, Go VF, Dvoriak S, Mollan KR, Reifeis SA, Piwowar-Manning EM, Richardson P, Hudgens MG, Hamilton EL, Sugarman J, Eshleman SH, Susami H, Chu VA, Djauzi S, Kiriazova T, Bui DD, Strathdee SA, Burns DN. A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet. 2018 Sep 1;392(10149):747-759. doi: 10.1016/S0140-6736(18)31487-9. |
| 28733097 | Background | Morgan JR, Schackman BR, Leff JA, Linas BP, Walley AY. Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. J Subst Abuse Treat. 2018 Feb;85:90-96. doi: 10.1016/j.jsat.2017.07.001. Epub 2017 Jul 3. |
| 38831415 | Derived | Smith LR, Perez-Brumer A, Nicholls M, Harris J, Allen Q, Padilla A, Yates A, Samore E, Kennedy R, Kuo I, Lake JE, Denis C, Goodman-Meza D, Davidson P, Shoptaw S, El-Bassel N; HPTN 094 study protocol team. A data-driven approach to implementing the HPTN 094 complex intervention INTEGRA in local communities. Implement Sci. 2024 Jun 3;19(1):39. doi: 10.1186/s13012-024-01363-x. |
| 38360750 | Derived | Goodman-Meza D, Shoptaw S, Hanscom B, Smith LR, Andrew P, Kuo I, Lake JE, Metzger D, Morrison EAB, Cummings M, Fogel JM, Richardson P, Harris J, Heitner J, Stansfield S, El-Bassel N; HPTN 094 Study Team. Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study). Trials. 2024 Feb 15;25(1):124. doi: 10.1186/s13063-023-07899-5. |
| FG001 |
| Active Control Arm (Health Services Available at Community-based Agencies) |
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. |
| Week 26 |
|
| COMPLETED | Week 52 |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services, supported by peer navigation - 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). |
| BG001 | Active Control Arm (Health Services Available at Community-based Agencies) | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Sexual Orientation | Count of Participants | Participants |
| ||||||||||||||||
| Current Housing Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| All enrolled people living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | All enrolled people living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks |
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| Secondary | 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 | All enrolled people living without HIV at enrollment | Posted | Count of Participants | Participants | 52 weeks |
|
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| Secondary | 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. | People living with HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
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| Secondary | 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):
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) | People living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
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| Secondary | Number and Percentage of Participants With Opioid and Polysubstance Use at 26 and 52 Weeks |
| This objective will be analyzed only in those giving a urine sample at the respective visit (Enrollment, week 26 and week 52). | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
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| Secondary | 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). | All enrolled participants with collected biological samples at baseline, week 26 or week 52 (Analyzed participants may wary from enrolled depending on the biological samples collected and analyzed) | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
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| Secondary | Incidence Rate and CI for All Cause and Fatal Overdose Mortality at 26 and 52 Weeks |
| All Enrolled Population | Posted | Number | 95% Confidence Interval | events per 100 person years | 26 weeks and 52 weeks |
|
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| Secondary | 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. | All enrolled participants and who had an enrollment or week 26 or week 52 visits | Posted | Number | events per 100 person years | Enrollment, 26 weeks and 52 weeks |
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| Secondary | 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. | Participants with positive HCV RNA at enrollment who had week 26 and week 52 visits | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
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| Secondary | 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. | Enrolled HCV negative participants | Posted | Number | 95% Confidence Interval | New infections per 100 Person years | 52 weeks |
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| Secondary | 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. | People living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
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| Secondary | 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. | People living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | People living with HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | People living with HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | People living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | People living without HIV at enrollment | Posted | Count of Participants | Participants | 26 weeks and 52 weeks |
|
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| Secondary | 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 | All enrolled participants with laboratory specimen collected at enrollment, week 26 and week 52 | Posted | Count of Participants | Participants | Baseline, 26 weeks, and 52 weeks |
|
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| Secondary | 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. | Number of unique interviewees reporting COVID-related impacts. Given that this objective was not pre-specified for comparison by intervention arm, results are stratified by site rather than by arm. | Posted | Count of Participants | Participants | 52 Weeks |
|
The reporting period for all participants is from the time of enrollment through when a participant exits the study (Up to 52 weeks).
In this study, the only drugs that will be dispensed or prescribed will be US FDA-approved medications for treatment or prevention of OUD, HIV, and STIs and prescriptions for contraceptives, primary care concerns, and chronic conditions, if indicated. There are no investigational products in this protocol. Therefore, monitoring and reporting of unanticipated treatment-related risks will be limited to the following: Suspected Unexpected Serious Adverse Reactions (SUSARs) to study products
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Unit Care Arm (Integrated Health Services Delivered in the Mobile Unit) | Mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services, supported by peer navigation - 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). | 4 | 224 | 59 | 224 | 0 | 224 |
| EG001 | Active Control Arm (Health Services Available at Community-based Agencies) | 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. | 15 | 223 | 71 | 223 | 0 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hypopyon | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Myiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Necrotising soft tissue infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Perineal cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic pulmonary embolism | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Wound cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Periorbital injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Stoma site pain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| HPTN Statistical Manager | HPTN Statistical & Data Management Center | 206-667-4004 | HPTN-Data-Access@scharp.org |
| Mar 9, 2023 |
| Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2025 | Jul 11, 2025 | SAP_002.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D000082922 | HIV Testing |
| D000069078 | Seroconversion |
| D011320 | Primary Health Care |
| D000086742 | COVID-19 Testing |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D055633 | Immune System Phenomena |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
| 30-49 |
|
| 50-59 |
|
| 60+ |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| BISEXUAL |
|
| GAY/LESBIAN/HOMOSEXUAL |
|
| ADDITIONAL IDENTITY |
|
| TWO SPIRIT |
|
| PREFER NOT TO ANSWER |
|
| Unhoused |
|
| Missing |
|
| New York - Bronx Prevention |
|
|
| Los Angeles - Vine Street |
|
|
| Washington DC - Washington Circle |
|
|
| Houston AIDS Research Team CRS |
|
|
| Philadelphia |
|
|
| Other |
A Generalized Linear Model (GLM) for binary outcomes using the identity link was performed with treatment arm as a covariate. Estimated difference in proportion does not accounts for Site. |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
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. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
| OG003 | Los Angeles | Los Angeles Site - Vine Street |
| OG004 | Philadelphia | Philadelphia Site |
|
|