Integrated Treatment and Prevention for People Who Inject Drugs

• ClinicalTrials.gov Identifier: NCT02935296
• Recruitment Status: Completed
• First Posted: October 17, 2016
• Last Update Posted: December 24, 2018
• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): HIV Prevention Trials Network

Tracking Information

• First Submitted Date: October 12, 2016
• First Posted Date: October 17, 2016
• Last Update Posted Date: December 24, 2018
• Study Start Date: February 2015
• Actual Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2016)

• HIV incidence among network injection partners of index participants [ Time Frame: 18 months ]
  Number of HIV seroconversions to partners to control arm Index participants
• enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners [ Time Frame: 18 months ]
  Number of participants enrolled, and number of participants with a final study visit.

Original Primary Outcome Measures (submitted: October 13, 2016)

• estimating the HIV incidence among network injection partners of index participants [ Time Frame: 18 months ]
  Measured as the number of HIV seroconversions to partners to control arm Index participants
• evaluating enrollment and retention of HIV-infected PWID and their HIV-uninfected network injection partners [ Time Frame: 18 months ]
  Measured as number of participants enrolled, and number of participants with a final study visit.

Current Secondary Outcome Measures (submitted: October 20, 2016)

• HIV incidence among network injection partners of index participants in the intervention arm [ Time Frame: 18 months ]
  Number of HIV seroconversions to partners of Intervention arm participants
• Engagement in care for ART treatment services of control arm vs intervention [ Time Frame: 18 months ]
  Number of participants in both arms who report being in ART (case report forms) care, as well as testing stored plasma for HIV RNA suppression
• Number of participants in either arm engaged in substance use treatment [ Time Frame: 18 months ]
  self reported on case report forms
• size and stability of drug using networks [ Time Frame: 18 months ]
  self reported data via questionnaire of drug sharing habits and partners at each study visit
• social harms and benefits [ Time Frame: 18 months ]
  self report via questionnaire
• phylogenetics to describe HIV transmission dynamics [ Time Frame: 18 months ]
  stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study

Original Secondary Outcome Measures (submitted: October 13, 2016)

• • To estimate HIV incidence among network injection partners of index participants in the intervention arm [ Time Frame: 18 months ]
  Measured as the number of HIV seroconversions to partners of Intervention arm participants
• effect of engagement in care for ART treatment services of control arm vs intervention [ Time Frame: 18 months ]
  Measured as number of participants in both arms who report being in ART (case report forms) care, as well as testing stored plasma for HIV RNA supression
• Number of participants in either arm engaged in substance use treatment [ Time Frame: 18 months ]
  self reported on case report forms
• size and stability of drug using networks [ Time Frame: 18 months ]
  self reported data via questionnaire of drug sharing habits and partners at each study visit
• social harms and benefits [ Time Frame: 18 months ]
  self report via questionnaire
• phylogenetics to describe HIV transmission dynamics [ Time Frame: 18 months ]
  stored plasma samples from those persons who are HIV positive and those who become HIV positive during the study

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrated Treatment and Prevention for People Who Inject Drugs
• Official Title: Integrated Treatment and Prevention for People Who Inject Drugs: A Vanguard Study for a Network-based Randomized HIV Prevention Trial Comparing an Integrated Intervention Including Supported Antiretroviral Therapy to the Standard of Care
• Brief Summary: The purpose of this study is to determine the feasibility of a future trial that will assess whether an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy (ART) at any CD4 cell count and substance use treatment for HIV-infected people who inject drugs (PWID) will reduce HIV transmission to HIV-uninfected injection partners, as compared to routine care dictated by national guidelines for HIV-infected PWID.

Detailed Description

This is a multi-site, two-arm, randomized, vanguard study. Network units will consist of an HIV-infected index participant and his/her HIV-uninfected network injection partner(s). Network units will be randomized to the intervention or standard of care arms in a 1:3 ratio, stratified by site. To assess feasibility of the intervention, additional interviews will be conducted with study staff (systems navigators and counselors) and clinic-based stakeholders at each study site.

Approximately 500 Index participants and their partners will be enrolled.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: HIV Positive

Intervention

Behavioral: Integrated Intervention

systems navigation, psychosocial counseling

Study Arms

• No Intervention: Control
  Standard of Care
• Experimental: Integrated Intervention
  Standard of care plus an integrated system of psychosocial counseling and systems navigation for HIV treatment and Substance Use treatment
  Intervention: Behavioral: Integrated Intervention

Publications *

• Sivay MV, Grabowski MK, Zhang Y, Palumbo PJ, Guo X, Piwowar-Manning E, Hamilton EL, Viet Ha T, Antonyak S, Imran D, Go V, Liulchuk M, Djauzi S, Hoffman I, Miller W, Eshleman SH. Phylogenetic Analysis of Human Immunodeficiency Virus from People Who Inject Drugs in Indonesia, Ukraine, and Vietnam: HPTN 074. Clin Infect Dis. 2020 Nov 5;71(8):1836-1846. doi: 10.1093/cid/ciz1081.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2016): 1281
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2018
• Actual Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Index participants:

• Age 18-45 years at the Screening visit (age verification procedures will be defined in the Study Specific Procedures [SSP] Manual)
• Able to provide informed consent
• Active injection drug user, defined as self-report of: a) injecting drugs approximately two or more times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
• Reports sharing needles/syringes or drug solutions at least once in the last month
• HIV-infected based on a study-defined testing algorithm (defined in the SSP Manual)
• Viral load ≥1,000 copies/mL at Screening
• Willing and able to identify, recruit, and have enrolled at least one HIV-uninfected network injection partner who is eligible for study participation according to the criteria below
• Have no plans to move outside the study area for at least one year after study enrollment
• Willing to participate in intervention activities, including regular phone contact

HIV uninfected injection partners:

• Age 18-45 years at the Screening visit (age verification procedures will be defined in the SSP Manual)
• Able to provide informed consent
• Active injection drug user, defined as: a) self-report of injecting drugs approximately two times per week for the past three months, and b) ability to identify the anatomical location of the most recent injection site, as determined by study staff
• Confirmed injection partner, using referral identification cards, of index participant within the past 1 month
• HIV-uninfected based on the study-defined testing algorithm* (defined in the Study SSP Manual)
• Have no plans to move outside the study area for at least one year after study enrollment

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia, Ukraine, Vietnam

Administrative Information

• NCT Number: NCT02935296
• Other Study ID Numbers: HPTN 074; UM1AI068619 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: no individual data will be shared

• Current Responsible Party: HIV Prevention Trials Network
• Original Responsible Party: Same as current
• Current Study Sponsor: HIV Prevention Trials Network
• Original Study Sponsor: Same as current

Collaborators

• National Institute on Drug Abuse (NIDA)
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: William Miller, MD; Ohio State University

• PRS Account: HIV Prevention Trials Network
• Verification Date: December 2018