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Integrated Treatment and Prevention for People Who Inject Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02935296
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : December 24, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
HIV Prevention Trials Network

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Positive Behavioral: Integrated Intervention Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2015
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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
 Behavioral: Integrated Intervention
systems navigation, psychosocial counseling


Outcome Measures
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Primary Outcome Measures :
  1. HIV incidence among network injection partners of index participants [ Time Frame: 18 months ]
    Number of HIV seroconversions to partners to control arm Index participants

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Number of participants in either arm engaged in substance use treatment [ Time Frame: 18 months ]
    self reported on case report forms

  4. 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

  5. social harms and benefits [ Time Frame: 18 months ]
    self report via questionnaire

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935296


Locations
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Indonesia
CIPTO
Jakarta, Indonesia
Ukraine
Ukrainian Institute on Public Health Policy
Kiev, Ukraine
Vietnam
Pho Yen Health Center
Pho Yen, Thai Nguyen, Vietnam
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: William Miller, MD Ohio State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT02935296    
Other Study ID Numbers: HPTN 074
UM1AI068619 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no individual data will be shared
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases